Trial Outcomes & Findings for MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia (NCT NCT03008187)

Last Updated: 2025-04-29

Results Overview

An adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the investigational medicinal product. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse events module.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

73 participants

Primary outcome timeframe

Up to 21 months

Results posted on

2025-04-29

Participant Flow

Participants were screened across 4 countries: Unites States, Italy, Spain, and Poland.

Participant milestones

Participant milestones
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 milligrams \[mg\]) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1: Dose Escalation STARTED	2	3	3	6	7	4
Part 1: Dose Escalation Received at Least 1 Dose of Study Drug	2	3	3	6	7	4
Part 1: Dose Escalation COMPLETED	2	3	3	6	7	4
Part 1: Dose Escalation NOT COMPLETED	0	0	0	0	0	0
Part 2: Dose Expansion STARTED	0	0	0	0	48	0
Part 2: Dose Expansion Received at Least 1 Dose of Study Drug	0	0	0	0	48	0
Part 2: Dose Expansion COMPLETED	0	0	0	0	48	0
Part 2: Dose Expansion NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (25 mg) n=2 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=55 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Total n=73 Participants Total of all reporting groups
Age, Continuous	47.50 years STANDARD_DEVIATION 31.820 • n=39 Participants	71.00 years STANDARD_DEVIATION 5.000 • n=41 Participants	75.33 years STANDARD_DEVIATION 8.963 • n=35 Participants	65.67 years STANDARD_DEVIATION 18.726 • n=31 Participants	65.55 years STANDARD_DEVIATION 12.060 • n=146 Participants	63.50 years STANDARD_DEVIATION 7.047 • n=19 Participants	65.58 years STANDARD_DEVIATION 12.923 • n=147 Participants
Sex: Female, Male Female	1 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants	3 Participants n=31 Participants	24 Participants n=146 Participants	1 Participants n=19 Participants	33 Participants n=147 Participants
Sex: Female, Male Male	1 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants	3 Participants n=31 Participants	31 Participants n=146 Participants	3 Participants n=19 Participants	40 Participants n=147 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	2 Participants n=146 Participants	0 Participants n=19 Participants	2 Participants n=147 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants	6 Participants n=31 Participants	53 Participants n=146 Participants	4 Participants n=19 Participants	71 Participants n=147 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	1 Participants n=147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	2 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	4 Participants n=147 Participants
Race (NIH/OMB) White	1 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants	4 Participants n=31 Participants	51 Participants n=146 Participants	4 Participants n=19 Participants	66 Participants n=147 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	2 Participants n=146 Participants	0 Participants n=19 Participants	2 Participants n=147 Participants

PRIMARY outcome

Timeframe: Up to 21 months

Population: Safety population: all participants that received at least 1 dose of MEN1703.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=2 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=55 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Number of Participants Experiencing Treatment-emergent Adverse Events	2 Participants	3 Participants	3 Participants	6 Participants	54 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 21 (first treatment cycle)

Population: Safety Population: all participants that received at least one dose of MEN1703. Here, 'Overall Number of Participants Analyzed' signifies those participants from Part 1 who were evaluable for this outcome measure.

AEs were graded according to the National Cancer Institute common terminology criteria for adverse events, version 4.03. The following AEs were considered as DLT unless they were clearly and incontrovertibly attributable to the underlying disease or to an extraneous cause: Grade 5 toxicity; Grade 4 neutropenia lasting ≥42 days from the start of the therapy cycle in absence of evidence of active acute myeloid leukemia (AML) (\<5% blasts); Grade 3 or 4 non-hematologic toxicity (with protocol-define exceptions). Only clinically significant abnormalities in laboratory findings, physical examination, vital signs, weight, or electrocardiogram were considered for DLT assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=2 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=7 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1: Number of Participants Experiencing Dose-limiting Toxicity (DLT)	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 32 months

Population: Efficacy Population: all participants in each cohort that have completed 1 cycle of treatment (considering both the treatment and the washout period) and have taken at least 75% of the study drug during the first cycle. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this Outcome Measure.

ORR was defined as the percentage of participants who had a complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with partial hematologic recovery (CRh), or morphologic leukemia-free state (MLFS) response to therapy.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=37 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Overall Response Rate (ORR)	—	0 percentage of participants	50.0 percentage of participants	0 percentage of participants	13.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 32 months

PR rate was defined as the percentage of participants who had a partial remission response to therapy.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=37 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Partial Remission (PR) Rate	—	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 32 months

DoR was defined as the time from the date of first CR, CRi, CRh, CR without minimal residual disease (CRMRD-), MLFS or PR until the date of documented relapse of any type, progressive disease or death due to disease progression for participants who achieve CR, CRi, CRh, CRMRD-, MLFS or PR. Results are reported in days.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=37 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Duration of Response (DoR)	—	NA days NA = Values were non-estimable (insufficient number of participants with events).	79.0 days NA = Values were non-estimable (insufficient number of participants with events). Only 1 participant had a response. As a consequence, the standard deviation was 0 and the confidence interval limits were not estimable.	NA days NA = Values were non-estimable (insufficient number of participants with events).	63.0 days Interval 44.0 to NA = Values were non-estimable (insufficient number of participants with events).	NA days NA = Values were non-estimable (insufficient number of participants with events).

SECONDARY outcome

Timeframe: Up to 32 months

RFS was defined as the time from the date of first CR, CRi, CRh, or CRMRD- until the date of documented relapse or death from any cause. Results are reported in days.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=37 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Relapse Free Survival (RFS)	—	NA days NA = Values were non-estimable (insufficient number of participants with events).	81.0 days NA = Values were non-estimable (insufficient number of participants with events). Only 1 participant had a response. As a consequence, the standard deviation was 0 and the confidence interval limits were not estimable.	NA days NA = Values were non-estimable (insufficient number of participants with events).	64.0 days Interval 44.0 to NA = Values were non-estimable (insufficient number of participants with events).	NA days NA = Values were non-estimable (insufficient number of participants with events).

SECONDARY outcome

Timeframe: Up to 32 months

OS was defined as the number of days between the first study drug administration and death from any cause. Results are reported in days.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=37 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Overall Survival (OS)	—	43.0 days NA = Values were non-estimable because the standard error was non-estimable due to an insufficient number of participants with events.	138.5 days Interval 63.0 to NA = Values were non-estimable (insufficient number of participants with events).	NA days Interval 108.0 to NA = Values were non-estimable (insufficient number of participants with events).	144.0 days Interval 72.0 to 287.0	42.5 days Interval 34.0 to NA = Values were non-estimable (insufficient number of participants with events).

SECONDARY outcome

Timeframe: Up to 32 months

EFS was defined as the time from the date of first study drug intake until the date of documented relapse, treatment failure, or death from any cause. Results are reported in days.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=37 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Event Free Survival (EFS)	—	15.0 days NA = Values were non-estimable because the standard error was non-estimable due to an insufficient number of participants with events.	14.0 days NA = Values were non-estimable (insufficient number of participants with events). The 2 participants with a measurable outcome reported the same result. As a consequence, standard deviation was 0 and the confidence interval limits were not estimable.	14.0 days Interval 14.0 to NA = Values were non-estimable (insufficient number of participants with events).	43.0 days Interval 42.0 to 49.0	15.0 days Interval 14.0 to NA = Values were non-estimable (insufficient number of participants with events).

SECONDARY outcome

Timeframe: Up to 21 months

Transfusion conversion rate was defined as the percentage of participants who were transfusion dependent at baseline but became transfusion independent post-baseline. Participants were classified as baseline transfusion independent if there were no red blood cells (RBC) or platelet transfusions at baseline; otherwise, the participant was considered as baseline transfusion dependent. Participants were classified post-baseline transfusion independent in the event of 56 consecutive days without any RBC or platelet transfusion post-baseline; otherwise, the participant was considered post-baseline transfusion dependent.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=4 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Transfusion Conversion Rate	25 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 21 months

Transfusion maintenance rate was defined as the percentage of participants who were transfusion independent at baseline and still maintained to be transfusion independent post-baseline. Participants were classified as baseline transfusion independent if there were no RBC or platelet transfusions at baseline; otherwise, the participant was considered as baseline transfusion dependent. Participants were classified post-baseline transfusion independent in the event of 56 consecutive days without any RBC or platelet transfusion post-baseline; otherwise, the participant was considered post-baseline transfusion dependent.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=2 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Transfusion Maintenance Rate	100 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 21 months

Allogeneic HSCT rate was defined as the percentage of participants undergoing allogeneic stem cell transplant during the study period of each participant.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=37 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Rate	2.7 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 20 months

Bone marrow aspirates/biopsies were taken at designated timepoints for evaluation of leukemic blast proportion in the bone marrow. A reduction in bone marrow blast proportion indicates increased anti-leukemic activity of the study drug.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=1 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=2 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=4 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=24 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=2 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Percentage of Participants With ≥ 50% Bone Marrow Blast Reduction	—	0 percentage of participants	50.0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Day 1 and Day 14 of Cycle 1 (pre-dose, up to 120 hours post dose) (21 days/cycle)

Population: Pharmacokinetics (PK) Population: all participants who received any dose of MEN1703 and had at least 1 measurable drug concentration. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.

Nominal blood samples were taken at designated timepoints for evaluation of concentration levels of MEN1703 in plasma. Results are reported as nanograms/milliliter (ng/mL). Standard error not reported, arithmetic coefficient of variation (CV%) reported instead.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=2 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=55 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Maximum Observed Concentration (Cmax) for MEN1703 Cycle 1 Day 1	8.77 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 29.3	33.58 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 33.5	60.55 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 88.3	73.25 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 50.4	152.94 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 54	249.00 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead.CV% = 26.8
Part 1 and Part 2: Maximum Observed Concentration (Cmax) for MEN1703 Cycle 1 Day 14	—	74.32 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 64.1	167.08 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 60.9	294.25 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 53.5	507.18 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 44	759.36 ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 97.8

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (pre-dose, up to 24 hours post dose) (21 days/cycle)

Population: Pharmacokinetics (PK) Population: all participants who received any dose of MEN1703 and had at least 1 measurable drug concentration. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.

Nominal blood samples were taken at designated timepoints for evaluation of concentration levels of MEN1703 in plasma. AUClast was calculated by the linear trapezoidal rule. Results are reported in hour times nanograms/milliliter (h\*ng/mL). Standard error not reported, arithmetic CV% reported instead.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=2 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=55 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 Participants Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for MEN1703	152.17 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 43	490.37 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 24.3	729.48 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 116.3	1016.62 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 69.5	1936.61 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 64.2	2608.31 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 47

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (pre-dose, up to 120 hours post dose) (21 days/cycle)

Population: Pharmacokinetics (PK) Population: all participants who received any dose of MEN1703 and had at least 1 measurable drug concentration. Here, 'Overall Number of Participants Analyzed' signifies those participants in Cohorts 2-6 who were evaluable for this outcome measure at the specified time point. Data was not collected for Cohort 1 for this outcome measure.

Nominal blood samples were taken at designated timepoints for evaluation of concentration levels of MEN1703 in plasma. AUC0-24 was calculated by the linear trapezoidal rule. Results are reported in h\*ng/mL. Standard error not reported, arithmetic CV% reported instead.

Outcome measures

Outcome measures
Measure	Cohort 1 (25 mg) n=3 Participants Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 Participants Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=6 Participants Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=38 Participants Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=3 Participants Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Part 1 and Part 2: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) for MEN1703	1330.03 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 78.4	2885.33 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 66.7	5574.10 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 52.6	9224.62 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 50.6	15769.60 h*ng/mL Standard Error NA Standard error not reported, arithmetic CV% reported instead. CV% = 106.3	—

Adverse Events

Cohort 1 (25 mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Cohort 2 (50 mg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 3 (75 mg)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 4 (100 mg)

Serious events: 6 serious events

Other events: 6 other events

Deaths: 1 deaths

Cohort 5 (125 mg)

Serious events: 35 serious events

Other events: 52 other events

Deaths: 35 deaths

Cohort 6 (150 mg)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 (25 mg) n=2 participants at risk Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 participants at risk Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 participants at risk Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 participants at risk Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=55 participants at risk Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 participants at risk Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Anorectal infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	14.5% 8/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Atrial tachycardia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Cardiac arrest	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Eye disorders Hyphaema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Colitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Odynophagia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Asthenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Multiple organ dysfunction syndrome	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Pyrexia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Bacteraemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations COVID-19	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Cellulitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Gastroenteritis clostridial	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Laryngitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	30.9% 17/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Pneumonia fungal	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Pneumonia pseudomonal	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Sepsis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	9.1% 5/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Septic shock	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Sinusitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Sinusitis fungal	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Splenic abscess	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Systemic infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Urinary tract infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Neutrophil count decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations SARS-CoV-2 test positive	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Cerebral venous thrombosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Haemorrhage intracranial	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Seizure	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Psychiatric disorders Suicide attempt	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.

Other adverse events

Other adverse events
Measure	Cohort 1 (25 mg) n=2 participants at risk Participants received MEN1703 (25 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 2 (50 mg) n=3 participants at risk Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 3 (75 mg) n=3 participants at risk Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 4 (100 mg) n=6 participants at risk Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 5 (125 mg) n=55 participants at risk Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Cohort 6 (150 mg) n=4 participants at risk Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Infections and infestations Gastroenteritis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Gastroenteritis clostridial	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Gingivitis	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Herpes virus infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Lung infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	100.0% 3/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 3/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	30.9% 17/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	12.7% 7/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	10.9% 6/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	23.6% 13/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Atrial flutter	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Left ventricular hypertrophy	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Pericardial effusion	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Right ventricular failure	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Cardiac disorders Tachycardia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Ear and labyrinth disorders Ear pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Endocrine disorders Adrenal mass	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Eye disorders Conjunctival haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Eye disorders Conjunctival hyperaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Eye disorders Orbital oedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Eye disorders Periorbital swelling	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Abdominal pain	100.0% 2/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	10.9% 6/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	10.9% 6/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Anal ulcer	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.4% 9/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	12.7% 7/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Faeces soft	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Gastrointestinal wall thickening	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Gingival bleeding	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Gingival pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Glossodynia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Mouth ulceration	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	47.3% 26/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Oesophagitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Oral pain	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Proctalgia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Tongue discolouration	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	23.6% 13/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Asthenia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	34.5% 19/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Chest pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Chills	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Face oedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Fatigue	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 3/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	12.7% 7/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	75.0% 3/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Gait disturbance	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Generalised oedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Malaise	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Mucosal inflammation	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Oedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Oedema peripheral	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	10.9% 6/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Pain	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Peripheral swelling	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
General disorders Pyrexia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	9.1% 5/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Hepatobiliary disorders Cholestasis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Hepatobiliary disorders Jaundice	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Bronchitis viral	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Cellulitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Clostridium difficile colitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Erysipelas	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Oral herpes	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Pharyngitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Skin bacterial infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Skin candida	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Staphylococcal skin infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Superinfection fungal	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Systemic mycosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Urinary tract infection	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Urinary tract infection bacterial	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/1 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/24 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/1 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Animal bite	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Contusion	100.0% 2/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Eye injury	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Face injury	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Overdose	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Injury, poisoning and procedural complications Transfusion reaction	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Alanine aminotransferase increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.4% 9/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	75.0% 3/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	23.6% 13/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Bilirubin conjugated increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	12.7% 7/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood bilirubin increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood cholesterol increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood creatinine increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood triglycerides increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Blood uric acid increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Brain natriuretic peptide increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Breath sounds abnormal	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations C-reactive protein increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Electrocardiogram abnormal	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Fibrin D dimer increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations International normalised ratio increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Lymphocyte count decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Lymphocyte count increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Neutrophil count decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 3/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Platelet count decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 3/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Prothrombin level increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Transaminases increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Troponin I increased	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Weight decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations Weight increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations White blood cell count decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Investigations White blood cell count increased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.4% 9/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Fluid overload	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	10.9% 6/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypertriglyceridaemia	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	14.5% 8/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	12.7% 7/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Hypophosphataemia	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	66.7% 2/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	10.9% 6/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Carotid artery stenosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Cerebral ischaemia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Dizziness	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Dizziness postural	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Dysarthria	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Dysgeusia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Headache	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 3/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	5.5% 3/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Hemiparesis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Hypoaesthesia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Neuralgia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Paraesthesia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Somnolence	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Spinal cord oedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Nervous system disorders Tremor	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Psychiatric disorders Agitation	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Psychiatric disorders Anxiety	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Psychiatric disorders Depressed mood	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Psychiatric disorders Flat affect	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Psychiatric disorders Insomnia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Renal and urinary disorders Dysuria	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Renal and urinary disorders Haematuria	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Renal and urinary disorders Proteinuria	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Renal and urinary disorders Renal failure	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Reproductive system and breast disorders Vulval ulceration	0.00% 0/1 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	4.2% 1/24 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/1 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 2/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	7.3% 4/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Respiratory failure	50.0% 1/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	33.3% 1/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	3.6% 2/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Vascular disorders Haematoma	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Vascular disorders Hypertension	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	25.0% 1/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Vascular disorders Hypotension	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	50.0% 2/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Vascular disorders Lymphoedema	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	1.8% 1/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Vascular disorders Orthostatic hypotension	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.
Vascular disorders Pallor	0.00% 0/2 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/3 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	16.7% 1/6 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/55 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.	0.00% 0/4 • Adverse events were assessed up to 21 months. All-cause mortality, survival (RFS, EFS, OS), ORR, PR rate, and DOR were assessed up to 32 months. All reported safety data based upon the Safety Population: all participants that received at least 1 dose of MEN1703.

Additional Information

Angela Capriati, MD

Menarini Ricerche

Phone: +39 055 56 80 9990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the study cannot be submitted for presentation, abstract, poster exhibition, or publication by the investigator until Menarini Ricerche S.p.A. has reviewed/commented and agreed to any publication.
Publication restrictions are in place

Restriction type: OTHER