Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT NCT03589469)

Last Updated: 2023-08-29

Results Overview

ORR, as determined by central review according to the 2014 Lugano classification, defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

Up to 21.5 months

Results posted on

2023-08-29

Participant Flow

Participants were enrolled at 28 study sites in Italy, Switzerland, the United Kingdom, and the United States from 01 August 2018 to 09 August 2022.

Participant milestones

Participant milestones
Measure	Loncastuximab Tesirine Participants received loncastuximab tesirine as an intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg once every 3 weeks (Q3W) for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Overall Study STARTED	145
Overall Study Participants Received Treatment	145
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	134

Reasons for withdrawal

Reasons for withdrawal
Measure	Loncastuximab Tesirine Participants received loncastuximab tesirine as an intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg once every 3 weeks (Q3W) for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Overall Study Withdrawal by Subject	8
Overall Study Physician Decision	20
Overall Study Death	97
Overall Study Lost to Follow-up	8
Overall Study Miscellaneous	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Age, Continuous	62.7 years STANDARD_DEVIATION 13.63 • n=99 Participants
Sex: Female, Male Female	60 Participants n=99 Participants
Sex: Female, Male Male	85 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race/Ethnicity, Customized Race · White	130 Participants n=99 Participants
Race/Ethnicity, Customized Race · Black or African American	5 Participants n=99 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=99 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	1 Participants n=99 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=99 Participants
Race/Ethnicity, Customized Race · Other	5 Participants n=99 Participants
Region of Enrollment United States	59 Participants n=99 Participants
Region of Enrollment United Kingdom	31 Participants n=99 Participants
Region of Enrollment Italy	53 Participants n=99 Participants
Region of Enrollment Switzerland	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 21.5 months

Population: All-treated population - all participants who received at least 1 dose of treatment.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Overall Response Rate (ORR)	48.3 percentage of participants Interval 39.9 to 56.7

SECONDARY outcome

Timeframe: Up to 39 months

Population: Participants in the all-treated population who achieved a complete response (CR) or partial response (PR).

DOR defined as the time from the first documentation of tumor response to disease progression or death.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=70 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Duration of Response (DOR)	13.37 months Interval 6.87 to Upper confidence interval could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 39 months

Population: All-treated population - all participants who received at least 1 dose of treatment.

CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Complete Response (CR) Rate	24.8 percentage of participants Interval 18.0 to 32.7

SECONDARY outcome

Timeframe: Up to 39 months

Population: Participants in the all-treated population who achieved CR.

RFS was defined as the time from the documentation of CR to disease progression or death.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=36 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Relapse-free Survival (RFS)	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 40 months

Population: All-treated population - all participants who received at least 1 dose of treatment.

PFS was defined as the time between start of treatment and the first documentation of recurrence, progression, or death.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Progression-free Survival (PFS)	4.93 months Interval 2.89 to 8.31

SECONDARY outcome

Timeframe: Up to 43 months

Population: All-treated population - all participants who received at least 1 dose of treatment.

OS was defined as the time between the start of treatment and death from any cause.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Overall Survival (OS)	9.53 months Interval 6.74 to 11.47

SECONDARY outcome

Timeframe: Up to 599 days

Population: All-treated population - all participants who received at least 1 dose of treatment.

An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with treatment. A TEAE was an adverse event with an onset that began or worsened on or after the first dose date and until 30 days after the last dose date, or start of a new anticancer therapy/procedure, whichever came earlier. TEAE assessments also included those per the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥3 AEs and serious TEAEs. AEs were graded using CTCAE version 4 and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. For events not listed in the CTCAE criteria, the same grading was used.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) Any TEAE	143 Participants
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) Grade ≥3 TEAE	107 Participants
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) Serious TEAE	57 Participants

SECONDARY outcome

Timeframe: Baseline up to 599 days

Population: All-treated population - all participants who received at least 1 dose of treatment.

Clinical laboratory tests included hematology and chemistry. Clinically significant changes were determined by the Investigator.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests	83 Participants

SECONDARY outcome

Timeframe: Baseline up to 599 days

Population: All-treated population - all participants who received at least 1 dose of treatment.

Vital sign measurements included arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants

SECONDARY outcome

Timeframe: Baseline and end of treatment (up to 599 days)

Population: All-treated population - all participants who received at least 1 dose of treatment. Results are presented for participants with data available for analysis at end of treatment.

ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following: * 0 = fully active, able to carry on all pre-disease performance without restriction * 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work * 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours * 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours * 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair * 5 = dead

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment Baseline · ECOG score 2	9 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment Baseline · ECOG score 0	58 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment Baseline · ECOG score 1	78 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment Baseline · ECOG score 3	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment Baseline · ECOG score 4	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment Baseline · ECOG score 5	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment End of treatment · ECOG score 0	44 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment End of treatment · ECOG score 1	50 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment End of treatment · ECOG score 2	14 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment End of treatment · ECOG score 3	2 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment End of treatment · ECOG score 4	1 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment End of treatment · ECOG score 5	0 Participants

SECONDARY outcome

Timeframe: Baseline up to 599 days

Population: All-treated population - all participants who received at least 1 dose of treatment.

Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) QTcB maximum change from baseline: >30, <=60 msec	30 Participants
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) QTcB maximum change from baseline: >60 msec	4 Participants
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) QTcF maximum change from baseline: >30, <=60 msec	23 Participants
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) QTcF maximum change from baseline: >60 msec	1 Participants

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose and end of infusion

Population: Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=142 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 1	2430 ng/mL Geometric Coefficient of Variation 38.8
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	2734 ng/mL Geometric Coefficient of Variation 35.8
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 3	1694 ng/mL Geometric Coefficient of Variation 47.6
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 1	3267 ng/mL Geometric Coefficient of Variation 36.7
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	3756 ng/mL Geometric Coefficient of Variation 31.3
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 3	2581 ng/mL Geometric Coefficient of Variation 41.9
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 SG3199 Cycle 1	0.0410 ng/mL Geometric Coefficient of Variation 56.6
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 SG3199 Cycle 2	0.0490 ng/mL Geometric Coefficient of Variation 78.8
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 SG3199 Cycle 3	0.0320 ng/mL Geometric Coefficient of Variation 20.3

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

Population: PK population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=143 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 1	15850 day*ng/mL Geometric Coefficient of Variation 105
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	23913 day*ng/mL Geometric Coefficient of Variation 67.1
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 1	22160 day*ng/mL Geometric Coefficient of Variation 106
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	33762 day*ng/mL Geometric Coefficient of Variation 67.2
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 SG3199 Cycle 1	0.00400 day*ng/mL Geometric Coefficient of Variation 576
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 SG3199 Cycle 2	0.00100 day*ng/mL Geometric Coefficient of Variation 204

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=99 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 1	19825 day*ng/mL Geometric Coefficient of Variation 52.9
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	26902 day*ng/mL Geometric Coefficient of Variation 33.4
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 1	25778 day*ng/mL Geometric Coefficient of Variation 61.3
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	37761 day*ng/mL Geometric Coefficient of Variation 30.4

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=90 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 1	8.85 days Geometric Coefficient of Variation 53.5
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	15.2 days Geometric Coefficient of Variation 31.7
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 1	8.66 days Geometric Coefficient of Variation 54.6
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	20.9 days Geometric Coefficient of Variation 56.5

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

Population: Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=99 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 1	0.458 L/day Geometric Coefficient of Variation 47.6
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	0.331 L/day Geometric Coefficient of Variation 32.0
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 1	0.418 L/day Geometric Coefficient of Variation 56.5
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	0.285 L/day Geometric Coefficient of Variation 31.3

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

Population: Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=90 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 1	4.24 liters Geometric Coefficient of Variation 39.6
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	6.40 liters Geometric Coefficient of Variation 36.5
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 1	4.10 liters Geometric Coefficient of Variation 36.4
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	7.54 liters Geometric Coefficient of Variation 58.9

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

Population: Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre- Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

AI is the ratio of AUC0-last for each cycle divided by AUC0-last of the previous cycle.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=90 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Total Antibody Cycle 2	2.07 ratio Geometric Coefficient of Variation 38.1
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 Conjugated Antibody Cycle 2	1.65 ratio Geometric Coefficient of Variation 18.5

SECONDARY outcome

Timeframe: Up to 599 days

Population: All-treated population - all participants who received at least 1 dose of treatment.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=145 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine Confirmed Positive ADA Pre-dose	1 Participants
Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine Confirmed Positive ADA Post-dose Only	0 Participants
Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine Confirmed Positive ADA Anytime	1 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 2 to 26 (cycle duration of 3 weeks), and end of treatment (up to 599 days)

Population: Patient reported outcome (PRO) population. Only participants with data available for analysis are included. Overall number of participants analyzed prepresents all participants who contributed data to this assessment, though not all participants contributed data to each time point.

EQ-5D-5L is designed as an international, standardized, instrument for describing and evaluating quality of life (QoL). In the EQ-5D-5L VAS participants are asked to indicate their health state today on a VAS with the endpoints labeled 'the best health you can imagine' (score 100) and 'the worst health you can imagine' (score 0). A higher score on the VAS indicates better health related QoL. A positive change from baseline indicates an improvement in health related QoL.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=130 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 2 Day 1	-0.1 score on a scale Standard Deviation 15.97
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 3 Day 1	1.3 score on a scale Standard Deviation 16.85
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 4 Day 1	2.8 score on a scale Standard Deviation 15.00
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 5 Day 1	2.8 score on a scale Standard Deviation 13.50
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 6 Day 1	3.0 score on a scale Standard Deviation 17.45
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 7 Day 1	4.0 score on a scale Standard Deviation 12.91
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 8 Day 1	7.3 score on a scale Standard Deviation 12.87
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 9 Day 1	7.7 score on a scale Standard Deviation 15.69
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 10 Day 1	12.2 score on a scale Standard Deviation 15.64
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 11 Day 1	11.8 score on a scale Standard Deviation 17.62
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 12 Day 1	16.3 score on a scale Standard Deviation 16.06
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 13 Day 1	6.0 score on a scale Standard Deviation 16.54
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 14 Day 1	12.2 score on a scale Standard Deviation 15.43
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 15 Day 1	6.6 score on a scale Standard Deviation 12.36
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 16 Day 1	5.5 score on a scale Standard Deviation 13.70
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 17 Day 1	8.3 score on a scale Standard Deviation 13.62
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 18 Day 1	11.0 score on a scale Standard Deviation 11.53
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 19 Day 1	11.5 score on a scale Standard Deviation 16.26
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 20 Day 1	23.0 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 21 Day 1	16.5 score on a scale Standard Deviation 9.19
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 22 Day 1	16.5 score on a scale Standard Deviation 9.19
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 23 Day 1	23.0 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 24 Day 1	23.0 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 25 Day 1	23.0 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 26 Day 1	23.0 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) End of treatment	-8.3 score on a scale Standard Deviation 19.85

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 2 to 25 (cycle duration of 3 weeks), and end of treatment (up to 599 days)

Population: PRO population. Only participants with data available for analysis are included. Overall number of participants analyzed represents all participants who contributed data to this assessment, though not all participants contributed data to each time point.

Composed of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the 15-item LymS. The FACT-G questionnaire contains 27 items covering 4 core health related quality of life (QoL) subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The LymS addresses issues including pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. Score range for the LymS was 0 - 60, where a higher score indicates less symptoms. The LymS score is reported. A positive change from baseline indicates an improvement in health related QoL.

Outcome measures

Outcome measures
Measure	Loncastuximab Tesirine n=130 Participants Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 18 Day 1	-5.00 score on a scale Standard Deviation 7.937
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 19 Day 1	-1.00 score on a scale Standard Deviation 4.243
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 20 Day 1	-2.25 score on a scale Standard Deviation 4.596
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 21 Day 1	-0.50 score on a scale Standard Deviation 2.121
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 22 Day 1	-1.00 score on a scale Standard Deviation 2.828
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 23 Day 1	1.00 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 25 Day 1	1.00 score on a scale Standard Deviation NA Standard deviation could not be calculated as n = 1.
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) End of treatment	-1.19 score on a scale Standard Deviation 9.042
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 2 Day 1	0.95 score on a scale Standard Deviation 7.114
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 3 Day 1	1.34 score on a scale Standard Deviation 8.764
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 4 Day 1	2.09 score on a scale Standard Deviation 8.832
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 5 Day 1	0.16 score on a scale Standard Deviation 8.506
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 6 Day 1	1.16 score on a scale Standard Deviation 9.918
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 7 Day 1	1.00 score on a scale Standard Deviation 11.474
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 8 Day 1	3.43 score on a scale Standard Deviation 10.141
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 9 Day 1	2.17 score on a scale Standard Deviation 9.498
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 10 Day 1	3.18 score on a scale Standard Deviation 11.769
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 11 Day 1	4.35 score on a scale Standard Deviation 13.053
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 12 Day 1	4.90 score on a scale Standard Deviation 11.140
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 13 Day 1	2.01 score on a scale Standard Deviation 16.871
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 14 Day 1	0.63 score on a scale Standard Deviation 17.442
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 15 Day 1	-3.27 score on a scale Standard Deviation 7.691
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 16 Day 1	-8.04 score on a scale Standard Deviation 10.561
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS) Cycle 17 Day 1	-6.88 score on a scale Standard Deviation 9.360

Adverse Events

Loncastuximab Tesirine

Serious events: 57 serious events

Other events: 139 other events

Deaths: 97 deaths

Serious adverse events

Serious adverse events
Measure	Loncastuximab Tesirine n=145 participants at risk Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Blood and lymphatic system disorders Febrile neutropenia	3.4% 5/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Blood and lymphatic system disorders Anaemia	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Blood and lymphatic system disorders Neutropenia	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Cardiac disorders Pericardial effusion	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Cardiac disorders Pericarditis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Abdominal pain	2.1% 3/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Ascites	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Diarrhoea	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Dysphagia	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Intestinal obstruction	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Small intestinal obstruction	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Small intestinal perforation	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Pyrexia	2.8% 4/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Non-cardiac chest pain	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Disease progression	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Face oedema	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Fatigue	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Oedema peripheral	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Pain	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Pneumonia	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Escherichia sepsis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Influenza	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Klebsiella infection	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Lung infection	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Metapneumovirus infection	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Pneumonia fungal	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Rhinovirus infection	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Sepsis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Septic shock	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Soft tissue infection	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Infections and infestations Urinary tract infection bacterial	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Injury, poisoning and procedural complications Fall	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hypercalcaemia	4.1% 6/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Dehydration	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hyponatraemia	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Musculoskeletal and connective tissue disorders Neck pain	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Nervous system disorders Headache	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Nervous system disorders Facial nerve disorder	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Nervous system disorders Psychomotor skills impaired	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Nervous system disorders Syncope	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Psychiatric disorders Mental status changes	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Psychiatric disorders Confusional state	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Psychiatric disorders Intentional self-injury	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Renal and urinary disorders Acute kidney injury	1.4% 2/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Renal and urinary disorders Hydronephrosis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Renal and urinary disorders Ureterolithiasis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 3/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Cough	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Vascular disorders Deep vein thrombosis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Vascular disorders Embolism	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Vascular disorders Haematoma	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Injury, poisoning and procedural complications Postoperative hypotension	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Vascular disorders Thrombosis	0.69% 1/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.

Other adverse events

Other adverse events
Measure	Loncastuximab Tesirine n=145 participants at risk Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
Blood and lymphatic system disorders Neutropenia	40.0% 58/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Blood and lymphatic system disorders Thrombocytopenia	33.1% 48/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Blood and lymphatic system disorders Anaemia	26.2% 38/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Blood and lymphatic system disorders Leukopenia	14.5% 21/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Blood and lymphatic system disorders Lymphopenia	7.6% 11/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Cardiac disorders Tachycardia	7.6% 11/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Nausea	23.4% 34/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Diarrhoea	17.2% 25/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Vomiting	13.1% 19/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Constipation	11.7% 17/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Gastrointestinal disorders Abdominal pain	11.0% 16/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Fatigue	27.6% 40/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Oedema peripheral	19.3% 28/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Pyrexia	17.2% 25/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
General disorders Asthenia	9.7% 14/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Investigations Gamma-glutamyltransferase increased	42.1% 61/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Investigations Blood alkaline phosphatase increased	20.0% 29/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Investigations Alanine aminotransferase increased	15.2% 22/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Investigations Aspartate aminotransferase increased	15.9% 23/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Investigations Weight increased	6.9% 10/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hypophosphataemia	15.9% 23/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Decreased appetite	15.2% 22/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hypokalaemia	15.9% 23/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hypomagnesaemia	13.8% 20/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hypocalcaemia	8.3% 12/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hyperglycaemia	7.6% 11/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Metabolism and nutrition disorders Hyponatraemia	6.2% 9/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Musculoskeletal and connective tissue disorders Back pain	6.2% 9/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 9/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Musculoskeletal and connective tissue disorders Neck pain	5.5% 8/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Nervous system disorders Headache	10.3% 15/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Nervous system disorders Dizziness	6.2% 9/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Psychiatric disorders Insomnia	11.0% 16/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Cough	22.1% 32/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.7% 17/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.7% 14/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Skin and subcutaneous tissue disorders Rash	13.1% 19/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Skin and subcutaneous tissue disorders Pruritus	13.1% 19/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Skin and subcutaneous tissue disorders Erythema	10.3% 15/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Skin and subcutaneous tissue disorders Photosensitivity reaction	10.3% 15/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.5% 8/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Vascular disorders Hypotension	6.9% 10/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Vascular disorders Hypertension	5.5% 8/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.5% 8/145 • Up to 43 months All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.

Additional Information

Clinical Trials Information

ADC Therapeutics SA

Phone: 954-903-7994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI can publish after first multi-site publication or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on PI is sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period \>60 but ≤180 days from time submitted to sponsor review. Sponsor can't require changes to the comms, extend embargo or require changes to comms, except removing confidential info that are not results
Publication restrictions are in place

Restriction type: OTHER