Trial Outcomes & Findings for A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02) (NCT NCT05460273)

Last Updated: 2026-03-11

Results Overview

Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

119 participants

Primary outcome timeframe

TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.

Results posted on

2026-03-11

Participant Flow

This Phase 1/2, open-label, multiple-cohort, single-arm study was conducted in participants with Advanced Non-Small-Cell Lung Cancer (NSCLC) and Triple-Negative Breast Cancer(TNBC) in China. For TNBC cohort, first participant was screened on 11Jul2022, last participant was screened on 27Apr2023. For NSCLC cohort, first participant was screened on 29Aug2022, last participant was screened on 21Mar2023.

Overall 168 participants were screened at 23 centers in China. A total of 119 participants were treated with Dato-DXd. For TNBC cohort, 106 participant was screened at 14 centers in China. 79 participants received Dato-DXd at the 14 centers. For NSCLC cohort, 62 participant was screened at 12 centers in China. 40 participants received Dato-DXd at 11 centers. Note: 3 centers screened both TNBC participants and NSCLC participants.

Participant milestones

Participant milestones
Measure	Dato-DXd_NSCLC Final Analysis with DCO on 27Nov2024	Dato-DXd_TNBC Final Analysis with DCO on 06May2024
Overall Study STARTED	40	79
Overall Study COMPLETED	13	29
Overall Study NOT COMPLETED	27	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Dato-DXd_NSCLC Final Analysis with DCO on 27Nov2024	Dato-DXd_TNBC Final Analysis with DCO on 06May2024
Overall Study Death	27	43
Overall Study Lost to Follow-up	0	7

Baseline Characteristics

A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dato-DXd_NSCLC n=40 Participants Final Analysis with DCO on 27Nov2024	Dato-DXd_TNBC n=79 Participants Final Analysis with DCO on 06May2024	Total n=119 Participants Total of all reporting groups
Age, Continuous	59.4 Year STANDARD_DEVIATION 9.7 • n=9 Participants	50.3 Year STANDARD_DEVIATION 10.2 • n=9 Participants	54.85 Year STANDARD_DEVIATION 9.95 • n=18 Participants
Sex: Female, Male Female	11 Participants n=9 Participants	79 Participants n=9 Participants	90 Participants n=18 Participants
Sex: Female, Male Male	29 Participants n=9 Participants	0 Participants n=9 Participants	29 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	40 Participants n=9 Participants	79 Participants n=9 Participants	119 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Region of Enrollment China	40 Participants n=9 Participants	79 Participants n=9 Participants	119 Participants n=18 Participants

PRIMARY outcome

Timeframe: TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.

Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=77 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)	33.8 Percentage of participants Interval 23.4 to 45.4	45.0 Percentage of participants Interval 29.3 to 61.5

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.

Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=77 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Confirmed Objective Response Rate(ORR) Assessed by Investigator	31.2 Percentage of participants Interval 21.1 to 42.7	32.5 Percentage of participants Interval 18.6 to 49.1

SECONDARY outcome

Population: FAS: Enrolled participants who have received at least one dose of treatment. The analysis for DOR assessed by investigator was based on the responders in the FAS of each cohort.

Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investgator, or death due to any cause.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=25 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=13 Participants Final Analysis with DCO on 27Nov2024
Duration of Response (DoR), Assessed by Investigator	5.8 months Interval 4.01 to 8.4	8.1 months Interval 4.2 to 11.2

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.

Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1, as assessed by ICR

Outcome measures

Outcome measures
Measure	TNBC Cohort n=77 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Disease Control Rate (DCR), Assessed by ICR	72.7 Percentage Interval 61.4 to 82.3	85 Percentage Interval 70.2 to 94.3

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.

Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=77 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Best Overall Response (BoR) , Assessed by ICR Confirmed Partial Response	33.8 Percentage	45.0 Percentage
Best Overall Response (BoR) , Assessed by ICR Confirmed Complete Response	0 Percentage	0 Percentage

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR. The analysis for TTR assessed by ICR was based on the responders in the RES of each cohort.

Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1

Outcome measures

Outcome measures
Measure	TNBC Cohort n=26 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=18 Participants Final Analysis with DCO on 27Nov2024
Time To Response (TTR) , Assessed by ICR	1.5 Month Interval 1.3 to 2.8	1.4 Month Interval 1.3 to 2.7

SECONDARY outcome

Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR, or death due to any cause.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=79 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Progression-Free Survival (PFS) , Assessed by ICR	5.3 Month Interval 4.2 to 6.9	8.0 Month Interval 5.7 to 10.8

SECONDARY outcome

Overall survival is defined as the time from the date of the first dose of study intervention to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=79 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Overall Survival (OS)	13.5 Month Interval 10.7 to Upper limit not reached	16.7 Month Interval 13.8 to 20.4

SECONDARY outcome

Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=79 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Progression-Free Survival (PFS) , Assessed by Investigator	4.3 Month Interval 4.0 to 5.6	7.0 Month Interval 5.5 to 9.5

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=77 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Disease Control Rate (DCR), Assessed by Investigator	76.6 Percentage Interval 65.6 to 85.5	85.0 Percentage Interval 70.2 to 94.3

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=77 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=40 Participants Final Analysis with DCO on 27Nov2024
Best Overall Response (BoR) , Assessed by Investigator Confirmed complete response	0 Percentage	0 Percentage
Best Overall Response (BoR) , Assessed by Investigator Confirmed partial response	31.2 Percentage	32.5 Percentage

SECONDARY outcome

Population: FAS: Enrolled participants who have received at least one dose of treatment. Participants who were enrolled but did not subsequently receive study intervention are not included in the analysis. The analysis for TTR assessed by investigator was based on the responders in the FAS of each cohort.

Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=25 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=13 Participants Final Analysis with DCO on 27Nov2024
Time To Response (TTR) , Assessed by Investigator	1.4 Month Interval 1.4 to 1.6	1.4 Month Interval 1.3 to 1.4

SECONDARY outcome

Population: PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd. The analysis for AUC was based on the patients with intensive PK collection of each cohort.

PK parameters of Total Anti-TROP2 Antibody\_Area under the curve

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody	713.9 day*ug/mL Geometric Coefficient of Variation 25.45	569.3 day*ug/mL Geometric Coefficient of Variation 24.47

SECONDARY outcome

Population: PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.

PK parameters of Total Anti-TROP2 Antibody\_Maximum observed concentration

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Total Anti-TROP2 Antibody	151.1 ug/mL Geometric Coefficient of Variation 11.62	115.5 ug/mL Geometric Coefficient of Variation 22.99

SECONDARY outcome

PK parameters of Dato-DXd\_Area under the curve

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _Dato-DXd	668.3 day*ug/mL Geometric Coefficient of Variation 21.11	504.5 day*ug/mL Geometric Coefficient of Variation 22.38

SECONDARY outcome

Population: PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.

PK parameters of Dato-DXd\_Maximum observed concentration

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd	150.9 ug/mL Geometric Coefficient of Variation 12.73	108.7 ug/mL Geometric Coefficient of Variation 11.30

SECONDARY outcome

PK parameters of MAAA-1181a\_Area under the curve

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a	17.60 day*ng/mL Geometric Coefficient of Variation 24.64	17.66 day*ng/mL Geometric Coefficient of Variation 33.09

SECONDARY outcome

Population: PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.

PK parameters of MAAA-1181a\_Maximum observed concentration

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ MAAA-1181a	2.976 ng/mL Geometric Coefficient of Variation 25.84	2.231 ng/mL Geometric Coefficient of Variation 27.51

SECONDARY outcome

Population: PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.

PK parameters of Total Anti-TROP2 Antibody\_Time to maximum plasma concentration

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Total Anti-TROP2 Antibody	4.87 Hour Interval 1.55 to 7.17	1.58 Hour Interval 1.38 to 6.83

SECONDARY outcome

Population: PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.

Time to maximum plasma concentration

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Dato-DXd	4.95 h Interval 1.83 to 7.17	1.63 h Interval 1.38 to 5.22

SECONDARY outcome

Population: PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.

PK parameters of MAAA-1181a\_Time to maximum plasma concentration

Outcome measures

Outcome measures
Measure	TNBC Cohort n=8 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=9 Participants Final Analysis with DCO on 27Nov2024
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a	6.09 Hour Interval 4.87 to 24.22	22.52 Hour Interval 6.85 to 25.07

SECONDARY outcome

Population: ADA Evaluable Set: Participants in the FAS with a non-missing baseline Dato-DXd ADA result and at least one post-baseline Dato-DXd ADA result.

The prevalence of ADA (positive at any visit)

Outcome measures

Outcome measures
Measure	TNBC Cohort n=75 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=38 Participants Final Analysis with DCO on 27Nov2024
Immunogenicity of Dato-DXd	33.3 percentage	36.8 percentage

SECONDARY outcome

Population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR. The analysis for DOR assessed by ICR was based on the responders in the RES of each cohort.

Outcome measures

Outcome measures
Measure	TNBC Cohort n=26 Participants Final Analysis with DCO on 06May2024	NSCLC Cohort n=18 Participants Final Analysis with DCO on 27Nov2024
Duration of Response (DoR), Assessed by ICR	6.7 Month Interval 4.53 to 12.6	8.3 Month Interval 5.9 to 9.4

Adverse Events

Dato-DXd_NSCLC

Serious events: 12 serious events

Other events: 38 other events

Deaths: 27 deaths

Dato-DXd_TNBC

Serious events: 13 serious events

Other events: 77 other events

Deaths: 43 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Dato-DXd_NSCLC n=40 participants at risk Final Analysis with DCO on 27Nov2024	Dato-DXd_TNBC n=79 participants at risk Final Analysis with DCO on 06May2024
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Infections and infestations Covid-19	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	2.5% 2/79 • Number of events 2 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 2 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Gastrointestinal disorders Stomatitis	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Infections and infestations Gastrointestinal infection	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Infections and infestations Infection	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Infections and infestations Periodontitis	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Infections and infestations Pneumonia	5.0% 2/40 • Number of events 2 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	7.6% 6/79 • Number of events 6 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Infections and infestations Pneumonia bacterial	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Investigations Alanine aminotransferase increased	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Metabolism and nutrition disorders Decreased appetite	7.5% 3/40 • Number of events 4 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Nervous system disorders Syncope	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Renal and urinary disorders Hydronephrosis	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Gastrointestinal disorders Ascites	0.00% 0/40 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	1.3% 1/79 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.
Injury, poisoning and procedural complications Rib fracture	2.5% 1/40 • Number of events 1 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.	0.00% 0/79 • Adverse Events had a median follow-up of 6.13 months for NSCLC cohort and 4.99 months for TNBC cohort. All-Cause Mortality was assessed from enrollment to 13 months post last subject dose with a median of 12 months follow up for the TNBC cohort, and from enrollment to 20 months post last subject dose with a median of 16.7 months follow up for the NSCLC cohort.