Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer

The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: * Grade 4 neutropenia for 7 or more consecutive days. * Grade 3 to 4 neutropenia complicated by fever (temperature \>=38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection. * Grade \>=3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention. * Grade 4 non-hematologic AE. * Grade \>=3 keratopathy. In addition, any other AE that the Investigators and sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT.

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days

Population: DLT-evaluable population included all enrolled participants who received 2 cycles with at least 80% of the intended dose for both tusamitamab ravtansine and ramucirumab at each of the 2 first infusions.

The DCR was defined as the percentage of participants who achieved confirmed CR, confirmed PR or stable disease (SD) as per RECIST v1.1. The SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

The DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occured first. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only participants with confirmed CR or PR as BOR were included in the analysis.

Blood samples were collected for the measurement of Ctrough of concentrations of ramucirumab.

Time frame: Pre-infusion on Cycle 2 Day 1

Population: The PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoint are reported.

Blood samples were collected for the measurement of Ctrough of tusamitamab ravtansine.

Time frame: Pre-infusion on Cycle 2 Day 1

Population: The Pharmacokinetic (PK) population included all participants from the all-treated population with at least 1 post-baseline PK concentration (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoint are reported.

Blood samples were collected to assess the presence of ATA against tusamitamab ravtansine in plasma from all participants. ATA incidence was defined as the number of participants found to have seroconverted (treatment-induced ATAs) or boosted their pre-existing ATA response (treatment-boosted ATAs) at any time after first study drug administration.

Time frame: Upto 92.1 weeks

Population: The ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive).

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period.

Time frame: From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

The PFS was defined as the time from the first study drug administration to the date of the first documented disease progression or death due to any cause, whichever came first as per RECIST v1.1.

Time frame: Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Population: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.