Cancer research in India: Challenges & opportunities

Primary Outcome Measures :

1. Overall Response Rate (ORR) [ Time Frame: up to 25.9 months ]ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Secondary Outcome Measures :

1. Duration of Response (DOR) [ Time Frame: up to 24.0 months ]DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

2. Disease Control Rate (DCR) [ Time Frame: up to 25.9 months ]DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

3. Progression-free Survival (PFS) [ Time Frame: up to 25.9 months ]According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.

4. Overall Survival [ Time Frame: up to 28.2 months ]Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.

5. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: up to approximately 2.3 years ]An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.

6. First-dose Cmax of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.

7. Cmax of Retifanlimab at Steady-state [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days) ]Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.

8. First-dose Tmax of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]tmax was defined as the time to the maximum concentration of retifanlimab.

9. Tmax of Retifanlimab at Steady-state [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days) ]tmax was defined as the time to the maximum concentration of retifanlimab.

10. First-dose Cmin of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.

11. Cmin of Retifanlimabv at Steady-state [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days) ]Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.

12. First-dose AUC0-t of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.

13. AUC0-t of Retifanlimab at Steady-state [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days) ]AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.