INTP58 (pembrolizumab biosimilar) / Intas - LARVOL DELTA

CDSCO Committee Seeks Efficacy-Focused Redesign of Intas' Pembrolizumab Clinical Trial (Medical Dialogues) - "The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has advised Intas Pharmaceuticals to revise and resubmit its proposed Phase I/III clinical trial protocol for Pembrolizumab Concentrate for Solution for Infusion 100 mg /4 mL Vial (25 mg/mL)....The committee recommended that efficacy should be included as one of the primary endpoints of the study. It further directed that a non-inferiority margin of 10–12% be applied to ensure the statistical robustness of the trial. In line with these modifications, the panel also instructed the firm to recalculate the sample size to adequately power the study."

Clinical protocol • Non Small Cell Lung Cancer

Intas Pharma Told To Revise Phase I, III Pembrolizumab Trial Protocol (Medical Dialogues) - "At the recent SEC meeting for Oncology, the expert panel reviewed the Phase I/III study protocol for Pembrolizumab concentrate for solution for infusion (100 mg/4 mL vial; 25mg/mL)...After detailed deliberation, the committee opined that the firm shall submit the following justification for further review by the committee. 1. PFS and OS should be adequately powered and included as endpoints. 2. Inferiority margin should be narrowed. 3. The dose of Paclitaxel should be reduced 4. Study duration should be increased, and OS should be assessed at around 52 weeks 5. Subgroup analysis should be as per PD-L1 expression also."

Clinical protocol • New trial • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer