nivolumab biosimilar / Alkem Labs - LARVOL DELTA

The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has asked Enzene Biosciences Ltd to revise its proposed Phase III clinical trial protocol for its biosimilar of Nivolumab Injection 100 mg/10 mL vial (Medical Dialogues) - "It advised that the disease control rate (DCR) should be assessed at 12 weeks, the non-inferiority margin used for sample size calculation should be narrowed, and the pharmacokinetic (PK) study must be adequately powered. Additionally, the SEC directed that long-term efficacy endpoints should be evaluated for at least 24 weeks and that the protocol must include provisions for reporting safety data from the initial 20 percent of enrolled subjects."

Clinical protocol • Squamous Cell Carcinoma of Head and Neck