SEC Asks Enzene Biosciences to Revise Phase III Trial Protocol for Nivolumab Biosimilar
New Delhi: 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.
The company had sought permission to conduct a prospective, multicenter, randomized, double-blind, parallel-group Phase III trial comparing its biosimilar Nivolumab with the innovator product in adults with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN), progressing on or after platinum-based therapy. The study was proposed under Protocol No. ALK43/ENZ132-NIVO1, Version 1.0, dated February 14, 2025.
After detailed deliberation, the committee recommended several key modifications to the proposed protocol. 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.
Accordingly, Enzene Biosciences has been instructed to submit a revised clinical trial protocol incorporating these changes for further evaluation by the committee before initiating the study.
Nivolumab, a human monoclonal antibody targeting the programmed death-1 (PD-1) receptor, is a leading immune checkpoint inhibitor that works by enhancing the body’s immune response against cancer cells. Marketed globally under the brand name Opdivo®, it is approved for multiple cancers including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and head and neck cancers.
Enzene Biosciences Ltd, a subsidiary of Alkem Laboratories, is a biotechnology company focused on developing and manufacturing complex biosimilars and novel biologics. The SEC’s directive reflects its emphasis on ensuring scientific rigor, adequate power, and comprehensive safety assessment in biosimilar development for oncology indications.
