Enzene Biosciences Gets SEC Approval to Conduct Phase III Pembrolizumab Trial
New Delhi: Enzene Biosciences Ltd has received recommendation from the Subject Expert Committee (SEC), under CDSCO, for grant of permission to conduct a Phase III clinical trial for its proposed biosimilar Pembrolizumab solution for infusion 100 mg/4 mL (25 mg/mL), as per revised Protocol No. ALK46/ENZ146-PEM1 Version 2.0 dated March 9, 2026, for use in combination with pemetrexed and platinum-based chemotherapy in adult patients with metastatic non-small cell lung cancer (NSCLC), following detailed evaluation of the revised study protocol.
The firm presented the updated protocol in line with earlier SEC recommendations dated December 23, 2025, proposing a multicenter, randomized, double-blind, parallel-group comparative study.
The clinical trial aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the proposed biosimilar Pembrolizumab in comparison with the reference product KEYTRUDA in patients with metastatic NSCLC.
After detailed deliberation, the committee accepted the revised protocol and recommended approval to proceed with the Phase III clinical trial as presented by the firm.
