Glenmark begins key cancer drug clinical trial for lung cancer treatment

Glenmark Pharmaceuticals Ltd. is commencing a multi-country Phase 3 clinical trial for Envafolimab, a subcutaneous PD-L1 inhibitor, targeting resectable Stage III Non-Small Cell Lung Cancer (NSCLC). The Drugs Controller General of India (DCGI) has approved patient enrollment and dosing in India, with Clinical Trial Applications also submitted in Russia. Sites are also being prepared in Brazil and Mexico.

This randomized, multi-center trial will evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC. A parallel Phase 3 study of Envafolimab, sponsored by 3D Medicines Inc., initiated in December 2023, is currently recruiting in China. This initiative aims to address the urgent need for accessible immunotherapy options, as lung cancer remains a leading cause of cancer-related deaths worldwide.

Envafolimab, a novel anti-PD-L1 inhibitor, was approved in China in November 2021 for advanced unresectable or metastatic solid tumors with MSI-H/dMMR. Glenmark holds an exclusive license for its development, registration, and commercialization in oncology indications across India, Asia Pacific (excluding specific countries), the Middle East, Africa, Russia, CIS, and Latin America.