Glenmark Initiates Multi-Country Phase 3 Clinical Trial for Envafolimab in Resectable Stage III NSCLC

Glenmark Pharmaceuticals Ltd. has initiated a multi-country Phase 3 Clinical Trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant setting. The trial is approved by the DCGI in India and Clinical Trial Applications are underway in Russia, Brazil, and Mexico. The randomized, multi-center, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC. Envafolimab, invented by Alphamab Oncology and co-developed with 3D Medicines Inc., is approved by National Medical Products Agency (NMPA) in China for the treatment of advanced unresectable or metastatic solid tumors with MSI-H/dMMR. Glenmark Pharmaceuticals Ltd. has an exclusive license for development, registration and commercialization of oncology indications of Envafolimab in India, Asia Pacific (except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, Commonwealth of Independent States and Latin America.