Glenmark Pharmaceuticals announced the initiation of a multi-country (ex-China) 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 Company has received approval from the Drugs Controller General of India (DCGI) to begin patient enrollment and dosing in the country.

In parallel, Glenmark has submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico, further expanding the global footprint of this pivotal study.

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, while a parallel Phase 3 study of Envafolimab sponsored by 3D Medicines Inc., was initiated in December 2023 and is actively recruiting in China.