Glenmark Pharmaceuticals has initiated 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 enrolment and dosing in the country.

In parallel, the company 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.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC comprising approximately 80-85% of cases, and 20-30% diagnosed at Stage III. Despite surgical options for a subset of Stage III patients, five-year survival remains poor, ranging from 36% and 26% at Stage IIIA and IIIB respectively. These outcomes highlight the urgent need for innovative, accessible immunotherapy options like Envafolimab to improve prognosis in resectable Stage III NSCLC.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.