Glenmark Pharmaceuticals Ltd., a leading research-driven global pharmaceutical company, has announced the initiation of a multi-country Phase 3 clinical trial for Envafolimab, an innovative subcutaneous PD-L1 inhibitor, targeting patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant setting.
The trial has received approval from the Drugs Controller General of India (DCGI), allowing Glenmark to begin patient enrollment and dosing in India. Additionally, the company has submitted a Clinical Trial Application (CTA) in Russia and is preparing to open clinical trial sites in Brazil and Mexico, further expanding the study’s global reach.
The randomized, multi-center Phase 3 trial aims to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC. In parallel, a Phase 3 study of Envafolimab, sponsored by 3D Medicines Inc., was launched in December 2023 and is currently recruiting in China.
Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC accounting for nearly 80–85% of all lung cancer cases. About 20–30% of patients are diagnosed at Stage III, where treatment options remain limited. Despite surgical interventions for some Stage III patients, five-year survival rates are still low, ranging between 36% for Stage IIIA and 26% for Stage IIIB.
These statistics underscore the urgent need for innovative immunotherapy treatments like Envafolimab, which has the potential to significantly improve outcomes for patients with resectable Stage III NSCLC.
With this Phase 3 trial, Glenmark Pharmaceuticals continues to reinforce its commitment to developing accessible, next-generation cancer therapies and expanding its presence in the global oncology landscape.
