Glenmark Pharmaceuticals Ltd., a research-driven global pharmaceutical company, has announced the initiation of a multi-country (ex-China) Phase 3 clinical trial of 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 India. Additionally, Glenmark has submitted a Clinical Trial Application (CTA) in Russia and is preparing to open further trial sites in Brazil and Mexico, expanding the global reach of this pivotal study.

This randomized, multi-center Phase 3 trial will evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC. Meanwhile, a parallel Phase 3 trial, sponsored by 3D Medicines Inc., began in China in December 2023 and is currently recruiting patients.

Lung cancer is the leading cause of cancer-related deaths globally, with NSCLC accounting for 80–85% of cases. Around 20–30% of patients are diagnosed at Stage III, where five-year survival rates remain low at about 36% for Stage IIIA and 26% for Stage IIIB. These statistics underscore the urgent need for innovative immunotherapy options like Envafolimab to improve outcomes in resectable Stage III NSCLC.

Commenting on the development, Dr. Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, said: “The initiation of this pivotal Phase 3 trial represents a significant milestone in Glenmark’s oncology journey. With its novel subcutaneous administration, Envafolimab offers the potential to make advanced immunotherapy more convenient and accessible, particularly in regions with limited healthcare resources. By conducting this study across multiple geographies, we reaffirm our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the most pressing unmet needs in cancer treatment.”