By: IPP Bureau
Last updated : September 06, 2025 8:03 am
The company has received approval from DCGI to begin patient enrolment and dosing in the country
Glenmark Pharmaceuticals Ltd., a research-led, global pharmaceutical company, has 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 enrolment 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.
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.
Commenting on the announcement, Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited said, “The initiation of this pivotal Phase 3 study for Envafolimab marks an important milestone in Glenmark’s journey to reimagine possibilities in oncology. With its novel subcutaneous administration, Envafolimab has the potential to make cutting-edge immunotherapy more accessible and convenient for patients worldwide, especially in regions where healthcare resources are constrained. By advancing this trial across multiple geographies, we are reinforcing our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the greatest unmet needs in cancer treatment today.”