Glenmark Pharma announced the initiation of a multi-country Phase III 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.
Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC comprising approximately 80-85%1 of cases, and 20-30% diagnosed at Stage III2. Despite surgical options for a subset of Stage III patients, five-year survival remains poor, ranging from 36% and 26% at Stage IIIA and IIIB3 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."
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