Glenmark Kicks Off Pivotal Phase 3 Trial for Envafolimab, a Novel Subcutaneous Cancer Therapy for Lung Cancer

In a significant step forward for oncology research, Glenmark Pharmaceuticals has announced the initiation of a multi-country Phase 3 clinical trial for Envafolimab, a groundbreaking subcutaneous PD-L1 inhibitor. This pivotal study is designed to evaluate the efficacy and safety of the drug in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC).

The company has received crucial approval from the Drugs Controller General of India (DCGI), allowing it to begin patient enrollment and dosing within the country. This move reinforces India’s growing role as a hub for global clinical trials. In a parallel effort to expand the trial’s reach, Glenmark has also submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional sites in Brazil and Mexico.

This randomized, multi-center Phase 3 trial will assess Envafolimab in the neoadjuvant/adjuvant setting for patients with resectable Stage IIIA and IIIB (N2) NSCLC. This mirrors a parallel Phase 3 study sponsored by 3D Medicines Inc. that is already underway in China since December 2023, and which is actively recruiting patients.

Addressing a Critical Global Health Challenge

Lung cancer remains the leading cause of cancer-related deaths worldwide. Non-Small Cell Lung Cancer (NSCLC) accounts for the vast majority of cases, and a significant portion of patients are diagnosed at Stage III. Despite surgical intervention being an option for this group, the prognosis remains poor, with five-year survival rates at just 36% for Stage IIIA and 26% for Stage IIIB. These sobering statistics underscore the urgent global need for more effective and accessible treatment options.

Dr. Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, commented on the trial’s importance, stating, “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.”

The Innovative Promise of Envafolimab

Envafolimab is a first-of-its-kind anti-PD-L1 inhibitor that offers a significant advantage in its mode of administration. Unlike traditional intravenous immunotherapies that require time-consuming hospital visits, Envafolimab is administered via a fast, 30-second subcutaneous injection, similar to a standard injection. This unique feature promises to reduce the burden on patients, caregivers, and the healthcare system, improving convenience and adherence to treatment.

The drug was invented by Alphamab Oncology and co-developed with 3D Medicines Inc. since 2016. It received approval from China’s National Medical Products Agency (NMPA) in November 2021 as the world’s first subcutaneous anti-PD-L1 drug for certain advanced solid tumors, and has already benefited over 40,000 patients in China. Glenmark secured an exclusive license agreement in 2024 to develop, register, and commercialize Envafolimab for oncology indications across a wide range of territories, including India, Asia Pacific, the Middle East, Africa, Russia, and Latin America. The drug is currently being studied for multiple other cancer types, highlighting its broad therapeutic potential.