Glenmark Pharmaceuticals Ltd., a global research-driven pharmaceutical company, has initiated a multi-country Phase 3 clinical trial of Envafolimab, a first-in-class subcutaneous PD-L1 inhibitor, in patients with resectable Stage III non-small cell lung cancer (NSCLC).

The Drugs Controller General of India (DCGI) has granted approval for patient enrollment and dosing in India. Alongside, Glenmark has filed for clinical trial clearance in Russia and is advancing plans to establish trial sites in Brazil and Mexico, further expanding the study’s global footprint beyond China.

This pivotal, randomised, multi-centre trial will evaluate Envafolimab’s efficacy, safety, pharmacokinetics, and immunogenicity in patients with Stage IIIA and IIIB (N2) NSCLC in the neoadjuvant/adjuvant setting. A parallel Phase 3 study, sponsored by 3D Medicines Inc., has already been underway in China since late 2023.

“The initiation of this pivotal Phase 3 study for Envafolimab marks an important milestone in Glenmark’s journey to reimagine possibilities in oncology,” said Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Ltd. “Its novel subcutaneous delivery has the potential to make immunotherapy more accessible and convenient for patients worldwide, especially in regions with limited healthcare resources.”

Addressing a Major Oncology Burden

Lung cancer is the world’s leading cause of cancer-related mortality, with NSCLC accounting for 80–85% of all cases. Between 20–30% of patients are diagnosed at Stage III, where surgery remains an option for some, but five-year survival rates are still poor—approximately 36% in Stage IIIA and 26% in Stage IIIB. This underlines the urgent need for novel and more accessible immuno-oncology therapies.

About Envafolimab

Envafolimab (recombinant single-domain anti-PD-L1 fused with Fc portion of human IgG1) was originally developed by Alphamab Oncology in partnership with 3D Medicines Inc. The therapy received approval in China in 2021 as the world’s first subcutaneous anti-PD-L1 for the treatment of MSI-H/dMMR advanced solid tumours. Over 40,000 cancer patients in China have already benefited from its faster administration—requiring less than 30 seconds, comparable to a standard subcutaneous injection.

In 2024, Glenmark secured an exclusive licensing agreement from Alphamab and 3D Medicines for the development and commercialisation of Envafolimab across India, Asia Pacific (excluding Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, CIS, and Latin America. Beyond lung cancer, Envafolimab is under clinical development in multiple Phase 2 and Phase 3 studies for indications including metastatic biliary tract cancer, endometrial cancer, and renal cell carcinoma.

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By leveraging its novel administration route and broad development program, Envafolimab has the potential to significantly reduce patient burden and reshape the treatment landscape in oncology.

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