Glenmark Initiates Global Phase 3 Trial for Novel Lung Cancer Drug

Glenmark Pharmaceuticals has also begun a global Phase 3 clinical trial with Envafolimab, a new medication to treat patients with third-stage non-small cell lung cancer (NSCLC). The shift highlights the increasing role of India in late-stage drug development against the critical problems of health in the world.

The company verified that it received the Drugs Controller General of India (DCGI) permission to initiate patient enrolment and dosing in the country. At the same time, Glenmark has also submitted a clinical trial application in Russia and is planning to implement the trial in Brazil and Mexico so that it will be widely accepted internationally.

The Envafolimab will be tested in this randomised, multi-centre Phase 3 trial to assess its efficacy, safety, pharmacokinetics, and immunogenicity in patients with advanced-stage NSCLC. The stakes in this trial are high, given that lung cancer is the leading cause of cancer-related deaths across the globe, and 80-85% of all cases of lung cancer are non-squamous lung cancer.

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Highlighting the company’s intent, Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, said, "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."

Experts in the industry see this trial as a breakthrough to advance immunotherapy and make it more accessible, mainly in markets with high treatment gaps. Glenmark's entry into late-stage oncology trials additionally extends its international presence in R&D, which is constantly in increasing demand to find innovative cancer treatment modules that enhance the survival and quality of life to patients across the globe.