Glenmark initiates multi-nation Phase 3 clinical trial for lung cancer drug

Glenmark Pharmaceuticals on Friday said it has initiated a multi-country Phase 3 clinical trial for Envafolimab, a novel drug for third-stage non-small cell lung cancer.

The company said it has received approval from the Drugs Controller General of India to begin patient enrolment and dosing in the country.

In parallel, the drug firm has submitted a clinical trial application in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico, Glenmark said in a statement.


The randomised, multi-centre, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with third-stage non-small cell lung cancer (NSCLC).

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC comprising around 80-85 per cent of cases.

"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," Glenmark Pharmaceuticals Global Head of Clinical Development Monika Tandon said.

Shares of Glenmark settled 3.3 per cent up at Rs 2,056.35 apiece on the BSE.