Glenmark Pharma begins Phase 3 trial of lung cancer drug; stock rises 3%

Glenmark Pharmaceuticals Ltd on Friday said it has initiated a multi-country (ex-China) Phase 3 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 secured approval from the Drugs Controller General of India (DCGI) to start patient enrollment and dosing in India. In parallel, Glenmark has filed a Clinical Trial Application (CTA) in Russia and is preparing to open additional trial sites in Brazil and Mexico, broadening the global reach of the study.

The randomized, multi-center Phase 3 trial will evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC. A separate Phase 3 study of the same drug, sponsored by 3D Medicines Inc., has been underway in China since December 2023.

Monika Tandon, Global Head of Clinical Development at Glenmark Pharma, said the initiation of this trial marks a key milestone for the company.

"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," she noted.

Following the announcement, Glenmark Pharma's shares rose 3.24 per cent to hit a day's high of Rs 2,055.15. The counter has gained around 27 per cent on a year-to-date (YTD) basis.