Glenmark rises by 3% on DCGI approval to conduct Phase 3 trial for cancer drug Envafolimab

Shares of Glenmark Pharmaceuticals rose by 3% after it announced receiving approval of a multi-country (ex-China) Phase 3 Clinical Trial for Envafolimab, a drug for lung cancer treatment. The Company has received approval from the Drugs Controller General of India (DCGI) to begin patient enrolment and dosing in the country.

At the time of reporting, the shares of the pharma major were trading at ₹2,051.40 apiece, while recording an intraday high of ₹2,055.20. The current price is lower than its 52-week high of ₹2,284.80, and its current market capitalisation stands at ₹57,850 crore. 

Envafolimab is a novel subcutaneous PD-L1 inhibitor drug that will be tested in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant settings. The randomised, multi-centre, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC. 

The statement reported that lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC comprising approximately 80-85% of cases, and 20-30% diagnosed at Stage III. Despite surgical options for a subset of Stage III patients, five-year survival remains poor, ranging from 36% and 26% at Stage IIIA and IIIB, respectively. “These outcomes highlight the urgent need for innovative, accessible immunotherapy options like Envafolimab to improve prognosis in resectable Stage III NSCLC,” mentioned the statement. 

“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,” said Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited. 

She added that by advancing this trial across multiple geographies, it would reinforce commitment to transforming the standard of care in Stage III NSCLC and addressing one of the greatest unmet needs in cancer treatment.