Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., has advanced its multi-country Phase 3 clinical trial of Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate, in patients with platinum-resistant ovarian cancer (PROC).

 

The randomized, controlled, multi-centre study is aligned with Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s ongoing parent Phase 3 trial in China, and is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in HER2-expressing PROC patients.

 

India has become the first market under Glenmark’s licensed territories to begin patient enrollment, following approval from the Drugs Controller General of India (DCGI). The company also plans to expand enrollment to Australia and South Korea, subject to regulatory clearances.

 

“Advancing this pivotal Phase 3 trial marks an important step in Glenmark’s journey to build a differentiated oncology pipeline for global markets. Platinum-resistant ovarian cancer remains an area of significant unmet need, and the initiation of patient enrollment in India, with additional countries planned, reflects our commitment to developing novel targeted therapies for patients with hard-to-treat cancers and limited treatment options. 

 

"This study also strengthens our ability to generate clinically relevant evidence across diverse populations.” said Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited.

 

The trial aims to generate broader clinical data across diverse patient populations to support development across Glenmark’s licensed markets.

 

Ovarian cancer remains among the most challenging gynecologic cancers globally and is the eighth most common cancer among women worldwide. India carries a significant burden of disease, ranking among the countries with the highest number of ovarian cancer cases and deaths.