Glenmark Specialty S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., has announced the advancement of its multi-country Phase 3 clinical trial of Trastuzumab rezetecan (SHR‑A1811), a HER2‑targeted antibody–drug conjugate (ADC), in patients with platinum‑resistant ovarian cancer (PROC). The pivotal study is part of Glenmark’s broader strategy to build a differentiated global oncology portfolio focused on hard‑to‑treat cancers with limited therapeutic options.
India will be the first of Glenmark’s licensed markets to initiate patient enrolment for the Phase 3 trial, following approval from the Drugs Controller General of India (DCGI). Glenmark also plans to enrol patients in Australia and South Korea, subject to local regulatory clearances. The trial is aligned with Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s ongoing parent Phase 3 programme in China, enabling Glenmark to generate clinically relevant data across broader and more diverse patient populations in its territories.
The randomized, controlled, multicentre Phase 3 study is designed to evaluate the efficacy, safety and pharmacokinetics of Trastuzumab rezetecan in patients with HER2‑expressing platinum‑resistant ovarian cancer, a difficult‑to‑treat condition where current treatment options are limited and outcomes remain poor. By conducting the trial across multiple geographies, Glenmark aims to build a robust clinical evidence base from diverse patient groups and strengthen the data package supporting Trastuzumab rezetecan in its licensed markets.
Commenting on the announcement, Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited, said, “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.”
Ovarian cancer remains one of the most challenging gynaecologic malignancies worldwide and is the eighth most common cancer among women. India carries a substantial burden, ranking among the countries with the highest numbers of ovarian cancer cases and deaths. Many patients with advanced ovarian cancer treated with platinum‑based regimens experience recurrence and subsequently develop platinum resistance, underscoring the need for continued clinical development of targeted therapies that can improve options for patients with advanced and resistant disease.