Glenmark Pharmaceuticals Ltd, through its wholly owned subsidiary Glenmark Specialty S.A., has advanced the Phase 3 clinical development of Trastuzumab rezetecan, a HER2-targeted antibody-drug conjugate (ADC), for the treatment of platinum-resistant ovarian cancer (PROC).
India will become the first country across Glenmark’s licensed markets to initiate patient enrolment for the global Phase 3 clinical trial after receiving approval from the Drugs Controller General of India (DCGI).
The company also plans to expand patient enrolment to Australia and South Korea, subject to regulatory approvals.
Trial to support global development
The multi-country Phase 3 study is aligned with Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s ongoing parent Phase 3 clinical trial in China.
Glenmark said the study is designed to generate clinically relevant data across broader and more diverse patient populations, supporting the development of Trastuzumab rezetecan across its licensed markets.
The randomised, controlled, multi-centre trial will evaluate the efficacy, safety and pharmacokinetics of the therapy in patients with HER2-expressing platinum-resistant ovarian cancer, an aggressive form of the disease where treatment options remain limited and clinical outcomes continue to be poor.
The company believes conducting the study across multiple geographies will strengthen the overall clinical data package by generating evidence from diverse patient groups.
Addressing an unmet medical need
Ovarian cancer remains one of the world’s most challenging gynaecological cancers and is the eighth most common cancer among women globally.
India continues to carry a significant disease burden, ranking among the countries with the highest number of ovarian cancer cases and deaths.
Many patients with advanced ovarian cancer who initially respond to platinum-based chemotherapy eventually develop recurrence and platinum resistance, highlighting the need for new targeted treatment options.
Building oncology pipeline
Glenmark secured the rights to develop and commercialise Trastuzumab rezetecan in September 2025 through an exclusive collaboration and licence agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd.
Under the agreement, Glenmark holds exclusive commercialisation rights across multiple international markets, excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan Region, the United States, Canada, Europe, Japan and several countries in the Commonwealth of Independent States.
The latest Phase 3 trial marks another step in the company’s strategy to strengthen its global oncology portfolio through innovative targeted therapies.
Spokesperson quote
Glenmark Pharmaceuticals, Global Head of Clinical Development, Dr Monika Tandon, 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 population.”