DCGI Clears Glenmark's Phase 3 Trial of HER2-Targeted Ovarian Cancer Therapy in India

The company announced that India will be the first country among Glenmark's licensed markets to begin patient enrolment for the Phase 3 trial following approval from the Drugs Controller General of India (DCGI). Glenmark also plans to expand enrolment to Australia and South Korea, subject to regulatory approvals.

The randomized, controlled, multi-centre Phase 3 study is aligned with Jiangsu Hengrui Pharmaceuticals Co. Ltd.'s ongoing parent Phase 3 trial in China. It 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 disease with limited treatment options and poor clinical outcomes.

According to the company, conducting the trial across multiple geographies is expected to generate clinical evidence from diverse patient populations and strengthen the overall data package supporting the therapy across Glenmark's licensed markets.

Commenting on the development, 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."

The company noted that ovarian cancer remains one of the most challenging gynaecological malignancies worldwide, with India accounting for a significant share of global cases and deaths. Many patients treated with platinum-based chemotherapy eventually develop recurrence and platinum resistance, highlighting the need for more effective targeted therapies.

Glenmark entered into an exclusive collaboration and licensing agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd. in September 2025 to develop and commercialise Trastuzumab rezetecan across multiple international markets. Under the agreement, Glenmark holds exclusive commercialisation rights in several regions outside China and other specified territories.

Trastuzumab rezetecan is a first-in-class HER2-targeted antibody-drug conjugate developed by Hengrui Pharma for the treatment of HER2-overexpressing cancers. The therapy received conditional approval in China in May 2025 for HER2-mutated non-small cell lung cancer and was subsequently approved in March 2026 for second-line treatment of HER2-positive breast cancer. Hengrui has also filed a biologics licence application for its use in advanced colorectal cancer, while the therapy has received the National Medical Products Administration's (NMPA) Breakthrough Therapy Designation for nine indications across multiple tumour types.