Glenmark Advances Multi-Country Phase 3 Trial for Ovarian Cancer Drug

Glenmark Specialty S.A., a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811). This HER2-targeted antibody drug conjugate (ADC) is being developed for patients with platinum-resistant ovarian cancer (PROC). India will be the first country within Glenmark's licensed markets to initiate patient enrollment for this trial, following approval from the Drugs Controller General of India (DCGI).

Key highlights

• Glenmark Specialty S.A. advanced its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811).
• The drug is a HER2-targeted antibody drug conjugate (ADC) designed for platinum-resistant ovarian cancer (PROC).
• India has become the first country in Glenmark’s licensed markets to receive regulatory approval and will initiate patient enrollment for the Phase 3 trial.
• Glenmark plans to enroll additional patients in Australia and South Korea, subject to respective regulatory approvals.
• The study aligns with Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s ongoing parent Phase 3 trial in China.

What drove it

Glenmark's objective for this multi-country trial is to generate clinically relevant data across broader and more diverse patient populations. This data is intended to support the development of Trastuzumab rezetecan across Glenmark's licensed markets. The company highlighted that platinum-resistant ovarian cancer remains an area with significant unmet medical need, limited treatment options, and poor patient outcomes.

Context

In September 2025, Glenmark entered an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. for Trastuzumab rezetecan, securing rights to develop and commercialize the asset in multiple markets. The drug was conditionally approved in China in May 2025 for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have received at least one prior systemic therapy. This marked the first China-developed ADC approved for HER2-mutated NSCLC.

Why it matters

Advancing this pivotal Phase 3 trial represents a significant step in Glenmark's efforts to build a differentiated oncology pipeline for global markets. Platinum-resistant ovarian cancer presents a challenging medical condition with limited effective treatments. By initiating patient enrollment in India and planning for other countries, Glenmark aims to generate evidence from diverse patient groups, strengthening the clinical data package for this therapy. This development could potentially offer a new targeted treatment option for patients grappling with this difficult-to-treat cancer, given that ovarian cancer is among the most common cancers affecting women globally, with India bearing a substantial burden.

What to watch

Continued progress on patient enrollment across the planned geographies will be closely monitored. Further regulatory approvals in Australia and South Korea for trial commencement will also be key developments to observe. (Source: Exchange filing NSE 106684024)