Glenmark advances multi-country Phase 3 clinical trial for Trastuzumab rezetecan

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

India will serve as the first country in Glenmark's licensed markets to initiate patient enrollment for the Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). Glenmark also plans to enroll patients in Australia and South Korea, subject to regulatory approvals.

The study is aligned with Jiangsu Hengrui Pharmaceuticals Co.'s ongoing parent Phase 3 trial in China. Glenmark aims to generate clinically relevant data across broader and more diverse patient populations, supporting the development of Trastuzumab rezetecan across Glenmark's licensed markets. The randomized, controlled, multi-centre, Phase 3 trial 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 where treatment options remain limited, and outcomes continue to be poor. Conducting the trial across multiple geographies is expected to support the generation of evidence from diverse patient groups and strengthen the clinical data package for the therapy across Glenmark's licensed markets.