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), 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. Ltd.'s ongoing parent Phase 3 trial in China. 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.
This initiative 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 trial addresses platinum-resistant ovarian cancer, described as a difficult-to-treat disease where treatment options remain limited and outcomes continue to be poor.
Background and Context
In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. for Trastuzumab rezetecan (SHR-A1811), securing rights to develop and commercialize the asset across multiple markets. Under the agreement, Glenmark holds exclusive rights worldwide excluding Mainland China, the Hong Kong SAR, the Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan.
About Trastuzumab Rezetecan
Trastuzumab rezetecan (SHR-A1811) is a HER2-targeted first-in-class antibody-drug conjugate developed by Hengrui Pharma. It has received conditional approval in China (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.
The drug received marketing authorization for HER2-positive second-line breast cancer in March 2026 after priority review designation. In February 2026, Hengrui Pharma filed a biologics license application for the treatment of HER2 positive advanced colorectal cancer.
To date, Trastuzumab rezetecan has been included in the NMPA's Breakthrough Therapy Designation list for nine indications, covering NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.
Medical Context
Ovarian cancer is described as the eighth most common cancer among women worldwide, with India carrying a significant burden and ranking among countries with the highest number of ovarian cancer cases and deaths globally. Many patients with advanced ovarian cancer treated with available platinum-based therapies develop recurrence and subsequently platinum resistance.
Management Commentary
Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited, stated: "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."