Glenmark Advances Phase 3 Trial of Trastuzumab Rezetecan in Platinum-Resistant Ovarian Cancer Following DCGI Approval
核心洞察
Glenmark Specialty S.A. has advanced its multi-country Phase 3 clinical trial of trastuzumab rezetecan (SHR-A1811), a HER2 (搜索)-targeted antibody-drug conjugate, for patients with platinum-resistant ovarian cancer (搜索).
India becomes the first country in Glenmark's licensed markets to initiate patient enrollment following approval from the Drugs Controller General of India, with Australia and South Korea planned next.
The randomized, controlled, multi-centre trial will evaluate efficacy, safety, and pharmacokinetics in HER2 (搜索)-expressing platinum-resistant ovarian cancer (搜索), a disease with limited treatment options and poor outcomes.
Glenmark Specialty S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., has advanced its multi-country Phase 3 clinical trial for trastuzumab rezetecan (SHR-A1811), a HER2 (搜索)-targeted antibody-drug conjugate (ADC), in patients with platinum-resistant ovarian cancer (搜索) (PROC). India has become the first country in Glenmark's licensed markets to initiate patient enrollment, following approval from the Drugs Controller General of India (DCGI). The company also plans to enroll patients in Australia and South Korea, subject to regulatory approvals in those markets.
The study is aligned with Jiangsu Hengrui Pharmaceuticals (搜索) Co. Ltd.'s ongoing parent Phase 3 trial in China, with Glenmark aiming to generate clinically relevant data across broader and more diverse patient populations to support the development of trastuzumab rezetecan across its licensed markets.
Trial Design and Objectives
The randomized, controlled, multi-centre Phase 3 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of trastuzumab rezetecan in patients with HER2 (搜索)-expressing platinum-resistant ovarian cancer (搜索). 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.
Dr. Monika Tandon, global head of clinical development at Glenmark Pharmaceuticals Limited, commented: "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 (搜索) 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."
Trastuzumab Rezetecan: A HER2 (搜索)-Targeted ADC with Expanding Indications
Trastuzumab rezetecan (SHR-A1811) is a HER2 (搜索)-targeted first-in-class antibody-drug conjugate developed by Hengrui Pharma. The drug addresses challenges posed by HER2-overexpressing tumors found in various cancer types, including breast, gastric, and colorectal cancers. The asset has achieved several key regulatory milestones: conditional approval in China in May 2025 for unresectable locally advanced or metastatic non-small cell lung cancer (搜索) (NSCLC) with HER2 activating mutations; priority review designation in September 2025 for a breast cancer (搜索) indication; a BLA filing in February 2026 for HER2-positive advanced colorectal cancer (搜索); and approval in March 2026 for HER2-positive second-line breast cancer.
To date, trastuzumab rezetecan has been included in China's NMPA Breakthrough Therapy Designation list for nine indications, covering NSCLC, breast cancer (搜索), gastric or gastroesophageal junction adenocarcinoma, colorectal cancer (搜索), biliary tract cancer, and gynecologic malignancies.
Addressing Unmet Need in Ovarian Cancer
Platinum-resistant ovarian cancer (搜索) remains a difficult-to-treat disease with limited treatment options and poor outcomes. Ovarian cancer is the eighth most common cancer among women worldwide, and India carries a significant burden, ranking among the countries with the highest number of ovarian cancer cases and deaths globally. Many patients treated with available platinum-based therapies develop recurrence and subsequent platinum resistance, underscoring the need for novel targeted therapies such as trastuzumab rezetecan.
Licensing and Collaboration Framework
In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals (搜索) Co., Ltd. for trastuzumab rezetecan (SHR-A1811). Under the agreement, Glenmark holds exclusive rights to develop and commercialize the asset 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.