Daiichi Sankyo Launches Phase III Trial of DS-8201a 100mg Injection for HER2-Expressing Endometrial Cancer

Drug Clinical Trial Registration Information Shows That Daiichi Sankyo, Inc./DAIICHI SANKYO (CHINA) HOLDINGS CO., LTD./Baxter Oncology GmbH's DS-8201a 100mg Injection, a Phase III, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard Chemotherapy as Adjuvant Treatment (With or Without Radiation Therapy) for HER2-Expressing (IHC 3+/2+) Endometrial Cancer, Has Been Initiated. The Clinical Trial Registration Number is CTR20253443, and the Initial Information Disclosure Date is August 26, 2025.

The drug formulation is a lyophilized powder, with a dosage of 5.4 mg/kg administered via intravenous infusion, and a dosing schedule of Q3W. The primary objective of this trial is to evaluate the efficacy and safety of T-DXd compared to SoC chemotherapy as adjuvant therapy (with or without radiotherapy) for participants with HER2-expressing (IHC 3+/2+) endometrial cancer.

DS-8201a 100mg Injection is a biologic product, indicated for endometrial cancer. Endometrial cancer is a group of epithelial malignant tumors occurring in the endometrium, with main symptoms including vaginal bleeding and discharge. Diagnosis mainly relies on ultrasound, hysteroscopy, and pathological examination.

The primary endpoint of this trial includes disease-free survival as assessed by BICR or histopathological confirmation of disease recurrence (according to local evaluation); secondary endpoints include overall survival.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 130 participants in China and 710 participants internationally.

Risk Warning: The market involves risks, and investments should be made with caution. This article is automatically published by an AI model based on a third-party database. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is for reference only and does not constitute personal investment advice. Due to issues such as the quality of the third-party database, we are unable to verify or ensure the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information. Please refer to official company announcements for specific details. If you have any questions, please contact biz@staff.sina.com.cn.

Editor: Xiaolang Express