Merck Initiates Phase 3 Trial for Metastatic Breast Cancer Treatment

Wednesday, Aug 27, 2025 7:31 am ET1min read
MRK--

Merck has dosed the first patient in its Phase 3 trial for a metastatic breast cancer treatment. The trial aims to evaluate the efficacy and safety of the treatment in patients with HER2-positive metastatic breast cancer. Merck is a leading pharmaceutical company with a diverse portfolio of therapeutic products and vaccines.

Merck, a leading pharmaceutical company, has initiated the first patient dosing in its Phase 3 clinical trial, HERTHENA-Breast04, to evaluate the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with HER2-positive metastatic breast cancer. The trial aims to assess the investigational drug's potential as a new treatment option for this challenging type of breast cancer.

The HERTHENA-Breast04 trial is an open-label, randomized, Phase 3 study comparing patritumab deruxtecan monotherapy with physician's choice of treatment. Patients will be randomized 1:1 to receive either patritumab deruxtecan or standard treatment options, including chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, liposomal doxorubicin) or HER2-directed ADC (trastuzumab deruxtecan). The primary endpoints of the trial are progression-free survival and overall survival, with secondary endpoints including objective response rate, duration of response, and safety.

Merck's commitment to advancing innovative cancer treatments is evident in this trial. The company, known as MSD outside the United States and Canada, has a robust pipeline of more than 25 novel mechanisms, with a focus on addressing high unmet medical needs. This trial builds on the promising results from earlier phase studies, including ICARUS-Breast01, which demonstrated the potential of patritumab deruxtecan in patients with metastatic breast cancer.

The trial is enrolling approximately 1,000 patients across Asia, Europe, North America, and South America. For more information, please visit ClinicalTrials.gov.

References:

[1] https://www.stocktitan.net/news/MRK/herthena-breast04-phase-3-trial-of-patritumab-deruxtecan-initiated-r5rof1c1t9d5.html

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