Merck begins dosing patients in HERTHENA-Breast04 trial for patritumab deruxtecan in HER2-negative breast cancer.

Merck has dosed the first patient in the HERTHENA-Breast04 trial evaluating the efficacy and safety of patritumab deruxtecan in patients with unresectable locally advanced or metastatic hormone receptor positive, HER2 negative breast cancer. The trial compares patritumab deruxtecan to investigator's choice of treatment in patients with disease progression following endocrine and CDK4/6 inhibitor therapy. Patritumab deruxtecan is a HER3 directed DXd antibody drug conjugate being jointly developed by Daiichi Sankyo and Merck.

Merck has dosed the first patient in the HERTHENA-Breast04 trial, an open-label, randomized, phase 3 study evaluating the efficacy and safety of patritumab deruxtecan in patients with unresectable locally advanced or metastatic hormone receptor positive, HER2 negative breast cancer. The trial compares patritumab deruxtecan to investigator's choice of treatment in patients with disease progression following endocrine and CDK4/6 inhibitor therapy [1].

Patritumab deruxtecan is a HER3 directed DXd antibody drug conjugate being jointly developed by Daiichi Sankyo and Merck. The trial aims to assess the dual primary endpoints of progression-free survival and overall survival, as well as secondary endpoints such as objective response rate, duration of response, and safety. The study will enroll approximately 1,000 patients across Asia, Europe, North America, and South America [1].

The HERTHENA-Breast04 trial builds upon promising results from the ICARUS-Breast01 study and a phase 1/2 breast cancer trial published in the Journal of Clinical Oncology in June 2022, where patritumab deruxtecan demonstrated clinical activity in patients with metastatic breast cancer [1].

The initiation of HERTHENA-Breast04 reflects Merck's commitment to researching innovative approaches to treat challenging cancers. The trial is part of a broader global clinical development program evaluating the efficacy and safety of patritumab deruxtecan across multiple cancers, including combination therapies with other anticancer medicines [1].

References:
[1] https://www.marketscreener.com/news/herthena-breast04-phase-3-trial-of-patritumab-deruxtecan-initiated-in-patients-with-metastatic-hormo-ce7c50dedd8bf726