Topline Results from TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan
The TROPION-Breast01 phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd) against investigator’s choice chemotherapy has reported that while the treatment met its primary endpoint for progression-free survival (PFS), it did not achieve statistical significance for overall survival (OS) in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative breast cancer previously treated with endocrine therapies and systemic treatment.
Datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca, previously demonstrated significant PFS improvements presented at the 2023 European Society for Medical Oncology Congress. Positive patient-reported outcomes were also noted. Safety data confirmed that treatment-related adverse events were lower than those seen with chemotherapy, with no new concerns arising.
The landscape for treating metastatic HR positive breast cancer has evolved significantly, and the results suggest datopotamab deruxtecan’s potential clinical value. Ongoing discussions with regulatory authorities will focus on leveraging these findings in further development.
In addition to TROPION-Breast01, ongoing trials are assessing datopotamab deruxtecan in various settings, including triple-negative breast cancer.
About TROPION-Breast01
TROPION-Breast01 is a global phase 3 trial involving over 700 patients to evaluate the efficacy and safety of datopotamab deruxtecan versus single-agent chemotherapy in advanced HR positive, HER2 low or negative breast cancer.
About Datopotamab Deruxtecan
Datopotamab deruxtecan is an investigational ADC targeting TROP2, part of Daiichi Sankyo’s pipeline of innovative therapies for various cancers.
Collaboration Background
Daiichi Sankyo and AstraZeneca are collaborating on the development of datopotamab deruxtecan, with a commitment to bringing new treatment options to patients.
