AstraZeneca and Daiichi Sankyo have reported results from the TROPION-Breast01 Phase III clinical trial of datopotamab deruxtecan (Dato-DXd) for breast cancer.
The trial compared Dato-DXd to the investigator's choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer.
These patients had previously undergone endocrine-based therapy and at least one other systemic therapy.
The trial, which previously met its primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis.
Despite not meeting the OS endpoint, the trial had earlier shown that Dato-DXd significantly improved PFS, which was both statistically significant and clinically meaningful.
Additionally, patients reported an improvement in their quality of life during the trial.
Datopotamab deruxtecan’s safety profile was found to be consistent with previous analyses.
Notably, it was associated with lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy.
Importantly, no new safety concerns were identified, and the rates of all-grade interstitial lung disease (ILD) remained low with no new Grade 3 or higher ILD events.
A TROP2-directed DXd ADC, Dato-DXd was discovered by Daiichi Sankyo and is being co-developed with AstraZeneca.
AstraZeneca oncology R&D executive vice-president Susan Galbraith said: “The metastatic HR-positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients.
“Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting. We will continue discussions with regulatory authorities and apply insights from these results to our clinical development programme for datopotamab deruxtecan in breast cancer.”
In May 2024, AstraZeneca and Daiichi Sankyo reported high-level overall survival (OS) results from the Phase III TROPION-Lung01 trial of Dato-DXd in patients with advanced nonsquamous non-small cell lung cancer.
