AstraZeneca: TROPION-Breast01 Phase III Trial Fails To Achieve Statistical Significance

(RTTNews) - AstraZeneca plc (AZN, AZN.L) announced on Monday that the high-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan or Dato-DXd compared to the investigator's choice of chemotherapy did not demonstrate statistical significance in the final overall survival analysis.

This trial included patients with inoperable or metastatic hormone receptor-positive, HER2-low, or negative breast cancer who had been previously treated with endocrine-based therapy and at least one systemic therapy. While the trial previously met the dual primary endpoint of progression-free survival or PFS, the final overall survival analysis did not achieve statistical significance.

The analysis follows the positive PFS results disclosed during the 2023 European Society for Medical Oncology Congress, demonstrating that datopotamab deruxtecan yielded a statistically significant and clinically relevant enhancement in PFS. Moreover, an amelioration in patient-reported outcomes was observed. The PFS data and supplementary findings for critical secondary endpoints have been recently published in the Journal of Clinical Oncology.

Datopotamab deruxtecan is a TROP2-directed DXd ADC engineered by Daiichi Sankyo and co-developed by AstraZeneca and Daiichi Sankyo. The data pertaining to this compound will be presented at an upcoming medical conference and shared with regulatory authorities currently assessing applications for this specific indication.

Apart from TROPION-Breast01, AstraZeneca and Daiichi Sankyo are conducting assessments of datopotamab deruxtecan as a standalone treatment and in combination with immunotherapy for patients with triple-negative or HR-low, HER2-negative breast cancers in the TROPION-Breast02, TROPION-Breast03, TROPION-Breast04, and TROPION-Breast05 Phase III trials.