AstraZeneca, Daiichi Sankyo’s ADC Flops in Phase III Breast Cancer on Heels of Lung Cancer Stumble

CAR-T Digest - August 2020

23 Sep 2024: AstraZeneca, Daiichi Sankyo’s ADC Flops in Phase III Breast Cancer on Heels of Lung Cancer Stumble

AstraZeneca and Daiichi Sankyo’s Dato-DXd missed its overall survival goal in the Phase III TROPION-Breast01 study, raising concerns about its efficacy
The companies did not provide specific survival figures, stating that the analysis did not achieve statistical significance
Despite the setback, AstraZeneca emphasized the clinical value of Dato-DXd in metastatic HR-positive breast cancer and plans to apply insights from the study for future development
The ADC is under FDA review, this could heighten current concerns regarding its chances of approval and possibly delay the PDUFA decision date (20 December, 2024)
Failure to improve overall survival complicates regulatory discussions and may lead to an advisory committee meeting for the NSCLC indication