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Promising Early Results For AZ And Daiichi’s Dato-DXd In Breast Cancer – But How Soon Can They File?

Partners Keen To Take On Gilead’s Trodelvy

 
• By Andrew McConaghie

Once again choosing their words carefully, the partners talk only of ‘plans’ to file as regulators will first have to clarify when overall survival data will be required for the new antibody-drug conjugate in breast cancer.

China Beijing Ciftis
AZ and Daiichi Sankyo hope that Dato-DXd can follow in the footsteps of their other ADC, Enhertu, and become an oncology blockbuster. • Source: Shutterstock

AstraZeneca and Daiichi Sankyo will talk to regulators about their promising new Phase III results for datopotamab deruxtecan (Dato-DXd) in the most common form of advanced breast cancer – but may have to hold on for overall survival results before filing.

The companies have revealed that the TROP2-targeted antibody-drug conjugate (ADC) hit its primary endpoint of progression-free survival (PFS) in the TROPION-Breast01 study, and described the result as a “statistically significant...

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