AstraZeneca goes early with new datopotamab breast phase 3s

AstraZeneca and Daiichi’s anti-TROP2 ADC datopotamab deruxtecan looks better in breast than lung cancer, based on data just presented at ESMO. Now Astra has disclosed at an investor event plans to go into early triple-negative disease, where it will be trying to tackle Merck & Co’s Keytruda by combining dato with its own checkpoint inhibitor, Imfinzi. The Tropion-Breast04 study in stage II-III disease will compare neoadjuvant dato plus Imfinzi, followed by adjuvant Imfinzi plus chemo, versus neoadjuvant then adjuvant Keytruda plus chemo. Primary endpoints are pathological complete response and event-free survival. Meanwhile, the first-line Tropion-Breast05 is testing dato, either alone or in combination with Imfinzi, versus Keytruda plus chemo, with a primary endpoint of progression-free survival. This study will enrol PD-L1-positive patients, defined as those with a combined positive score of 10 or more – the same population in which Keytruda is approved in first-line TNBC. Astra already has a first-line TNBC phase 3 trial of dato under way, Tropion-Breast02, in patients who can’t receive checkpoint inhibitors. Meanwhile, the ongoing Tropion-Breast03 in stage I-III disease tests dato with or without Imfinzi versus standard of care, which can – but does not have to – include Keytruda.

AstraZeneca’s recently disclosed datopotamab deruxtecan phase 3 trial starts

CPS=combined positive score. Source: Company presentation.