Astra's next wave goes beyond subcutaneous Imfinzi

Those wondering why AstraZeneca appears to be dragging its feet on developing a subcutaneous Imfinzi formulation got some clarity today, with the group playing down the importance of this as a franchise-protecting strategy. Instead, executives told this morning’s fourth-quarter press conference that the big opportunity was to replace PD-(L)1 with the next wave of immuno-oncology, specifically highlighting its bispecifics volrustomig (PD-1 x CTLA-4) and rilvegostomig (PD-1 x TIGIT), which recently entered large pivotal programmes. “We see that as the opportunity to really move the bar,” said Dave Fredrickson, executive vice-president of Astra’s oncology business. With Merck & Co’s Keytruda coming off patent in 2028, Roche, Bristol and Merck itself have been pressing ahead with subcutaneous PD-(L)1 MAb formulations, but an IV bispecific approach incorporating PD-1 blockade could serve a similar purpose for Astra’s franchise, assuming it succeeds clinically. Separately, Susan Galbraith, Astra’s head of oncology R&D, said subcutaneous delivery mostly had patient convenience advantages, adding that Astra was investing in subcutaneous formulations generally, including for complex biologicals and not just for anti-PD-1. The 18-patient Scope-D1 study of SC Imfinzi ended last August, and Astra reiterated today that data from it wouldn’t come until the second half.