Not so fast for Astra in bladder cancer

With the shock withdrawal of a US lung cancer filing for AstraZeneca/Daiichi Sankyo's datopotamab deruxtecan seizing the limelight this week, a couple of minor delays to another Astra drug, Imfinzi, largely went unnoticed. But they relate to bladder cancer, a space in which Astra has big plans after this year's success of Niagara, claimed to be the first trial of an immunotherapy before and after surgery to extend survival in this cancer. Astra has slipped out the quiet delays of two other bladder cancer studies, Nile and Potomac, whose readouts are now expected in the second half of next year, rather than late 2024/early 2025. Nile seems especially problematic, still using chemo as the comparator in a first-line setting that has recently seen Padcev plus Keytruda (and to a lesser extent Opdivo plus chemo) emerge as practice-changing options. A filing based on Nile had initially been targeted for 2021, but extensive delays followed, with primary endpoints and enrolment targets changed. As for Niagara, Astra revealed this week that an EU filing had been made, but there is still no news about an FDA submission.

Selected Imfinzi trials in bladder cancer

Source: OncologyPipeline & Astra disclosures.