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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

TrialSettingDesignTimeline
NiagaraPerioperative bladder cancerImfinzi + chemo (neoadjuvant), then Imfinzi (adjuvant), vs chemoPositive data presented at ESMO 2024; filed in EU (decision expected in H2 2025); as of Nov 2024 no US filing has been submitted
Nile1L metastatic bladder cancerImfinzi + chemo +/- Imjudo, vs chemoFiling initially planned in 2021; enrolment target changed from 885 to 1,434, to 1,292, to 1,246 patients; PFS relegated to secondary endpoint (OS sole primary); readout delayed from 2022 to H2 2024, to H2 2025
PotomacNMIBCImfinzi + BCG, vs BCGEnrolment target changed from 975 to 1,018 patients; readout delayed from H1 2025 to H2 2025
Volga1L cisplatin-ineligible MIBCImfinzi + Padcev +/- Imjudo, vs radical cystectomyEnrolment target changed from 1,080 to 677 patients; readout due H2 2025 (no change)

Source: OncologyPipeline & Astra disclosures.

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