Summit changes its tune again

Summit Therapeutics has tinkered with the first-line Harmoni-3 trial of its Akeso-partnered PD-1 x VEGF project ivonescimab again to allow earlier results and, potentially, FDA approval. Last year the company opted to test the study’s PFS and OS co-primary endpoints in squamous and non-squamous patients separately – allowing a squamous readout in the second half of this year. Summit disclosed in its fourth-quarter results release on Monday that it had now amended the study to include an interim PFS analysis in squamous patients in the second quarter of 2026; OS is expected to be immature at this time. Evercore ISI’s Cory Kasimov noted that the latest move might enable a conversation with the FDA regarding approval based on PFS alone; however, he said he was sceptical about this plan, given that OS remains the gold standard endpoint. The final PFS analysis, and first interim OS analysis, are on track for the second half. Harmoni-3 tests ivonescimab plus chemo, versus Keytruda plus chemo. Enrolment into the non-squamous cohort, meanwhile, is expected to complete in the second half of 2026. Separately, Summit is awaiting an FDA decision on ivonescimab plus chemo in second-line NSCLC by 14 November, based on the Harmoni trial.