Summit takes on Keytruda again

Summit will again pit its Akeso-originated anti-VEGF x PD-1 MAb ivonescimab against Merck & Co's Keytruda in lung cancer, a new clinicaltrials.gov listing has revealed. The phase 3 Harmoni-7 study will enrol PD-L1-high patients, and test OS and PFS as co-primary endpoints; the respective benchmarks for medians here are 26.3 months and 10.3 months in the Keynote-024 trial. Ivonescimab's chemo combo is already in the front-line Harmoni-3 trial in NSCLC patients with any level of PD-L1 expression; the Chinese, Akeso-sponsored Harmoni-2 study in a similar setting, but testing monotherapy, impressed at last year's World Lung conference – with caveats. Akeso has separately initiated a pivotal trial testing ivonescimab plus chemo in triple-negative breast cancer, but Summit isn't active here. VEGF x PD-(L)1 bispecifics continue to generate deal interest, and Innolake Biopharm's ILB-2201 has emerged as a recent entrant. Instil Bio, a separate player that licensed IMM2510/SYN-2510 from ImmuneOnco, this week said it was hoping to take this project's chemo combo into a first-line NSCLC study this year. This will be driven by ImmuneOnco's recently initiated Chinese phase 1/2 study, which includes front-line patients and is expected to yield data "as soon as the second half of 2025".

Pivotal trials of ivonescimab in NSCLC

Source: OncologyPipeline.