Akeso builds up its ivonescimab ambitions again

Is there anything ivonescimab can’t do? Its originator, Akeso, doesn’t seem to think so, recently pushing the PD-1 x VEGF bispecific into pivotal development in first-line biliary tract cancer, a new listing on the clinicaltrials.gov registry reveals. This niche features two approved checkpoint inhibitors, Merck’s Keytruda and AstraZeneca’s Imfinzi, although Imfinzi appears to have the edge. Akeso has plumped for the tougher comparator, and the bar to clear is a 12.9-month median overall survival, 7.2-month median PFS and 27% ORR, seen in the Topaz-1 study of Imfinzi plus chemo. Ivonescimab has already claimed a win over Keytruda in first-line NSCLC, and recently showed promise at ESMO in untreated triple-negative breast and colorectal cancers; in the latter the best results came from a combination with the anti-CD47 MAb ligufalimab. The group’s US partner, Summit Therapeutics, is focused on NSCLC for now, with Harmoni and Harmoni-3 ongoing, and Harmoni-7 slated to start next year, testing ivonescimab versus Keytruda in PD-L1-high front-line disease. Akeso appears to have broader plans; it just started a pivotal trial of ivonescimab plus ligufalimab in head and neck cancer, and in August said it was planning a phase 3 in first-line pancreatic cancer.

Ivonescimab’s phase 3 trials

Note: BTC=biliary tract cancer; HNSCC=head and neck squamous cell carcinoma. Source: OncologyPipeline.

The Harmoni-A data in this story have been updated.