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. In this niche two checkpoint inhibitors are approved: 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 also said in August that it's 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.