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
Trial | Sponsor/location | Setting | Regimen | Comparator | Note |
---|---|---|---|---|---|
Harmoni-A | Akeso, China | 2nd-line NSCLC | Ivonescimab + chemo | Chemo | Data ASCO 2024: ORR 51% vs 35%, PFS 7.1 vs 4.8mo; OS 17.1 vs 14.5mo |
Harmoni-2 | Akeso, China | 1st-line NSCLC, PD-L1 ≥1% | Ivonescimab | Keytruda | Data World Lung 2024: ORR 50% vs 39%; PFS 11.1 vs 5.8mo |
AK112-306 | Akeso, China | 1st-line squamous NSCLC | Ivonescimab + chemo | Tislelizumab + chemo | Primary completion Dec 2024 |
Harmoni | Summit, global | 2nd-line NSCLC | Ivonescimab + chemo | Chemo | Primary completion Dec 2025 |
Harmoni-3 | Summit, N America | 1st-line NSCLC, PD-L1+ve | Ivonescimab | Keytruda | Primary completion Sep 2027 |
AK117-302 | Akeso, China | 1st-line HNSCC | Ivonescimab + ligufalimab | Keytruda | Primary completion Jan 2027 |
AK112-309 | Akeso, China | First-line BTC | Ivonescimab + chemo | Imfinzi + chemo | Primary completion Jul 2027 |
Note: BTC=biliary tract cancer; HNSCC=head and neck squamous cell carcinoma. Source: OncologyPipeline.
The Harmoni-A data in this story have been updated.
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