Akeso and Summit Therapeutics’ ivonescimab has shown further benefit in a first-line non-small cell lung cancer (NSCLC) Phase III study, meeting the key secondary overall survival (OS) endpoint.
In the randomised, double-blind, multicentre HARMONi-2 trial (NCT05499390), pre-specified interim analysis of OS, as assessed by the Independent Data Monitoring Committee (IDMC), indicated that ivonescimab led to both statistically and clinically meaningful improvement over MSD’s Keytruda (pembrolizumab).
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This follows earlier data, at a May 2024 cutoff, from the China-based study in which patients treated with ivonescimab reported a median progression-free survival (PFS) of 11.14 months versus 5.82 months for Keytruda.
The first-in-class PD-1/VEGF bispecific antibody was pitted against Keytruda as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 (TPS ≥1%).
While Akeso and Summit have not yet released OS data, Citi and Evercore analysts believe the OS benefit will be stronger than 30%.
Dr Yu Xia, president and CEO of Akeso, said: “We are pleased that the fourth Phase III study of an ivonescimab-based regimen has now demonstrated statistically significant benefit in both OS and PFS. These results further reinforce the clinical value of ivonescimab in the treatment of lung cancer.
To date, ivonescimab has achieved dual positive OS and PFS outcomes across multiple Phase III head-to-head trials versus PD-1/PD-L1 therapies. This growing body of evidence strengthens our confidence in its potential across a broader range of solid tumours. With its unique dual mechanism of action combining immunotherapy and anti-angiogenesis, we believe ivonescimab offers a more effective treatment option for patients and will contribute meaningfully to the evolving oncology treatment landscape.”
Akeso said that HARMONi-2 is the first Phase III RCT to show a significant positive outcome against Keytruda in this setting. Detailed data from the interim OS analysis will be presented at an upcoming international medical conference and published in a peer-reviewed journal.
The drug is also being investigated in a Phase III trial in patients with PD‑L1 high‑expressing NSCLC (HARMONi-7/ AK112-3007).
Beyond the HARMONi-2 trial, other Phase III studies of the drug have also met goals. In August 2026, Akeso and Summit announced data from the HARMONi-GI1 study (NCT06591520) in patients with advanced biliary tract cancer (BTC), which achieved its OS goal.
In May 2024, the drug first received Chinese approval in NSCLC; however, a US decision on the drug in the same indication is currently under review, with a Prescription Drug User Fee Act (PDUFA) date of 14 November.
The drug’s success will be welcome news for Summit, which pledged up to $5bn to Akeso to secure the rights to ivonescimab in the US, Europe, Canada, Japan, Latin America, the Middle East and Africa back in 2022.
According to a consensus forecast from GlobalData, the parent company of Clinical Trials Arena, ivonescimab will approach mega-blockbuster status in 2032 by bringing in more than $9bn in sales.
GlobalData is the parent company of Clinical Trials Arena.
