Akeso IncAkeso's partner trial of ivonescimab showed statistically significant survival benefit versus Keytruda in advanced NSCLC.
Summit Therapeutics said Sunday that its ivonescimab significantly extended survival compared with Merck's Keytruda in a late-stage lung cancer trial run by its partner Akeso in China. Ivonescimab reduced the risk of death by 27% versus Keytruda, also known as pembrolizumab, in previously untreated patients with advanced non-small cell lung cancer whose tumors expressed PD-L1, with median overall survival of 30.8 months against 22.6 months, an 8.2-month difference Summit called statistically significant. The Phase 3 HARMONi-2 trial enrolled 398 patients with a median follow-up of 36 months, and the results are being presented at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer in Seoul. In the 168-patient subgroup with high PD-L1 expression, ivonescimab cut the risk of death by 42%, while the benefit was smaller and not statistically reliable in patients with lower PD-L1 expression, where the hazard ratio was 0.85 with a confidence interval crossing 1.0. Serious treatment-related adverse events occurred in 29.9% of ivonescimab patients versus 21.6% for Keytruda, though discontinuations were slightly less frequent at 4.1% versus 5%, and Summit is now recruiting for the global Phase 3 HARMONi-7 trial, expected to enroll 780 patients, while the FDA reviews a separate application in previously treated EGFR-mutated lung cancer with a Nov. 14 decision deadline.
Akeso IncAkeso's partner trial of ivonescimab showed statistically significant survival benefit versus Keytruda in advanced NSCLC.
Merck & Company IncIvonescimab beat Merck's Keytruda with a 27% reduction in death risk and 8.2-month overall survival advantage in the HARMONi-2 trial.
Summit Therapeutics PLC
Merck KGaA