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The first head-to-head trial in which a new drug beat Keytruda, in China; a survival benefit followed in 2026.
HARMONi-2, trial NCT05499390 sponsored by Akeso and reported in 2024, was the first head-to-head trial in which a new drug beat pembrolizumab, comparing the PD-1 by VEGF bispecific ivonescimab with pembrolizumab as first-line monotherapy for PD-L1-positive advanced non-small-cell lung cancer in China. It randomised 398 patients, met its primary progression-free survival endpoint by independent review with a substantial improvement, and in 2026 Akeso and Summit reported a statistically significant overall survival benefit. OnCo links it to PD-1 and VEGF as targets, to Michelle Xia, Qing Zhou and Caicun Zhou, and to HARMONi-A. It was a single-country trial and the global HARMONi-3 interim analysis did not reproduce the progression-free survival margin, so whether Western regulators accept the result rests on HARMONi-3 and HARMONi-7. Ivonescimab has its own page.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
398 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (IRRC)primary | Ivonescimab | 198 | 11.1 months | 0.51 (0.38 to 0.69) | <0.0001 | link |
| Pembrolizumab | 200 | 5.8 months |
Shares HARMONi-A, Ivonescimab, PD-L1-high non-small-cell lung cancer without a driver mutation, Bispecific antibodies.
Shares HARMONi-A, Akeso, Ivonescimab, VEGF / VEGFR.
Shares Ivonescimab, PD-L1-high non-small-cell lung cancer without a driver mutation, Bispecific antibodies, Pembrolizumab.
Shares Akeso, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares Akeso, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares Akeso, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares Akeso, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares Akeso, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.