Loading
The global test of whether ivonescimab plus chemotherapy beats the Keytruda-chemotherapy standard. An interim look in May 2026 fell short on progression; final results are due later in 2026.
Interim analysis (May 2026) did not reach statistical significance for PFS; the company expects final PFS and interim OS readouts in 2026. The FDA has set a PDUFA date of 14 November 2026 for a separate BLA based on HARMONi (EGFR-mutant, post-TKI), where the Western-subgroup OS hazard ratio improved to 0.76 without statistical significance.
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.
1,080 enrolled.
Interim PFS analysis did not reach statistical significance per the sponsor (announced 30 April 2026); hazard ratio and medians not disclosed. Final PFS and OS analyses pending.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (interim analysis, May 2026)primary | Ivonescimab + chemotherapy | - | Interim PFS analysis did not reach statistical significance per the sponsor (announced 30 April 2026); hazard ratio and medians not disclosed. Final PFS and OS analyses pending. | - | - | link |
| Pembrolizumab + chemotherapy | - | - |
Shares Summit Therapeutics, Ivonescimab, PD-L1-high non-small-cell lung cancer without a driver mutation, Bispecific antibodies.
Shares Summit Therapeutics, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares Summit Therapeutics, Ivonescimab, Bispecific antibodies, Pembrolizumab.
Shares HARMONi-A, Ivonescimab, PD-L1-high non-small-cell lung cancer without a driver mutation, Bispecific antibodies.
Shares Summit Therapeutics, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares Summit Therapeutics, Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors.
Shares PD-L1-high non-small-cell lung cancer without a driver mutation, Pembrolizumab, Immune checkpoint inhibitors, Non-small-cell lung cancer.
Shares Ivonescimab, Bispecific antibodies, Immune checkpoint inhibitors, Non-small-cell lung cancer.