HARMONi-3
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.
Setting
First-line metastatic squamous and non-squamous NSCLC, global: ivonescimab + chemotherapy vs pembrolizumab + chemotherapy
Phase
Phase 3
Sponsor
Summit Therapeutics
Registry
Headline result
Interim PFS not statistically significant (May 2026); final readouts pending.
Reported
2026
Enrolled
1080
Replication
Ongoing; interim PFS analysis in 2026 did not meet significance per the sponsor; OS pending.