{"entity":{"id":"harmoni-3","kind":"trial","name":"HARMONi-3","aka":[],"tldr":"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.","summary":"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.","status":"mixed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05899608","url":"https://clinicaltrials.gov/study/NCT05899608"},{"label":"Fierce Pharma on HARMONi OS update","url":"https://www.fiercepharma.com/pharma/summit-therapeutics-updates-ivonescimab-survival-data-ahead-fda-decision-date"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","pembrolizumab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05899608","phase":"3","setting":"First-line metastatic squamous and non-squamous NSCLC, global: ivonescimab + chemotherapy vs pembrolizumab + chemotherapy","sponsor":"Summit Therapeutics","result":"Interim PFS not statistically significant (May 2026); final readouts pending.","started":"2023-10-26","startedType":"actual","yearReported":2026,"enrolled":1080,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (interim analysis, May 2026)","primary":true,"unit":"months","arms":[{"name":"Ivonescimab + chemotherapy","note":"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."},{"name":"Pembrolizumab + chemotherapy"}],"source":"https://clinicaltrials.gov/study/NCT05899608"}],"replication":"Ongoing; interim PFS analysis in 2026 did not meet significance per the sponsor; OS pending."},"route":"/trials/harmoni-3/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"ivonescimab","kind":"drug","name":"Ivonescimab","route":"/drugs/ivonescimab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"summit-therapeutics","kind":"company","name":"Summit Therapeutics","route":"/companies/summit-therapeutics/"}],"idea":[{"id":"idea-tr1-low-dose-immunotherapy-for-lmic","kind":"idea","name":"Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live","route":"/ideas/idea-tr1-low-dose-immunotherapy-for-lmic/"}],"trial":[{"id":"harmoni-a","kind":"trial","name":"HARMONi-A","route":"/trials/harmoni-a/"}]}}