{"entity":{"id":"harmoni-a","kind":"trial","name":"HARMONi-A","aka":[],"tldr":"The first phase 3 win for ivonescimab, in lung cancer that has stopped responding to EGFR pills, and the basis of its first approval in China.","summary":"322 patients. Median progression-free survival 7.1 versus 4.8 months (hazard ratio 0.46) with benefit across subgroups including patients who had received third-generation EGFR inhibitors; published in JAMA in 2024. NMPA approval May 2024, the first for any PD-1 x VEGF bispecific antibody. Summit's global HARMONi trial in the same setting met progression-free survival but not overall survival at its 2025 analysis, the basis of a US filing with a November 2026 action date.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT05184712","url":"https://clinicaltrials.gov/study/NCT05184712"},{"label":"JAMA 2024","url":"https://doi.org/10.1001/jama.2024.10613"}],"tags":["china"],"related":["harmoni-2","harmoni-3"],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody"],"targets":["pd1","vegf","egfr"],"drugs":["ivonescimab","pemetrexed","carboplatin"],"companies":["akeso","summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["fang-wenfeng","zhang-li-sysucc","xia-michelle"],"bottlenecks":[],"keyPapers":["paper-harmoni-a-jama-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05184712","phase":"3","setting":"EGFR-mutant non-squamous NSCLC after progression on an EGFR TKI, China: ivonescimab or placebo plus pemetrexed and carboplatin","sponsor":"Akeso","result":"PFS 7.1 vs 4.8 months, HR 0.46.","started":"2022-01-25","startedType":"actual","yearReported":2024,"enrolled":322,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Ivonescimab + chemotherapy","n":161,"value":7.1},{"name":"Placebo + chemotherapy","n":161,"value":4.8}],"hr":0.46,"source":"https://doi.org/10.1001/jama.2024.10613"}]},"route":"/trials/harmoni-a/","neighbours":{"trial":[{"id":"harmoni-2","kind":"trial","name":"HARMONi-2","route":"/trials/harmoni-2/"},{"id":"harmoni-3","kind":"trial","name":"HARMONi-3","route":"/trials/harmoni-3/"}],"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/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"ivonescimab","kind":"drug","name":"Ivonescimab","route":"/drugs/ivonescimab/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"akeso","kind":"company","name":"Akeso","route":"/companies/akeso/"},{"id":"summit-therapeutics","kind":"company","name":"Summit Therapeutics","route":"/companies/summit-therapeutics/"}],"person":[{"id":"zhang-li-sysucc","kind":"person","name":"Li Zhang","route":"/people/zhang-li-sysucc/"},{"id":"xia-michelle","kind":"person","name":"Michelle Xia (Xia Yu)","route":"/people/xia-michelle/"},{"id":"fang-wenfeng","kind":"person","name":"Wenfeng Fang","route":"/people/fang-wenfeng/"}],"paper":[{"id":"paper-harmoni-a-jama-2024","kind":"paper","name":"Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial","route":"/key-papers/paper-harmoni-a-jama-2024/"}]}}