Ivonescimab + platinum-doublet chemotherapy
EGFR-mutated non-squamous non-small cell lung cancer after EGFR TKI therapy · Patients with locally advanced or metastatic EGFR-mutated non-squamous NSCLC previously treated with a third-generation EGFR tyrosine kinase inhibitor
SMMT · Summit Therapeutics
Regulatory designations
Full timeline
5 milestonesFDA decision expected
FDA assigned a November 14, 2026 PDUFA goal action date to the ivonescimab combination BLA.
Summit — BLA acceptance and PDUFA date↗FDA accepted the BLA for filing
FDA accepted the application based on the global Phase 3 HARMONi study in EGFR-mutated locally advanced or metastatic non-squamous NSCLC after third-generation EGFR TKI therapy.
Summit — BLA acceptance↗Detailed HARMONi results were presented
Ivonescimab plus chemotherapy reduced the risk of progression or death versus chemotherapy alone, with a progression-free-survival hazard ratio of 0.52 at the prespecified primary analysis.
Summit — Detailed global Phase 3 HARMONi results↗FDA granted Fast Track designation
FDA granted Fast Track designation for ivonescimab plus platinum-based chemotherapy in the post-EGFR-TKI EGFR-mutated NSCLC setting.
Summit — Fast Track designation and HARMONi enrollment↗Related News
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