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Ivonescimab Plus Chemotherapy Shows Consistent, Favorable Overall Survival Results in Western and Asian Patients in Updated Analysis from Global Phase III HARMONi Study

SMMT
  • Summit Therapeutics announced updated overall survival (OS) results from the global Phase III HARMONi trial for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients previously treated with third-generation TKI.
  • Western patients achieved an OS hazard ratio (HR) of 0.76 in the June 2026 data cut, consistent with efficacy observed in Asian patients.
  • The June 2026 analysis included a median follow-up of 23.2 months for Western patients, compared to 32.7 months for Asian patients.
  • Prior analyses showed Western OS HRs of 0.98 in April 2025 and 0.84 in September 2025 as follow-up time increased.
  • The study demonstrated a statistically significant benefit in progression-free survival (PFS), one of the two primary endpoints.
  • Ivonescimab maintained an acceptable and manageable safety profile with no new safety signals noted in the latest data cut.
  • Summit submitted a Biologics License Application (BLA) to the FDA, which was accepted for filing in January 2026.
  • The Prescription Drug User Fee Act (PDUFA) goal action date for the BLA is set for November 14, 2026.
  • Updated analysis data have been made available to the FDA for review.
  • Additional detailed data from the June 2026 analysis are intended to be presented at an upcoming medical meeting.
  • Ivonescimab is a first-in-class investigational bispecific antibody targeting PD-1 and VEGF, developed by Akeso Inc.
  • Over 4,000 patients have been treated with ivonescimab in global clinical studies, with over 70,000 treated commercially in China.
  • The HARMONi trial compares ivonescimab plus chemotherapy against placebo plus chemotherapy in patients with locally advanced or metastatic non-squamous NSCLC.
  • Summit is conducting multiple Phase III trials including HARMONi-3, HARMONi-7, HARMONi-GI3, and ILLUMINE.
  • Ivonescimab was initially approved in China in May 2024 but remains investigational in Summit's license territories including the U.S. and Europe.