Summit Therapeutics Inc. (NASDAQ:SMMT) on Wednesday shared updated overall survival (OS) data from its Phase 3 HARMONi study, evaluating the investigational bispecific antibody ivonescimab for treating specific forms of lung cancer.
The study is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy for endothelial growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI).
The latest analysis continues to demonstrate a favorable overall survival trend and a consistent safety profile across diverse patient populations.
Prolonged Follow-Up Enhances Efficacy Trends
The HARMONi trial investigates ivonescimab paired with chemotherapy against a placebo and chemotherapy regimen.
The study focuses on patients battling advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR mutations, following prior treatment with third-generation therapies.
In the primary analysis from April 2025, patients receiving the ivonescimab combination exhibited a median overall survival of 16.8 months, compared to 14.0 months for the placebo group.
While initially showing a positive trend without reaching statistical significance, subsequent evaluations highlighted improving outcomes.
By September 2025, extended monitoring of Western participants yielded a hazard ratio of 0.78.
The most recent data cut in June 2026, featuring a 23.2-month median follow-up for Western patients, showcased an even stronger hazard ratio of 0.76.
Safety Profile And Regulatory Next Steps
With longer observation periods, the magnitude of survival benefits for Western participants now aligns with the results seen in Asian patients, who had longer follow-up times during earlier assessments.
Furthermore, ivonescimab maintained a manageable safety profile with no new adverse signals detected.
Summit has provided these updated findings to the FDA to support its Biologics License Application. The regulatory agency has set a target action date of November 14, 2026, to decide on the drug’s approval.
SMMT Price Action: Summit Therapeutics shares were up 2.26% at $14.96 at the time of publication on Wednesday, according to Benzinga Pro data.
Photo by Piotr Swat via Shutterstock
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