Wire flash
HealthSummit Therapeutics: Extended follow-up shows stronger survival benefit for lead lung cancer drug
Editorial responsibility
- No named human review is recorded for this page.
- Source reporting is collected, normalized, translated or condensed automatically when needed.
- Automatically published source-backed update
Summit Therapeutics announced updated overall survival data from its Phase 3 HARMONi study evaluating ivonescimab, an investigational bispecific antibody, combined with chemotherapy for EGFR-mutated non-small cell lung cancer. The latest analysis, with a 23.2-month median follow-up for Western patients, showed a hazard ratio of 0.76, improving from 0.78 in September 2025. The primary analysis in April 2025 showed median overall survival of 16.8 months for the ivonescimab group versus 14.0 months for placebo, though it did not reach statistical significance. The safety profile remained manageable with no new adverse signals. Summit has submitted these findings to the FDA to support its Biologics License Application, with a target action date of November 14, 2026.
Source report
Author: Vandana Singh Read Time: 4 min
Summit Therapeutics Inc. on Wednesday released updated overall survival (OS) data from its Phase 3 HARMONi study, evaluating the investigational bispecific antibody ivonescimab for the treatment of specific forms of lung cancer.
The study assesses ivonescimab in combination with chemotherapy versus placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously been 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 with advanced or metastatic non-squamous 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.
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.
Photo by Piotr Swat via Shutterstock
Disclaimer: Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below.
Source
Yahoo FinanceWestern
Part of this Story
Summit Therapeutics Says Extended Follow-Up Reveals Stronger Survival Advantages with Lead Cancer Drug