All phases, Summit Therapeutics stock rises on positive cancer trial data

Summit Therapeutics Inc. (NASDAQ: SMMT) rose 3% Wednesday following the release of updated overall survival results from its global Phase III HARMONi clinical trial evaluating ivonescimab plus chemotherapy.

The trial, which enrolled patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer previously treated with a third-generation EGFR tyrosine kinase inhibitor, showed Western patients achieved an overall survival hazard ratio of 0.76, consistent with Asian patients in the study.

In the most recent analysis with a data cut-off date in June 2026, the median follow-up time for Western patients reached 23.2 months, compared to 9.2 months at the time of the primary analysis in April 2025. The hazard ratio of 0.76 was observed in both the full intention-to-treat population and the subgroup of Western patients. The median follow-up time for Asian patients was 32.7 months.

The primary overall survival analysis performed in April 2025 showed ivonescimab in combination with chemotherapy demonstrated a positive trend with a hazard ratio of 0.79, though it did not achieve statistical significance with a p-value of 0.057. Median overall survival was 16.8 months for patients receiving ivonescimab plus chemotherapy versus 14.0 months for those receiving placebo plus chemotherapy.

Summit has made the updated analysis available to the FDA as part of its ongoing Biologics License Application review. The company’s BLA has a PDUFA goal action date of November 14, 2026. The study previously demonstrated a statistically significant benefit in progression-free survival, one of the trial’s two primary endpoints.