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Phase III HARMONi Trial Data Revealed at WCLC 2025

Summit Therapeutics Inc. (SMMT) | September 7, 2025

By Hannah Lewis

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Summit Therapeutics Inc. presented data from the Phase III HARMONi trial featuring ivonescimab at WCLC 2025.

The trial evaluated ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients.

Results show a positive trend in OS with a hazard ratio of 0.79 but did not reach statistical significance.

Positive Trend in OS

Ivonescimab plus chemotherapy demonstrated a positive trend in Overall Survival (OS) with a hazard ratio of 0.79.

Longer-Term Follow-Up

The longer-term follow-up of Western patients showed improving global OS trends with a nominal p-value of 0.0332.

Consistent Benefit Across Subgroups

Consistent benefit was observed across pre-defined subgroups in the analysis with longer-term follow-up.

  • Analysis with longer-term follow-up of Western patients showed improved hazard ratios and nominal p-values.
  • North American patients in the study demonstrated a median OS HR of 0.70 in the ivonescimab arm.
  • The data presented at WCLC 2025 indicates potential clinical significance for ivonescimab in EGFR-mutated NSCLC patients.

The Phase III HARMONi trial data presented at WCLC 2025 provides valuable insights into the efficacy of ivonescimab in treating EGFR-mutated NSCLC patients. The results, although not statistically significant, show promising trends in overall survival.