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SUMMIT THERAPEUTICS INC · Data as of 2026-10-27
Upcoming catalysts
ivonescimab — Interim data
H2 2026
The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis.
Source filingivonescimab — PDUFA
Nov 14
HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib).
Source filingivonescimab — Topline data
H1 2027
At present time, Summit expects to complete enrollment in the non-squamous cohort of HARMONi-3 in the second half of 2026 and expects to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the first half of 2027.
Source filingivonescimab — Initial data
mid-2027
Data from the study under this collaboration agreement is expected to be generated by mid-2027.
Source filingivonescimab — Conference presentation
Oct 23–Oct 27
Results from this trial will be presented at the European Society for Medical Oncology Congress 2026 in a Presidential Symposium alongside the HARMONi-GI1 trial, an Akeso-sponsored trial from China in which ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS vs. durvalumab plus chemotherapy in first-line advanced biliary tract cancer.
Source filingExplore the free biotech catalyst calendar