Positive Results from HARMONi-6 Study
The HARMONi-6 trial demonstrated a significant progression-free survival benefit for ivonescimab plus chemotherapy with a hazard ratio of 0.60 and a p-value of less than 0.0001. Median progression-free survival was 11.14 months compared to 6.90 months for the control arm, showing a difference of 4.24 months.
Expansion of Phase III Clinical Development Programs
Summit Therapeutics announced the expansion of their Phase III clinical development programs with the initiation of the global Phase III HARMONi-GI3 trial, evaluating ivonescimab in first-line unresectable colorectal cancer, expanding beyond lung cancer.
Upcoming BLA Submission for Ivonescimab
Summit plans to submit a Biologics License Application (BLA) for ivonescimab in Q4 2025 based on the results of the HARMONi study, aiming for approval in the United States.