Summit Therapeutics Inc. noted on April 23, 2025, that its partner, Akeso, Inc., announced positive topline results from the Phase III HARMONi-6 clinical trial. This study evaluated ivonescimab in combination with platinum-based chemotherapy in first-line locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) patients.
The HARMONi-6 trial met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to tislelizumab plus chemotherapy. This PFS benefit was observed in patients regardless of their PD-L1 expression status.
Akeso reported no new safety signals in this Phase III study. This marks the first known Phase III trial in NSCLC to show a statistically significant improvement over a PD-(L)1 inhibitor combined with chemotherapy in a head-to-head setting, further validating ivonescimab's potential.
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