FDA accepts Summit's first ivonescimab filing; decision due 14 Nov 2026, with survival flagged as the key question

Summit Therapeutics/Ivonescimab

The FDA accepted Summit's application for ivonescimab plus chemotherapy in EGFR-mutant non-squamous lung cancer after targeted-pill (TKI) therapy, setting a 14 November 2026 decision date. The filing rests on the global HARMONi trial, which met progression-free survival but missed statistical significance on overall survival. The FDA told Summit a significant survival benefit is needed in this setting and that progression-free survival alone may not be enough.

• HARMONi: progression-free survival HR 0.52 (6.8 vs 4.4 months).
• Overall survival HR 0.79 (95% CI 0.62–1.01; p=0.057), not significant; a July 2026 update showed HR 0.76.
• PDUFA goal date: 14 November 2026.
• Summit reported $419M cash plus $271M short-term investments at 30 Jun 2026 and a going-concern warning.