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

Canonical page: https://technooptimist.io/stories/fda-accepts-summit-s-first-ivonescimab-filing-decision-due-14-nov-2026-66e6270c
Date: Jan 2026
About: [Summit Therapeutics](https://technooptimist.io/companies/summit-therapeutics.md) · [Ivonescimab](https://technooptimist.io/biotech/ivonescimab.md)
Original source: https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000068/smmt-20260630.htm

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.

## Key facts

- 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.

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