Biopharmaceutical oncology company Summit Therapeutics Inc (NASDAQ:SMMT) announced on Monday that it has submitted a Biologics License Application to the US Food and Drug Administration (FDA) seeking approval for ivonescimab in combination with chemotherapy for second-line or later treatment of patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer.

The application, submitted in the fourth quarter of 2025, is supported by results from the global Phase III HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy versus placebo plus chemotherapy.

Summit highlighted a significant unmet need in this setting, with more than 14,000 patients in the United States eligible for second-line or later treatment annually.

If the application is accepted under standard review timelines, Summit anticipates a regulatory decision by the fourth quarter of 2026.

Separately, Summit said that as of 31 December 2025 the company had approximately USD710m in preliminary unaudited cash, cash equivalents, and short-term investments. This amount is preliminary and is subject to completion of financial closing procedures.

Summit