Summit Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its new drug application for ivonescimab, a bispecific antibody developed in partnership with Chinese biotech Akeso. The FDA is expected to make a decision by November 14, 2026.
Ivonescimab is being considered as part of a combination chemotherapy regimen for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have EGFR mutations. This submission comes after Summit reported that ivonescimab improved progression-free survival by nearly 50% compared to Merck’s Keytruda in a Phase III NSCLC study conducted in September 2024.
Despite this, challenges remain for ivonescimab. In May 2025, the Phase III HARMONi study confirmed significant improvement in progression-free survival over placebo but did not meet its overall survival goal. The combination treatment reduced the risk of death from all causes by 21%, which narrowly missed statistical significance.
The FDA previously informed Summit that “a statistically significant overall survival benefit is necessary to support marketing authorization”—but Summit indicated during an investor call in October 2025 that it would proceed with filing regardless.
“We do think that the totality of our data from a combination of efficacy and safety is a strong package,” said Urte Gayko, Summit’s chief regulatory, quality and pharmacovigilance officer during the call.
Summit pointed to subgroup data presented in September 2025 showing stronger overall survival outcomes among Asian patients treated with ivonescimab—reporting a 24% decrease in risk of death—while North American and European patients saw a 16% benefit.
Analysts at Truist Securities commented on September 8: “The bottom line is that the regulatory path for Ivonescimab in EGFR-mutant lung cancer is uncertain and reliant on an act of leniency by the FDA.”
