The FDA is currently reviewing Summit’s PD-1/VEGF bispecific as part of a chemotherapy combo for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
The FDA will issue a verdict on Summit Therapeutics’ closely watched bispecific antibody ivonescimab by November 14, a decision that could usher in the next era in cancer care.
The FDA accepted the biotech’s new drug application (NDA) on Thursday, kicking off more than nine months of regulatory review. Summit, which licensed ivonescimab from Chinese biotech Akeso, is proposing the dual PD-1/VEGF inhibitor as part of a combo chemotherapy regimen for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who harbor EGFR mutations.
An approval for ivonescimab could portend a shift in the cancer treatment world, which is currently dominated by Merck’s blockbuster PD-1 inhibitor Keytruda. In September 2024, Summit declared a key triumph over Keytruda in a Phase III NSCLC study, with ivonescimab improving progression-free survival (PFS) by nearly 50% versus the blockbuster drug.
Last year, however, turned out to be rough for ivonescimab. In May 2025, the Phase III HARMONi study—which Summit is using to back its NDA—confirmed a significant PFS benefit with the bispecific over placebo, but fell short of an overall survival (OS) goal. Ivonescimab plus chemotherapy lowered the risk of death from all causes by 21%, narrowly missing statistical significance.
The FDA at the time told Summit that “a statistically significant overall survival benefit is necessary to support marketing authorization”—but the biotech nevertheless indicated its intent to file in an investor call in October 2025.
“We do think that the totality of our data from a combination of efficacy and safety is a strong package,” Urte Gayko, Summit’s chief regulatory, quality and pharmacovigilance officer, said during the call.
Summit’s confidence in ivonescimab appears to come from disaggregated data presented in September 2025 showing strong OS outcomes in Asian patients—treatment with the ivonescimab combo in this population resulted in a 24% decrease in the risk of death. Meanwhile, patients from North America and European countries saw a 16% OS benefit.
“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,” analysts at Truist Securities told investors in a Sept. 8 note.
