Akeso’s Ivonescimab (PD-1/VEGF Bispecific Antibody) Submits BLA to the FDA

On January 12, 2026, Summit Therapeutics announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ivonescimab, a PD-1/VEGF bispecific antibody developed by Akeso. The application seeks approval of ivonescimab in combination with chemotherapy as a second-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR mutations.

According to information compiled by DengYueMed, the BLA submission is supported by positive results from the global Phase III HARMONi trial. HARMONi is a multicenter, randomized, double-blind, placebo-controlled study (n = 438) evaluating ivonescimab or placebo in combination with chemotherapy in patients with EGFR-mutant NSCLC whose disease progressed after prior treatment with third-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs). The co-primary endpoints of the study were progression-free survival (PFS) and overall survival (OS).

In May 2025, the HARMONi trial met its primary PFS endpoint and demonstrated a favorable trend in OS. Preliminary analyses showed that ivonescimab significantly prolonged PFS compared with the control arm (P < 0.00001), with a 48% reduction in the risk of disease progression or death (HR = 0.52). Median OS was 16.8 months in the ivonescimab group versus 14.0 months in the control group (HR = 0.79, P = 0.057), narrowly missing the prespecified statistical significance threshold of 0.0448 defined in the study protocol.

Updated data were presented at the WCLC 2025 congress, where Summit Therapeutics reported further maturation of both PFS and OS outcomes. With a median follow-up of 13.7 months, OS data in Western populations showed increased maturity, with the hazard ratio improving to 0.78 (P = 0.0332). Notably, patients in the North American subgroup derived pronounced survival benefit, with median OS not yet reached in the ivonescimab arm compared with 14.0 months in the control arm (HR = 0.70).

These findings position ivonescimab as one of the most advanced PD-1/VEGF bispecific antibodies in late-stage development for EGFR-mutant NSCLC, and the FDA’s review of this BLA will be closely followed by the global oncology community, as highlighted by DengYueMed.