Akeso / Summit Therapeutics Submit BLA to the FDA for Ivonescimab (PD-1/VEGF Bispecific Antibody)

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. The application is for ivonescimab in combination with chemotherapy as second-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR mutations.

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

In May 2025, the study met its primary PFS endpoint and demonstrated a positive trend in OS. Preliminary analysis showed that ivonescimab significantly prolonged PFS compared with the control group (P < 0.00001), reducing the risk of disease progression or death by 48% (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; prespecified protocol significance threshold: 0.0448).

At the WCLC 2025 congress, Summit presented updated HARMONi data showing further improvements in both PFS and OS. With a median follow-up of 13.7 months, data maturity in Western populations increased, and the OS hazard ratio improved to 0.78 (P = 0.0332). In the North American subgroup, the survival benefit was particularly notable, with median OS not reached in the ivonescimab group compared with 14.0 months in the control group (HR = 0.70).