Summit to seek FDA approval for Akeso’s ivonescimab for EGFR-TKI resistant NSCLC in Q4 2025

On October 20, Summit Therapeutics ("Summit"), the overseas partner of Akeso's globally first-in-class PD-1/VEGF bispecific antibody ivonescimab, announced that it will submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 for the indication of ivonescimab combined with chemotherapy in the treatment of EGFR-mutated non-squamous non-small cell lung cancer (NSCLC) following progression on third-generation EGFR-TKI therapy.

The decision to submit this BLA is based on a comprehensive consideration of the safety and efficacy profiles of FDA-approved therapies for EGFR-TKI-resistant indications, coupled with the positive results from the international multi-center Phase III HARMONi study and the urgent unmet medical need.

Simultaneously, Summit announced the initiation of the international multi-center Phase III HARMONi-GI3 clinical trial evaluating ivonescimab as a first-line treatment for colorectal cancer. Akeso has previously commenced a Phase III clinical study of ivonescimab as a first-line treatment for colorectal cancer in China.

To date, ivonescimab has 14 Phase III clinical trials underway globally, including four international multi-center Phase III studies.