China-based Akeso Biopharma announced its PD-1/VEGF bispecific antibody (BsAb) ivonescimab achieved statistically significant overall survival (OS) improvement in the Phase III HARMONi-A trial for EGFR-mutant non-small cell lung cancer (NSCLC) after tyrosine kinase inhibitor failure. The study met both primary progression-free survival (PFS) endpoint (7.06 vs 4.8 months, HR=0.46) and key secondary OS endpoint in Chinese patients. Detailed results will be presented at upcoming international conferences following the drug's May 2024 approval by China's National Medical Products Administration (NMPA) for this indication.

Global partner Summit Therapeutics reported consistent efficacy in the international HARMONi trial, showing 48% risk reduction in PFS (HR=0.52) and encouraging early OS trends (HR=0.79). The dual mechanism targeting both PD-1 and VEGF pathways represents a novel approach for overcoming EGFR TKI resistance, addressing a critical unmet need in approximately 50% of Asian NSCLC patients with EGFR mutations.

According to PharmCube's NextBiopharm® database, ivonescimab is the only approved therapy among 65 drugs targeting PD1/PDL and VEGF/VEGFR. Click here to request a free trial for NextBiopharm®.