China-based Akeso Biopharma (HKG: 9926) has announced the initiation of a Phase III clinical study for its bispecific antibody (BsAb) ivonescimab (AK112), which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF) in non-small cell lung cancer (NSCLC).
Global Phase III HARMONi Study Design and Patient Dosing
The global, randomized, double-blind Phase III HARMONi study aims to assess the efficacy and safety of ivonescimab combined with chemotherapy in locally advanced or metastatic non-squamous NSCLC with epidermal growth factor receptor (EGFR) mutations that have progressed after third-generation EGFR tyrosine kinase inhibitor (TKI) treatment. The first patient dosing has taken place in the US, and the study is expected to enroll over 400 subjects across the US, Canada, Europe, and China, under the name AK112-301 in China. Another study, HARMONi-3, is anticipated to complete first dosing in the second half of this year, focusing on the efficacy and safety of the combination therapy in first-line metastatic squamous NSCLC.
Ivonescimab: A Dual-Targeting Therapy with Synergistic Potential
Akeso’s in-house discovery, ivonescimab, is the world’s first PD-1/VEGF BsAb to enter Phase III trials. It blocks the PD-1 and VEGF pathways simultaneously, with the aim of producing synergistic anti-tumor effects. Summit Therapeutics Inc., (NASDAQ: SMMT) entered into a licensing deal with Akeso in December 2022, securing development and commercialization rights to the drug in the US, Canada, Europe, and Japan. Ivonescimab, which holds breakthrough therapy designation status in China, is currently undergoing multiple Phase III trials.-Fineline Info & Tech
