Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with tumors positive for PD-L1 expression (PD-L1 TPS >1%).
The randomized, double-blinded study aimed to improve progression-free survival (PFS) as its primary endpoint and enrolled 398 subjects. Among these, 57.8% had low PD-L1 expression (TPS 1-49%), and 42.2% had high PD-L1 expression (TPS≥50%), reflecting proportions consistent with real-world patient expression levels. The study successfully reached its primary endpoint of PFS improvement, with efficacy observed across both PD-L1-expressing subgroups and all treatment sub-groups. The overall safety profile of the ivonescimab group was favorable, with no new safety signals identified.
Ivonescimab is a bispecific antibody (BsAb) that targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), simultaneously blocking the PD-1 and VEGF pathways to potentially produce synergistic anti-tumor effects. In December 2022, Akeso entered into a USD 5 billion deal with US firm Summit Therapeutics Inc. (NASDAQ: SMMT), granting Summit exclusive development and commercialization rights to the drug in the US, Canada, Europe, and Japan. Earlier this month, ivonescimab was approved in China as a treatment combined with chemotherapy for locally advanced or metastatic non-squamous NSCLC with EGFR mutations that progress after treatment with EGFR tyrosine kinase inhibitors (EGFR TKIs).- Flcube.com
