By Fineline Cube 
China-based Akeso, Inc. (HKG: 9926) announced strongly positive results from the regulatory Phase III AK112-306/HARMONi-6 study for its PD-1/VEGF bispecific antibody ivonescimab. The study demonstrated significant improvements in progression-free survival (PFS) when used in combination with chemotherapy for first-line advanced squamous non-small cell lung cancer (sq-NSCLC). The Independent Data Monitoring Committee (IDMC) confirmed that the trial met its primary endpoint at the first pre-specified interim analysis, with results that were both statistically significant and clinically meaningful.
Clinical Trial Results
Data from the HARMONi-6 study showed that ivonescimab combined with chemotherapy outperformed tislelizumab plus chemotherapy in terms of PFS in the intention-to-treat (ITT) population. The trial enrolled a total of 532 patients, with approximately 63% having centrally located squamous cell carcinoma. Ivonescimab maintained a favorable safety profile, with no new safety signals identified.-Fineline Info & Tech