AKESO (09926): The interim analysis of the HARMONi-2 study comparing Atezolizumab with Palbociclib for first-line treatment of PD-L1 positive NSCLC has achieved the key secondary endpoint of overall survival with statistical significance and clinical benefit.

AKESO (09926) announced that its independently developed globally pioneering dual-specificity antibody, Ywosyi (PD-1/VEGF), was compared in a single-agent study to the monoclonal antibody, Pembrolizumab. This was part of a randomized, double-blind, controlled, multicenter Phase III clinical study (AK112303/HARMONi-2) for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS1%). The results of the pre-specified interim analysis of overall survival (OS) assessed by an independent data monitoring committee (IDMC) showed that the study achieved the key secondary endpoint of OS, yielding positive results with statistical significance and clinical benefit. Detailed data of these results will be published at future international academic conferences and in academic journals. A total of 398 participants were enrolled in this study, with the primary endpoint being progression-free survival (PFS) and the key secondary endpoint being OS. In May 2024, the study achieved the primary endpoint of PFS, obtaining positive results with statistical significance and substantial clinical benefit. The median PFS for the Ywosyi group and the control group was 11.14 months and 5.82 months, respectively, with a PFS HR=0.51 (P<0.0001). These OS results demonstrate the breakthrough clinical value of Ywosyi as a next-generation cornerstone drug in tumor immunotherapy, providing significant benefits to patients. In 2025, this indication was approved for commercialization in China. Ywosyi broke through the contraindication of VEGF drugs in squamous cell carcinoma patients, offering a superior "chemotherapy-free" solution and gaining wide trust from clinicians and patients in real-world clinical applications.