The board of directors of the Akeso, Inc. announced that the registration phase III clinical trial, AK112-303 (HARMONi-2) of ivonescimab (AK112, PD-1/VEGF), the Company's in-house developed first-in-class bi-specific antibody, versus pembrolizamab as first-line monotherapy for locally advanced or metastatic NSCLC patients with positive PD- L1 expression (PD-L1 TPS1%) met primary endpoint of progression-free-survival (PFS) superiority at a prespecified interim analysis conducted by the independent data monitoring committee (IDMC). The PFS benefit was demonstrated across all clinical subgroups, including those with PD-L1 low expression (PD-L1 TPS 1-49%), PD-L1 high expression (PD-L1 TPS50%), as well as other high-risk patients. The results showed: Among intent-to-treat (ITT) population, ivonescimab monotherapy achieved statistically significant and clinically meaningful PFS benefit versus pembrolizumab, hazard ratio (HR) is significantly better than expected.

Ivonescimab is the globally first and only drug to show superior efficacy compared with pembrolizumab as monotherapy in a phase III head-to-head setting. Ivonescimab demonstrated significant PFS benefit across patients with PD-L1 TPS 1- 49% and PD-L1 TPS>50%. PFS improvement was observed broadly in patients across subgroups, including squamous and non-squamous histologies, or subgroups of patients with/without liver metastases, with/without brain metastases etc.

398 participants were enrolled in this trial, including approximate 57.8% of participants were with PD-L1 TPS 1-49% and 42.2% of participants with PD-L1 TPS50%, which is in-line with real world scenario. The safety profile was good and no additional safety signals were identified. The results of AK112-303 (HARMONi-2) will be presented at a global upcoming major medical conference.

In real world scenario, more than 50% of NSCLC patients are with PD-L1 TPS1%. The results of this trial strongly prove the superior and broad clinical value of ivonescimab in the first-line treatment of NSCLC.