AKESO (09926): AK112-303/HARMONi-2 (CTR20222137) data will be announced in 2024 WCLC.

AKESO (09926) announced that data from AK112-303/HARMONi-2 (CTR20222137) has been presented at the Presidential Symposium of the 2024 World Lung Cancer Conference (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The clinical results were presented in an oral report by Professor Zhou Caicun, the former Director of Oncology at Shanghai Pulmonary Hospital and current Director of Oncology at Tongji University affiliated Oriental Hospital, and the President-elect of IASLC. AK112-303/HARMONi-2 (CTR20222137) is a Phase III randomized, double-blind clinical trial conducted in China to evaluate the efficacy of sintilimab (Tyvyt, PD-1/VEGF) monotherapy compared to pembrolizumab monotherapy as first-line treatment for locally advanced or metastatic NSCLC with PD-L1 expression (PD-L1 TPS1%). The primary endpoint of the study is PFS evaluated by IRRC according to RECIST v1.1, with secondary endpoints including OS, ORR, DoR, and safety, with a total of 398 enrolled subjects. Based on the positive results of this study, the company's partner SUMMIT has announced plans to conduct the HARMONi-7 study to evaluate sintilimab monotherapy versus pembrolizumab monotherapy in a global multicenter Phase III clinical trial for first-line treatment of metastatic NSCLC with high PD-L1 expression (PD-L1 TPS >50%). Sintilimab has become the first and only drug globally to demonstrate significantly better efficacy than pembrolizumab monotherapy in a head-to-head Phase III clinical trial. In August 2024, the new indication application for sintilimab has been accepted by the National Medical Products Administration (NMPA) of the People's Republic of China for priority review. Sintilimab provides a superior treatment option for first-line PD-L1-positive advanced NSCLC patients, offering a "chemo-free" treatment choice and becoming a new standard of care. Sintilimab (Tyvyt) is a globally innovative PD-1/VEGF bispecific tumor immunotherapy drug developed by the company. Sintilimab was approved for marketing by the NMPA on May 24, 2024 for the treatment of locally advanced or metastatic non-squamous NSCLC with EGFR mutations progressing after EGFR TKI therapy. Currently, sintilimab has one approved indication in China, with 8 Phase III clinical trials ongoing, including 2 international multicenter Phase III trials conducted overseas and 6 Phase III trials with PD-(L)1 monoclonal antibodies as positive control drugs. Sintilimab is currently being studied in over 25 clinical trials covering 17 indications including gastrointestinal tumors, hepatocellular carcinoma, and colorectal cancer.