Kangfang Biology: AK112-303/HARMONi-2(CTR20222137) data released in 2024 WCLC

According to the Zhitong Finance APP, AKESO (09926) announced that the data of AK112-303/HARMONi-2 (CTR20222137) has been presented at the Presidential Symposium of the 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The clinical results were presented in oral form by the lead researcher, Professor Zhou Caicun, former director of the Department of Oncology at Shanghai Pulmonary Hospital and current director of the Department of Oncology at Tongji University Affiliated East Hospital, and the incoming president of IASLC.

AK112-303/HARMONi-2 (CTR20222137) is a Phase III randomized, double-blind clinical trial conducted in China to evaluate the efficacy of Atezolizumab (Tecentriq, PD-1/VEGF) monotherapy compared to Pembrolizumab monotherapy as first-line treatment for locally advanced or metastatic NSCLC with PD-L1 expression (PD-L1TPS≥1%). 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 subjects enrolled.

Based on the positive results of this study, the company's partner SUMMIT has also announced plans to conduct the HARMONi-7 study to evaluate Atezolizumab 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-L1TPS>50%).

Atezolizumab has become the first and only drug in the world to demonstrate significantly better efficacy than Pembrolizumab monotherapy in a head-to-head Phase III clinical study. In August 2024, the new indication application for Atezolizumab has been accepted by the National Medical Products Administration (NMPA) of the People's Republic of China for priority review. Atezolizumab provides a better treatment option of "chemo-free" for first-line advanced NSCLC lung cancer patients with PD-L1 expression, becoming a new standard treatment regimen.

Atezolizumab is a globally pioneering PD-1/VEGF bispecific tumor immunotherapy drug independently developed by the company. Atezolizumab 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 that have progressed after EGFR TKI treatment. Currently, Atezolizumab has been approved for one indication in China, with 8 Phase III clinical trials ongoing, including 2 international multicenter Phase III trials conducted overseas and 6 Phase III clinical trials with PD-(L) 1 monoclonal antibodies as positive control drugs. Atezolizumab is currently involved in over 25 clinical trials covering 17 indications including gastrointestinal tumors, hepatocellular carcinoma, colorectal cancer, and others