CSPC PHARMA: The interim analysis of the pivotal Phase II/III clinical study of KN026 has reached the primary endpoint of progression-free survival (PFS)

According to the Zhitong Finance APP, CSPC PHARMA (01093) announced that its subsidiary Shanghai Jinmant Biotech Co., Ltd. has collaborated with Jiangsu CanSino Biologics Inc. to develop KN026 (recombinant humanized anti-HER2 bispecific antibody injection) for a pivotal phase II/III clinical study (KC-WISE) in HER2-positive locally advanced, recurrent, or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) patients who have failed at least one systemic treatment (must include trastuzumab combined with chemotherapy). The independent data monitoring committee (IDMC) evaluated that the primary endpoint of progression-free survival (PFS) was met with statistical significance and clinical relevance.

KN026 is a HER2 bispecific antibody that can bind to two non-overlapping epitopes of HER2 simultaneously, leading to HER2 signal blockade, and its therapeutic effect is superior to that of trastuzumab and pertuzumab combination therapy. Results from multiple clinical studies at different stages indicate that KN026 has good efficacy and safety. Currently, several registration clinical studies targeting indications such as breast cancer and gastric cancer (including gastroesophageal junction adenocarcinoma) are ongoing. KN026 combined with chemotherapy for HER2-positive gastric cancer (including gastroesophageal junction adenocarcinoma) that has failed first-line standard treatment was granted breakthrough therapy designation by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) of the People's Republic of China in November 2023.

The KC-WISE (KN026-001) study is a randomized, multi-center, phase II/III clinical study aimed at evaluating the efficacy and safety of KN026 combined with chemotherapy in HER2-positive locally advanced, recurrent, or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) patients who have failed first-line standard treatment. In the phase III clinical study stage, the enrolled population consists of HER2-positive gastric cancer (including gastroesophageal junction adenocarcinoma) patients who have previously failed at least one line of standard treatment, randomly assigned in a 1:1 ratio to receive KN026 combined with chemotherapy or placebo combined with chemotherapy. The primary endpoints of the study are PFS and overall survival (OS) assessed by an independent review committee (IRC). The main purpose of the planned interim analysis is to conduct an efficacy analysis of PFS assessed by the IRC. The interim analysis results show that KN026 combined with chemotherapy significantly improves patients' PFS compared to existing standard treatments, reduces the risk of disease progression/death, and shows a trend towards OS benefit. Detailed data from this study will be presented at an upcoming international academic conference