Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. jointly announced that the IND application was approved in China for the pivotal trial of the anti-HER2 bispecific antibody KN026 combined with Docetaxel (albumin-binding), in the first-line HER2 positive recurrent metastatic breast cancer.

The study is a randomized, controlled, open, multicenter Phase III study to evaluate the efficacy and safety of KN026 in combination with albumin-binding docetaxel versus trastuzumab in combination with pertuzumab and docetaxel in first-line treatment of HER2-positive metastatic breast cancer. The trial plans to enroll 880 patients with PFS assessed by IRC as primary endpoint.

Breast cancer is the most prevalent and deadly cancer among women worldwide. According to the World Health Organization's report, a new case of breast cancer is diagnosed every 1.8 seconds. In China, the incidence of breast cancer has been rising year by year, resulting in 0.42 million new cases and 0.12 million deaths in 2020. Although medical advancements have significantly improved the survival of patients with early breast cancer, HER2-positive breast cancer remains a highly aggressive and heterogeneous subtype that requires new therapeutic strategies to continuously improve patient outcomes.

KN026 is a HER2 bispecific antibody developed by Alphamab Oncology, it has good tolerance and safety, and has shown significant antitumor activity against HER2-positive breast cancer in a number of clinical studies. An efficacy and safety results of KN026, a HER2-targeted bispecific antibody combined with docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer was published at SABCS in 2022, with an objective response rate (ORR) of 76.4%, median duration of response (mDoR) of 24.0 months, and disease control rate (DCR) of 100%. We will further explore the efficacy and safety of KN026 in combination with docetaxel through this registered clinical trial, in the hope of bringing more effective treatment options to patients with HER2-positive breast cancer.