Shares of Alphamab-B (ASX: 09966) rose more than 6% following news of a successful Phase III clinical trial. At the time of writing, the stock was up 4.22% to HK$6.92, with a trading volume of HK$5.15 million.
Clinical Trial Success
The catalyst for the move was an announcement made on June 10th. The company, in collaboration with CSPC PHARMA (ASX: 01093) subsidiary Shanghai Jinmante Biotechnology Co., Ltd., reported that its Phase III study for a breast cancer treatment has met its primary endpoint.
Trial Details and Results
The trial, designated KN026-003, evaluated the combination therapy of Ennituo (KN026) plus docetaxel for injection (HB1801) as a first-line treatment for HER2-positive advanced breast cancer. An independent data monitoring committee assessed that the study successfully achieved its pre-defined primary endpoint of progression-free survival, with the results showing significant statistical and clinical importance.
Study Design and Outcome
KN026-003 is a randomized, controlled, open-label, multi-center Phase III study that planned to enroll approximately 880 patients. Patients were randomized to compare the efficacy and safety of the KN026 combination against a standard THP regimen. According to the committee's evaluation, the KN026 combination significantly extended patient PFS compared to the THP regimen, reducing the risk of disease progression or death and showing a trend toward overall survival benefit.
Future Data Presentation
The detailed data from this study are scheduled to be presented at an upcoming international academic conference.