( MENAFN - PR Newswire) HONG KONG, Oct. 31, 2024 /PRNewswire/ -- Akeso Biopharma (9926) is pleased to announce the successful enrollment of the first patient in the AK112-309 trial, a randomized, controlled, multicenter Phase III registration study for biliary track tumor. This trial is designed to compare the ivonescimab combined regimen, a PD-1/VEGF bispecific antibody internally developed by Akeso, with the durvalumab (PD-L1) combined regimen for the first-line treatment of advanced biliary tract cancers (BTC).
The primary endpoint of the AK112-309 study is overall survival (OS). This study represents the sixth registrational Phase III clinical trial featuring ivonescimab, with a PD-1/L1 monoclonal antibody as the comparator. It underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment.
Furthermore, it highlights Akeso's capability to maximize the number of cancer patients globally that can benefit from its product portfolio through a strategic approach to clinical development. Previously, the positive results from a Phase II clinical study of ivonescimab in combination with chemotherapy for the first-line treatment of BTC were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings demonstrated that the ivonescimab regimen exhibits significant antitumor activity and a good safety profile in BTC.
At the time of the analysis, the median follow-up time .