Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in combination with chemotherapy as a first-line treatment for advanced or metastatic pancreatic ductal adenocarcinoma (PDAC).
The multi-center, randomized, double-blinded, placebo-controlled Phase III study aimed to evaluate the efficacy and safety of KN046 in combination with albumin paclitaxel and gemcitabine for irresectable, locally advanced, or metastatic PDAC in patients who had not received prior systemic treatment. The study has recorded the predetermined number of death events, but the overall survival (OS) did not reach the predetermined statistical endpoint.
This follows a similar disappointment in May of the previous year, when a Phase III study for KN046 combined with chemotherapy as a first-line treatment for non-squamous non-small cell lung cancer (NSCLC) failed to demonstrate a significant improvement in OS. Despite this, a clinical study for KN046 in combination with axitinib for NSCLC is still ongoing.- Flcube.com
