Phase III Studies of APG-2449 in NSCLC Cleared by China CDE

文章预览

Ascentage Pharma (6855.HK) today announced that APG-2449, a FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), has been cleared by the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) to enter two registrational Phase III studies that will separately evaluate APG-2449 in patients with non-small cell lung cancer (NSCLC) who are resistant to or intolerant of second-generation anaplastic lymphoma kinase (ALK) TKIs; and treatment-naïve patients with ALK-positive advanced or locally advanced NSCLC. These two pivotal studies will be multicenter, open-label, randomized, registrational Phase III studies: first one is to evaluate the efficacy and safety of APG-2449 versus platinum-based chemotherapies in patients with NSCLC who are resistant to or intolerant of second-generation ALK TKIs. The second registrational Phase III study is designed to evaluate the efficacy and safety of APG-2449 versus crizotinib as frontline therapies for treatment-naïve patie ………………………………