HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study, a pivotal multi-center, randomized, open-label, regulatory Phase III trial. The study aims to evaluate the efficacy and safety of HMPL-306 in patients with recurrent/refractory (R/R) acute myeloid leukemia (AML) featuring isocitrate dehydrogenase (IDH) 1 or 2 mutations.
The primary endpoint of the study is overall survival (OS), with secondary endpoints including event-free survival (EFS) and the rate of complete response (CR). It is anticipated that approximately 320 patients will be enrolled in this regulatory study.
HMPL-306 is a dual inhibitor targeting isocitrate dehydrogenase (IDH) 1 and 2 mutations, which are prevalent genetic alterations in malignant tumors such as AML. Notably, HMPL-306 has the capability to cross the blood-brain barrier, offering a potential therapeutic advantage by inhibiting both IDH1 and IDH2 mutations and overcoming resistance to single-agent IDH inhibitors.- Flcube.com
