SMF Notes NVS Novartis AG investigational JAK inhibitor INC424 data met primary endpoint in Phase III trial of patients with myelofibrosis

Co announced today that a pivotal Phase III trial of the investigational Janus kinase (JAK) inhibitor INC424 (also known as INCB018424 and INCB18424) has met its primary endpoint of significantly reducing spleen volume in patients with myelofibrosis. The study, called COMFORT-1 (COntrolled MyeloFibrosis Study with Oral JAK Inhibitor Therapy), showed treatment with INC424 provided a statistically significant reduction in spleen size in patients with primary MF, post- polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). The study also met the secondary endpoint of symptomatic improvement as measured by the modified Myelofibrosis Symptom Assessment Form Diary. Further, the safety profile of INC424 was consistent with previous studies, which included reversible thrombocytopenia and anemia. Results from COMFORT-1 are planned to be submitted for presentation at an upcoming medical congress.