Date: 2016-12-30
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Incyte (USA - DE)
Product: ruxolitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor. Jakafi®/Jakavi® (INC424, ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases that are involved in regulating blood and immunological functioning. Myelofibrosis is associated with the deregulation of JAK 1 and 2. The product was approved by the European Commission in August 2012 for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The FDA has granted ruxolitinib Breakthrough Therapy Designation for the treatment of acute GVHD, designed to expedite the development and review of drugs for serious or life-threatening conditions, as well as Orphan Drug Designation for the treatment of GVHD.
Novartis licensed INC424 (ruxolitinib) from Incyte Corporation for development and commercialization outside the United States. Both the European Commission and the FDA granted INC424 (ruxolitinib) orphan drug status for myelofibrosis. Jakavi® is marketed in the United States by Incyte Corporation under the name Jakafi® for the treatment of patients with intermediate or high-risk myelofibrosis.
Disease: graft-versus-host disease
Therapeutic area: Transplantation
Country: USA
Trial
details: The REACH clinical trial program for ruxolitinib in steroid-refractory acute GVHD includes the Incyte -sponsored REACH-1 study--a single-cohort, pivotal Phase 2 study evaluating ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD--and is also expected to include collaborative Novartis -sponsored randomized pivotal studies in steroid-refractory acute GVHD and steroid-refractory chronic GVHD. The Novartis -sponsored pivotal studies are expected to begin in early 2017.
The primary endpoint of the REACH-1 study is overall response rate at day 28. Key secondary endpoints include duration of response, overall response rate at day 14, 56, and 100, non-relapse mortality and safety. (NCT02953678)
Latest
news: * On December 30, 2016, Incyte announced that the first patient has been treated in the REACH-1 pivotal Phase 2 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD). The primary endpoint of the REACH-1 study is overall response rate at day 28. Key secondary endpoints include duration of response, overall response rate at day 14, 56, and 100, non-relapse mortality and safety.
