Incyte Corporation (Nasdaq: INCY) announced today that several analyses from clinical studies of Jakafi ® (ruxolitinib) were presented at the 2012 American Society of Hematology (ASH) Annual Meeting from Dec. 8 to 11 at the Georgia World Congress Center in Atlanta. Jakafi, an oral Janus kinase (JAK) inhibitor, is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF).
Of 24 Jakafi-related abstracts accepted for presentation at ASH, six are oral presentations. Two of the oral presentations highlight long-term results from both COMFORT-I and COMFORT-II in which patients with MF treated with Jakafi had improved survival over placebo and best available therapy, suggesting an overall survival benefit in patients with intermediate or high-risk MF. Additionally, data from this longer-term two-year follow-up show that improvements in quality of life measures and reductions in spleen volume were maintained with continued treatment.
Other data presented at ASH include results from a three-year follow-up of patients with polycythemia vera (PV) in a Phase II study, showing that ruxolitinib treatment resulted in durable response rates by modified European Leukemia Net criteria and improvements in PV-related symptoms.
“The long-term data for Jakafi continue to demonstrate tangible benefits for patients with myelofibrosis, including better management of this progressive and debilitating disease and an apparent improvement in overall survival,” stated Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. “In addition, the three-year results from the Phase II trial of ruxolitinib in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea are promising, and I look forward to seeing the Phase III data and the potential to use ruxolitinib to treat patients with PV.”“In addition to the promising overall survival data from the two COMFORT trials, exploratory analyses of the COMFORT-I trial provided additional guidance on dose titration. We’re confident this information will help physicians find the optimal dose for each patient and maintain long-term treatment with Jakafi, providing the potential for longer survival,” said Richard Levy, M.D., Incyte’s Chief Drug Development and Medical Officer.