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.
Highlights of Key Data Presented
- Verstovsek, S, et al. Long-term outcome of ruxolitinib treatment in patients with myelofibrosis: Durable reductions in spleen volume, improvements in quality of life, and overall survival advantage in COMFORT-I.
- Cervantes, F, et al. Long-term safety, efficacy, and survival findings from COMFORT-II, a Phase III study comparing ruxolitinib with best available therapy for the treatment of myelofibrosis.
- Verstovsek, S, et al. Long-term efficacy and safety results from a Phase II study of ruxolitinib in patients with polycythemia vera.
- Talpaz, M, et al. Efficacy, hematologic effects, and dose of ruxolitinib in myelofibrosis patients with low starting platelet counts (50–100 x 109/L): A comparison to patients with normal or high starting platelet counts. 2012 ASH Oral_Talpaz
- Harrison, C, et al. EXPAND: a Phase 1b, open-label, dose-finding study of ruxolitinib in patients with myelofibrosis and baseline platelet counts between 50 × 109/L and 99 × 109/L. 2012 ASH Oral_Harrison
- Vannucchi, A, et al. Reductions in JAK2 V617F allele burden with ruxolitinib treatment in COMFORT-II, a Phase III study comparing the safety and efficacy of ruxolitinib with best available therapy. 2012 ASH Oral_Vannucchi
- Mesa, R, et al. Clinical benefits of ruxolitinib therapy in myelofibrosis patients with varying degrees of splenomegaly and symptoms. 2012 ASH Poster #1727
- Mesa, R, et al. Improvement in weight and total cholesterol and their association with survival in ruxolitinib-treated patients with myelofibrosis from COMFORT-I. 2012 ASH Poster #1733
- McMullin, M, et al. The use of erythropoietic-stimulating agents with ruxolitinib in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. 2012 ASH Poster #2838
- Verstovsek, S, et al. Effect of ruxolitinib on the incidence of splenectomy in patients with myelofibrosis: A retrospective analysis of data from ruxolitinib clinical trials. 2012 ASH Poster #2847
- Ouagari, K, et al. Cost-effectiveness of ruxolitinib versus best-available therapy for medical treatment of myelofibrosis: Canadian societal perspective. 2012 ASH Poster #4255
- Barosi, G, et al. An individual patient supply program for ruxolitinib for the treatment of patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. 2012 ASH Poster #2844
Important Safety Information
- Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
- Patients with platelet counts <200 × 109/L at the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered
- Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered
- Neutropenia (ANC <0.5 × 109/L) was generally reversible and was managed by temporarily withholding Jakafi
- Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly
- A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy
- There are no adequate and well-controlled studies of Jakafi in pregnant women. Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus
- Women taking Jakafi should not breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother