The results are consistent with previous COMFORT-II and COMFORT-I study analyses, which demonstrate that Jakafi provides significant clinical benefits over best available therapy and placebo for patients suffering from intermediate or high-risk myelofibrosis.The slides used during the presentation can be accessed at: EHA 2013 - 3-Year COMFORT-II Presentation Long-Term Intervention Effects on Bone Marrow Morphology in Myelofibrosis: Patients Treated With Ruxolitinib and Best Available Therapy Data were presented from an exploratory analysis that evaluated long-term data of patients with MF who were treated with Jakafi (n=68) in a Phase I/II trial. Biopsies were obtained at baseline and at 24 (n=68) and 48 (n=18) months, and bone marrow fibrosis grade was determined by three expert hematopathologists using the World Health Organization scoring system and blinded to patient data and outcome. Stabilization or improvement of bone marrow fibrosis was observed at both time points, and by month 48, bone marrow fibrosis was stabilized in 56 percent of ruxolitinib-treated patients and improved in 22 percent. The percentage of ruxolitinib-treated patients with bone marrow fibrosis grade worsening at 24 and 48 months was 37 percent and 25 percent, respectively. Separate samples were also collected from a multicenter observational database from three European Union countries (160 biopsies in a cohort of 139 patients) in patients treated with best available therapy at 24 months (n=97) and 48 months (n=63) 9. Additional research is needed to understand the clinical impact of these findings. The slides used during the presentation can be accessed at: EHA 2013 - Bone Marrow Fibrosis Presentation About Myelofibrosis Myelofibrosis (MF) is a life-threatening blood cancer that belongs to a group of diseases referred to as myeloproliferative neoplasms (or MPNs). MF has a poor prognosis and limited treatment options. 2,3 While the exact prevalence of MF is uncertain, and estimates vary widely, based on extensive market research, Incyte estimates MF affects about 16,000 to 18,500 people in the U.S. 4 The enlarged spleen and debilitating symptoms of MF are linked to dysregulated signaling in the Janus kinase (JAK) pathway. This dysregulation may be caused by various mechanisms and mutations, such as the JAK2 V617F mutation. 5,6 Although allogeneic stem cell transplantation may cure myelofibrosis, the procedure is associated with significant morbidity and transplant-related mortality and is available to less the 5 percent of patients who are young and fit enough to undergo the procedure. 7 About Jakafi Jakafi is a prescription medicine used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States.
Important Safety InformationJakafi can cause serious side effects including: Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever. Infection: You may be at risk for developing a serious infection while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters. The most common side effects of Jakafi include dizziness and headache. These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away. Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had liver or kidney problems, are on dialysis, or have any other medical condition. Do not drink grapefruit juice while taking Jakafi. Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding. Please see the Full Prescribing Information available at www.incyte.com , which includes a more complete discussion of the risks associated with Jakafi. About Incyte Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, please visit the Company's website at www.incyte.com. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to the potential efficacy and therapeutic and commercial value of Jakafi (ruxolitinib), including that treatment with Jakafi may stabilize or reverse bone marrow fibrosis in patients with myelofibrosis, that Jakafi may provide a survival advantage, and that long-term treatment with Jakafi may modify this progressive and life-threatening blood cancer, and statements with respect to future studies improving our understanding of the significance of these findings, contain predictions and estimates and are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
|1.||Vannucchi, A, et al. Long-Term Outcomes From A Phase 3 Study Comparing Ruxolitinib With Best Available Therapy (BAT) For The Treatment of Myelofibrosis (MF): A 3 Year Update of Comfort II. Abstract #S1111.18th Congress of European Hematology Association (EHA). Stockholm, Sweden.|
|2.||Kvasnicka, HM, et al. Long Term Intervention Effects on Bone Marrow Morphology in Myelofibrosis: Patients Treated With Ruxolitinib and Best Available Therapy. Abstract #S591.18th Congress of European Hematology Association (EHA). Stockholm, Sweden.|
|3.||Cervantes F, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113:2895-2901.|
|4.||Gangat N, et al. DIPSS Plus: a refined dynamic international prognostic scoring system for primary myelofibrosis that incorporates prognostic information from karyotype, platelet count, and transfusion status. J Clin Oncol. 2011;29(4):392-397.|
|5.||Data on File. Incyte Corporation.|
|6.||Levine RL, Pardanani A, Tefferi A, Gilliland DG. Role of JAK2 in the pathogenesis and therapy of myeloproliferative disorders. Nat Rev Cancer. 2007;7:673-683.|
|7.||Vannucchi AM, Guglielmelli P, Tefferi A. Advances in understanding and management of myeloproliferative neoplasms. CA Cancer J Clin. 2009;59:171-191.|
|8.||Patriarca F, Bacigalupo A, Sperotto A, et al. Allogeneic hematopoietic stem cell transplantation in myelofibrosis: the 20-year experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Haematologica. 2008;93(10):1514-1522.|