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|Incyte Drug Jakafi® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients with Myelofibrosis|
“Results of these studies represent the continuing evolution in our
understanding of the clinical benefits of Jakafi for patients with
intermediate or high-risk myelofibrosis and further support my
confidence that long-term treatment with Jakafi may modify this
progressive and life-threatening blood cancer,” stated Srdan Verstovsek,
M.D., Ph.D., Professor,
“Data from the Phase I/II study provide the first evidence that
long-term treatment with Jakafi may stabilize or improve bone marrow
fibrosis, a key marker of worsening disease in patients with
myelofibrosis. These findings, in addition to what was presented at
Long-Term Outcomes from a Phase III Study Comparing Ruxolitinib with Best Available Therapy for the Treatment of Myelofibrosis: A 3-Year Update of COMFORT-II
In a three-year follow-up analysis of the COMFORT-II study, an overall survival advantage was observed in patients treated with Jakafi compared to patients receiving best available therapy. A 52 percent reduction in risk of death was observed in the Jakafi arm compared with best available therapy (HR=0.48; 95% CI, 0.28-0.85; p=0.009)1, and the estimated probability of overall survival was significantly greater with Jakafi compared to best available therapy (81 percent compared to 61 percent, respectively) at 144 weeks. Additionally, 51.4 percent of patients treated with Jakafi achieved a ≥35 percent reduction from baseline in spleen size over the course of the study. Spleen response was maintained, with the median duration of this response not yet reached in the study.
Anemia and thrombocytopenia were the most common adverse events over the three-year follow-up; however, the rates of these events decreased over time. Among patients randomized to Jakafi and included in the extension phase, the general frequency of the most common non-hematologic adverse events (peripheral edema, diarrhea and asthenia) did not change over time.
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
The slides used during the presentation can be accessed at: EHA 2013 - Bone Marrow Fibrosis Presentation
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,
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
Important Safety Information
Jakafi 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.
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.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of Jakafi,
the results of further research and development, other market or
economic factors and technological advances, and other risks detailed
from time to time in
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