On November 30, 2015 Incyte Corporation (Nasdaq:INCY) reported that more than 60 abstracts featuring data from its ongoing clinical development program for Jakafi (ruxolitinib) will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 57th Annual Meeting December 5-8, 2015 in Orlando, FL (Press release, Incyte, NOV 30, 2015, View Source;p=RssLanding&cat=news&id=2118588 [SID:1234508359]).
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"We are very pleased to have a substantial amount of ruxolitinib data selected for presentation at the upcoming ASH (Free ASH Whitepaper) Annual Meeting," stated Rich Levy, MD, Chief Drug Development Officer, Incyte. "Not only will long-term data for COMFORT-II, one of ruxolitinib’s pivotal registration studies be shared, but also new data exploring its potential in combination with other compounds for myeloproliferative neoplasms and other hematologic cancers. Continuing to identify and research combinatorial synergies with our medicines and others in development is a critical part of our continued commitment to discovering new treatment options for patients with cancer."
Key abstract presentations, inclusive of studies sponsored by Incyte and Novartis as well as independent investigator studies, include:
Myelofibrosis
Long-Term Efficacy and Safety in COMFORT-II, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy for the Treatment of Myelofibrosis: 5-Year Final Study Results (Abstract #59)
Saturday, December 5, 2015, 9:30-11:30 AM EST, Room W224
The Impact of Anemia on Overall Survival in Patients with Myelofibrosis Treated with Ruxolitinib: an Exploratory Analysis of the COMFORT Studies (Abstract #1604)
Saturday, December 5, 2015, 5:30-7:30 PM EST, Hall A
Safety and Efficacy of Ruxolitinib in an 1869-Patient Cohort of Jump: An Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients with Myelofibrosis (Abstract #2799)
Sunday, December 6, 2015, 6:00-8:00 PM EST, Hall A
Phase 1b/2 Study of the Efficacy and Safety of Sonidegib (LDE225) in Combination with Ruxolitinib (INC424) in Patients with Myelofibrosis (Abstract #825)
Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
An Open-Label, Multicenter, 2-Arm, Dose-Finding, Phase 1b Study of the Combination of Ruxolitinib and Buparlisib (BKM120) in Patients with Myelofibrosis: Results from HARMONY Study (Abstract #827)
Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
A Phase 1B/2 Study of Ruxolitinib plus Pomalidomide in Myelofibrosis: Data from the MPNSG-0212 Trial (NCT01644110) (Abstract #826)
Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
Efficacy, Safety, and Confirmation of the Recommended Phase 2 Starting Dose of the Combination of Ruxolitinib (RUX) and Panobinostat (PAN) in Patients (Pts) with Myelofibrosis (MF) (Abstract #4060)
Monday, December 7, 2015, 6:00-8:00 PM EST, Hall A
Polycythemia Vera
Continued Treatment with Ruxolitinib Provides Additional Hematocrit Control and Spleen Volume Responses in Patients with PV Treated in the RESPONSE Study (Abstract #2804)
Sunday, December 6, 2015, 6:00-8:00 PM EST, Hall A
The Effect of Ruxolitinib on White Blood Cell Counts in Patients with Polycythemia Vera: Results From the RESPONSE Trial (Abstract #4070)
Monday, December 7, 2015, 6:00-8:00 PM EST, Hall A
Myeloproliferative Neoplasms
Safety and Efficacy of Combination Therapy of Interferon-Alpha 2 + JAK1-2 Inhibitor in the Philadelphia-Negative Chronic Myeloproliferative Neoplasms. Preliminary Results from the Danish COMBI-Trial – An Open Label, Single Arm, Non-Randomized Multicenter Phase II Study (Abstract #824)
Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
Other Hematologic Cancers
5-Azacytidine (AZA) in combination with ruxolitinib (rux) as therapy for patients (pts) with myelodysplastic/myeloproliferative neoplasms (Abstract #823)
Monday, December 7, 2015, 4:30-6:00 PM EST, Room W315
Full session details and data presentations at ASH (Free ASH Whitepaper) 2015 can be found at: View Source
About Jakafi (ruxolitinib)
Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, as Jakafi (ruxolitinib), for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is also indicated for treatment of 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 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 during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
The most common side effects of Jakafi include: anemia, low platelet count, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider 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 tuberculosis (TB), or have been in close contact with someone who has TB, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.