WILMINGTON, Del.--(BUSINESS WIRE)--
Incyte Corporation (Nasdaq: INCY) announces that more than 20 abstracts including data from its ongoing clinical development program for Jakafi® (ruxolitinib) and its small molecule development programs targeting JAK1, LSD1 and PI3Kδ will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting 2016 in San Diego, California from December 3-6, 2016.
“We are pleased to have an array of data highlighting the potential of our portfolio accepted for presentation at this year’s ASH meeting, including the pooled overall survival analysis of five-year data from our COMFORT-I and COMFORT-II trials, which reinforces the long-term clinical profile of Jakafi; data from INCB39110, our selective JAK1 inhibitor, in acute graft-versus-host disease; and emerging data from our LSD1 and PI3Kδ inhibitor programs in other hematologic diseases,” said Steven Stein, M.D., Incyte’s Chief Medical Officer.
Key abstract presentations and publications, inclusive of studies sponsored by Incyte, Novartis and independent investigator studies, include:
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Myelofibrosis |
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Effects of Long-Term Ruxolitinib (RUX) on Bone Marrow (BM) Morphology in Patients (pts) with Myelofibrosis (MF) Enrolled in the COMFORT-I Study (Abstract #1949) |
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• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634 |
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Ruxolitinib (RUX) plus Pomalidomide in Myelofibrosis (MF): Updated Results from the MPNSG-0212 Trial (NCT01644110) (Abstract #1939) |
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• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634 |
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Clinical Outcomes with Ruxolitinib (RUX) in Patients (pts) with Myelofibrosis (MF) Stratified by Transfusion Status: A Pooled Analysis of the COMFORT-I and -II Trials (Abstract #3118) |
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• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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A Pooled Overall Survival Analysis of 5-Year Data from the COMFORT-I and COMFORT-II Trials of Ruxolitinib (RUX) for the Treatment of Myelofibrosis (MF) (Abstract #3110) |
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• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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Safety and Efficacy of Ruxolitinib (RUX) for the Final Enrollment of JUMP: An Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients (pts) with Myelofibrosis (MF) (N = 2233) (Abstract #3107) |
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• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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Ruxolitinib (RUX) in Combination with 5-Azacytidine (AZA) as Therapy for Patients (pts) with Myelofibrosis (MF) (Abstract #1127) |
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• Monday, December 5, 2016, 4:30-6:00 PM PST, Ballroom Salons 15-17, Oral Presentation: 634 |
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Exploring the potential of JAK1/2 inhibitor Ruxolitinib (RUX) with reduced intensity hematopoietic cell transplantation (HCT) for Myelofibrosis (MF): Stage I results of a prospective trial conducted through the Myeloproliferative Disorders – Research Consortium (MPD-RC) (Abstract #1126) |
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• Monday, December 5, 2016, 4:30-6:00 PM PST, Pacific Ballroom Salons 15-17, Oral Presentation: 634 |
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Polycythemia Vera |
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Examining the Clinical Features and Underlying Cardiovascular Risk Among Patients with Polycythemia Vera in the REVEAL Study (Abstract #1934) |
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• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634 |
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Essential Thrombocythemia |
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Correlation between Treatment Outcomes, Baseline Characteristics and Molecular Responses in the MAJIC Study which compared Ruxolitinib (RUX) to Best Available Therapy in Essential Thrombocythemia (ET) (Abstract #1929) |
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• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 634 |
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Myeloproliferative Neoplasms |
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Impact of Myeloproliferative Neoplasms on Patients’ Employment Status and Work Productivity in the United States: Results from the Living with MPN Patient Survey (Abstract #4265) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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The impact of Myeloproliferative Neoplasms (MPNs) on patients’ quality of life and productivity: Results from the international MPN LANDMARK survey (Abstract #4267) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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Other Hematologic Malignancies |
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A Phase I Study of Ruxolitinib (RUX) Plus Nilotinib in Chronic Phase CML Patients with Molecular Evidence of Disease (Abstract #1892) |
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• Saturday, December 3, 2016, 5:30-7:30 PM PST, Hall GH, Poster Session: 632 |
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A Phase 1 Trial of Janus Kinase (JAK) Inhibition with INCB039110 in Acute Graft-Versus-Host Disease (aGVHD) (Abstract #390) |
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• Sunday, December 4, 2016, 12:00-1:30 PM PST, Grand Hall C, Oral Presentation: 722 |
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LSD1 Inhibition Induces Fetal Hemoglobin Expression and Provides a Novel Therapeutic Approach to Sickle Cell Disease (Abstract #2472) |
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• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 113 |
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Effects of INCB052793, a Selective JAK1 Inhibitor, in Combination with Anti Myeloma Agents on Human Multiple Myeloma (MM) In Vitro and In Vivo (Abstract #3297) |
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• Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 652 |
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Safety and efficacy of combined Ruxolitinib (RUX) and Decitabine in patients with blast-phase MPN and post-MPN AML: Results of a Phase I study (Myeloproliferative Diseases Research Consortium 109 trial) (Abstract #1124) |
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• Monday, December 5, 2016, 4:30-6:00 PM PST, Pacific Ballroom Salons 15-17, Oral Presentation: 634 |
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An ongoing open-label phase 1/2 study of INCB050465, a selective PI3Kδ inhibitor, in patients with previously treated B-cell malignancies (Abstract #4195) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 626 |
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Ruxolitinib (RUX) in Combination with Azacytidine (AZA) in Patients (pts) with Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPNs) (Abstract #4246) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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Phase I Study of Ruxolitinib (RUX) for Patients (pts) with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Who Failed at Least One Line of Therapy (Abstract #4318) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 637 |
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Phase I/II study of Ruxolitinib (RUX) with decitabine (DAC) in patients with post-myelofibrosis neoplasm acute myeloid leukemia (post-MPN AML): Phase I results (Abstract #4262) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 634 |
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A LYSA phase II study of oral JAK1/2 inhibitor Ruxolitinib in advanced relapsed/refractory (R/R) Hodgkin lymphoma (HL) (Abstract #4160) |
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• Monday, December 5, 2016, 6:00-8:00 PM PST, Hall GH, Poster Session: 624 |
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Full sessions details and data presentation listing for ASH 2016 can be found at: http://www.hematology.org/Annual-Meeting/Abstracts/2853.aspx
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, 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 also indicated for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) 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 develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, 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.
Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet count, low red blood cell counts, 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 hepatitis B, 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, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company’s development pipeline and its presentation plans for the upcoming ASH annual meeting, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risks related to the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2016. Incyte disclaims any intent or obligation to update these forward-looking statements.
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