On November 1, 2017 Incyte Corporation (Nasdaq:INCY) reported that more than 30 abstracts including data from its clinical development programs for Jakafi (ruxolitinib), JAK1, PI3Kδ, PIM and BRD will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2017 in Atlanta, Georgia from December 9-12, 2017 (Press release, Incyte, NOV 1, 2017, View Source [SID1234521410]).
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“Data accepted for presentation include long-term, 4-year follow-up from our RESPONSE trial, updated data from our PI3Kδ inhibitor program in relapsed or refractory B-cell malignancies as well as first-in-man data from our BRD and PIM kinase inhibitor programs.”
“We look forward to presenting new data from across our clinical development portfolio,” said Steven Stein, M.D., Chief Medical Officer at Incyte. “Data accepted for presentation include long-term, 4-year follow-up from our RESPONSE trial, updated data from our PI3Kδ inhibitor program in relapsed or refractory B-cell malignancies as well as first-in-man data from our BRD and PIM kinase inhibitor programs.”
Select key abstract presentations include:
Jakafi (ruxolitinib)
Promising Results of a Phase 1/2 Clinical Trial of Ruxolitinib in Patients with Chronic Myelomonocytic Leukemia (Abstract #162)
Saturday, December 9, 2017, 12:00-1:30 PM, Building B, Level 3, B312-B314, Oral Session 637, Myelodysplastic Syndromes—Clinical Studies: Predicting Drug Response Using Novel Genomic Algorithms
Examining The Treatment Patterns And Blood Counts Among Patients With Polycythemia Vera Treated With Hydroxyurea In The United States: An Analysis From The REVEAL Study (Abstract #1633)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Role Of Symptom Burden In Disability Leave Among Patients With Myeloproliferative Neoplasms (MPNs): Findings From The Living With MPN Patient Survey (Abstract #1637)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Ruxolitinib Or Dasatinib In Combination With Chemotherapy For Patients With Relapsed/Refractory Philadelphia (Ph)-Like Acute Lymphoblastic Leukemia: A Phase I-II Trial (Abstract #1322)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
The Combination Of Ruxolitinib (RUX) With Decitabine (DAC) In Patients (Pts) With Post-Myeloproliferative Neoplasm Acute Myeloid Leukemia (Post-MPN AML): Interim Report Of A Phase I/II Trial (Abstract #1379)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
A Phase Ib Study To Assess The Safety And Tolerability Of Oral Ruxolitinib In Combination With Azacitidine In Patients With Advanced Phase Myeloproliferative Neoplasms (MPN), Including Myelodysplastic Syndromes (MDS) Or Acute Myeloid Leukaemia (AML) Arising From MPN (The Bloodwise / TAP PHAZAR Study On Behalf Of The UK MPN CSG) (Abstract #1649)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Results From The 208-Week (4-year) Follow-Up Of RESPONSE Trial, A Phase 3 Study Comparing Ruxolitinib (Rux) With Best Available Therapy (BAT) For The Treatment Of Polycythemia Vera (PV) (Abstract #322)
Sunday, December 10, 2017, 8:15 AM, Building C, Level 2, C208-C210,
Oral Session 634, Myeloproliferative Syndromes: Clinical: Phase III and Long-Term Outcome Studies in MPNs
Patient-Reported Symptom Burden And Peripheral Blood Counts Among Patients With Polycythemia Vera: And Analysis From The REVEAL Study (Abstract #2924)
Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
Safety And Efficacy Of Ruxolitinib (Rux) In An Open-Label, Multicenter, Expanded Treatment Protocol In Patients (Pts) With Polycythemia Vera (PV) Who Are Hydroxyurea (HU) Resistant Or Intolerant And For Whom No Alternative Treatments Are Available (Abstract #2918)
Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
Primary Analysis Of JUMP, A Phase 3b, Expanded-Access Study Evaluating The Safety And Efficacy Of Ruxolitinib In Patients With Myelofibrosis (N=2233) (Abstract #4204)
Monday, December 11, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Characteristics Of 809 Patients With Essential Thrombocythemia In Real-World Clinical Practice: A Chart Review Study In The United States (Abstract #1636)
Monday, December 11, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Real-World Patterns Of First-Line Hydroxyurea Treatment Among Patients With Essential Thrombocythemia In US Community Oncology Practices (Abstract #4203)
Monday, December 11, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Ponatinib
First Report of the Gimema LAL1811 Phase II Prospective Study of the Combination of Steroids with Ponatinib As Frontline Therapy of Elderly or Unfit Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Abstract #99)
Saturday, December 9, 2017, 9:30-11:00 AM, Building C, Level 2, C211-C213,
Oral Session 612, Acute Lymphoblastic Leukemia: Clinical Studies: Advances in the Treatment of ALL
Efficacy And Safety Of Ponatinib In Chronic Phase-Chronic Myeloid Leukemia (CP-CML) According To The Extent Of Treatment With Prior Tyrosine Kinase Inhibitors (TKIs): Final (5-Year) Results Of The PACE Study (Abstract #1617)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2
Arterial Occlusive Events (AOEs) In The Phase 2 Ponatinib PACE Trial: 5-Year Update In Heavily Treated Patients (Pts) With Chronic-Phase Chronic Myeloid Leukemia (CP-CML) (Abstract #2896)
Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
Pipeline
Results From A Phase 1/2 Study Of INCB050465, A Highly Selective And Highly Potent PI3Kδ Inhibitor, In Patients With Relapsed Or Refractory B-Cell Malignancies (CITADEL-101) (Abstract #410)
Sunday, December 10, 2017, 12:15 PM, Building C, Level 1, Hall C1, Oral Session 623, Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Indolent Lymphomas, Novel Therapies and Diagnostics
Preliminary Results From An Ongoing Phase 1/2 Study Of INCB053914, A Pan-Proviral Integration Sites For Moloney Virus (PIM) Kinase Inhibitor, In Patients With Advanced Hematologic Malignancies (Abstract #2585)
Sunday, December 10, 2017, 6:00-8:00 PM, Building A, Level 1, Hall A2,
Poster Session II
A Phase 1/2 Study Of The Oral Novel JAK1 Inhibitor INCB052793 As Monotherapy And In Combination With Standard Therapies In Patients With Advanced Hematologic Malignancies (Abstract #640)
Monday, December 11, 2017, 10:30 AM-12:00 PM, Building B, Level 5, Murphy BR1-2,
Oral Session 613, Acute Myeloid Leukemia: Clinical Studies: Novel Therapies for AML and APL
Preliminary Results From An Ongoing Phase 1/2 Study Of INCB057643, A Bromodomain And Extraterminal (BET) Protein Inhibitor, In Patients (pts) With Advanced Malignancies (Abstract #4048)
Monday, December 11, 2017, 6:00–8:00 PM, Building A, Level 1, Hall A2,
Poster Session III
Preclinical
The Pan-PIM Inhibitor INCB053914 Displays Potent Synergy At Low Doses In Combination With Ruxolitinib In Pre-Clinical Models Of MPNs (Abstract #1661)
Saturday, December 9, 2017, 5:30-7:30 PM, Building A, Level 1, Hall A2,
Poster Session I
Targeting Cell Non-Autonomous MAPK Activation As A Novel Therapeutic Strategy In Myeloproliferative Neoplasms (Abstract #381)
Sunday, December 10, 2017, 10:00 AM, Building C, Level 2, C208-C210, Oral Session 635, Myeloproliferative Syndromes: Basic Science: Identification of novel targets for the treatment of myeloproliferative neoplasms
Redundant JAK, SRC And PI3 Kinase Signaling Pathways Regulate Cell Survival In Human Ph-Like ALL Cell Lines And Primary Cells (Abstract #717)
Monday, December 11, 2017, 2:45-4:15 PM, Building B, Level 2, B216-B217
Full session details and data presentation listings for ASH (Free ASH Whitepaper) 2017 can be found at: View Source
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.