On May 19, 2016 Incyte Corporation (Nasdaq: INCY) reported that more than 20 abstracts featuring its clinical development candidates will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings (Press release, Incyte, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169771 [SID:1234512564]). These conferences will take place from June 3–7, 2016 (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois and June 9–12, 2016 (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark.
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"The abstracts to be presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) illustrate both the diversity and the potential of our rich portfolio," stated Steven Stein, M.D., Incyte’s Chief Medical Officer. "We are especially pleased to present long-term data from the COMFORT-I Phase 3 study, which further advances the understanding of Jakafi in the treatment of patients with myelofibrosis. These five-year data, along with additional new data from capmatinib, our potent and highly selective c-MET inhibitor licensed to Novartis, underscore Incyte’s commitment to researching and progressing innovative therapies that have the potential to transform the lives of patients living with cancer."
Select ASCO (Free ASCO Whitepaper) Abstracts
Myelofibrosis
Long-term Outcomes of Ruxolitinib Therapy in Patients with Myelofibrosis: 5-Year Update from COMFORT-I (Abstract #7012)
June 6, 2016, 8:00–11:30 a.m., E354b Hall A
ReTHINK: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Ruxolitinib in Early Myelofibrosis patients with High Molecular Risk Mutations (Abstract #TPS7080)
June 6, 2016, 8:00–11:30 a.m., Hall A, Poster Board #67b
Solid Tumors
GEOMETRY duo-1: A Phase Ib/II, Multicenter Trial of Oral cMET inhibitor Capmatinib (INC280) ± Erlotinib vs. Platinum/Pemetrexed in Adult Patients with Epidermal Growth Factor Receptor (EGFR)-mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) with Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (TKI) Therapy (Abstract #TPS9109)
June 4, 8:00–11:30 a.m., Hall A, Poster Board #427a
Phase I Study of the Safety and Efficacy of the c-MET Inhibitor Capmatinib (INC280) in Patients with Advanced c-MET+ NSCLC (Abstract #9067)
June 4, 8:00–11:30 a.m., Hall A, Poster Board #390
Phase II Study of the Efficacy and Safety of the c-MET Inhibitor Capmatinib (INC280) in Patients with Advanced Hepatocellular Carcinoma (Abstract #4074)
June 4, 8:00–11:30 a.m., Hall A, Poster Board #66
Phase II Safety and Efficacy Results of a Single-arm Phase Ib/II Study of Capmatinib (INC280) + Gefitinib in Patients with EGFR-mutated, c-MET-positive Non-small Cell Lung Cancer (NSCLC) (Abstract #9020)
June 4, 3:00–4:15 p.m., E354b Hall A
Select EHA (Free EHA Whitepaper) Abstracts
Myelofibrosis
Long-Term Outcomes of Ruxolitinib Therapy in Patients with Myelofibrosis: 5-Year Final Efficacy and Safety Analysis from COMFORT-I (Abstract #S452)
June 11, 11:30–11:45 a.m., Hall A3
Safety and Efficacy of Ruxolitinib in Patients with Dipss Intermediate-1–Risk Myelofibrosis from JUMP: An Open-Label, Multicenter, Single-Arm Expanded-Access Study (Abstract # P296)
June 10, 5:15–6:45 p.m., Hall H
Polycythemia Vera
Ruxolitinib Reduces JAK2V617F Allele Burden in Patients with Polycythemia Vera enrolled in the RESPONSE Study (Abstract #S454)
June 11, 12:00–12:15 p.m., Hall A3
Ruxolitinib Proves Superior to Best Available Therapy in Patients with Polycythemia Vera Resistant to or Intolerant of Hydroxyurea and a Nonpalpable Spleen; Results from RESPONSE-2 (Abstract #S112)
June 10, 12:00–12:15 p.m., Auditorium 1
Essential Thrombocythaemia
Ruxolitinib Compared with Best Available Therapy for Essential Thrombocythaemia Patients Resistant or Intolerant to Hydroxycarbamide in MAJIC – An Investigator Lead Randomized Trial (Abstract #LB304)
June 10, 5:15–6:45 p.m., Hall H
Full session details and data presentations at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source Full session details and data presentations at the 21st Congress of the EHA (Free EHA Whitepaper) can be found at: http://www.ehaweb.org/congress-and-events/21st-congress/program/program-by-day/.
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 (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.