Incyte Highlights Jakafi® (ruxolitinib) and Capmatinib Abstracts to be
Presented at the 2016 ASCO and EHA Annual Meetings
Incyte Corporation (Nasdaq: INCY) announces that more than 20 abstracts featuring its clinical development candidates will be
presented at the 2016 American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings. These
conferences will take place from June 3–7, 2016 (ASCO) in Chicago, Illinois and June 9–12, 2016 (EHA) in Copenhagen, Denmark.
“The abstracts to be presented at ASCO and EHA 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 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 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 Annual Meeting can be found at: http://abstracts.asco.org/. Full session details and data presentations at the 21st Congress of
the EHA 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.
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 presentation of data regarding the Company’s development portfolio and the potential effectiveness of such portfolio
and its COMFORT-I study, 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 March 31, 2016. Incyte disclaims any intent or obligation to update these
forward-looking statements.
Incyte Corporation
Media
Catalina Loveman, +1 302 498 6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil, +1 302 498 5914
mbooth@incyte.com
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