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Data from Incyte's Oncology Portfolio Accepted for Presentation at the 61st Annual ASH Meeting


Incyte (Nasdaq:INCY) announces that numerous abstracts, including data from its clinical development programs for ruxolitinib (Jakafi®), itacitinib and ponatinib (Iclusig®) will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting 2019 in Orlando, Florida from December 7-10, 2019.

"We look forward to ASH 2019 and the opportunity to present data for our approved and late stage compounds from our oncology portfolio," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These data strengthen the body of evidence supporting treatments that may deliver meaningful benefit for patients with rare cancers like polycythemia vera and myelofibrosis, leukemias and serious conditions such as graft-versus-host disease."

Select key abstract presentations include:

Oral Presentations

Risk of Hemorrhage in Patients with Polycythemia Vera Exposed to Aspirin in Combination with Anticoagulants: Results of a Prospective, Multicenter, Observational Cohort Study (REVEAL) (Abstract #168)

Poster Sessions

Ruxolitinib (Jakafi): Myeloproliferative Neoplasms

U.S. OPTUM Database Study in Polycythemia Vera Patients: Thromboembolic Events (TEs) with Hydroxyurea (HU) vs Ruxolitinib Switch Therapy and Machine-Learning Model to Predict Incidence of TEs and HU Failure (Abstract #1659)1

A Retrospective Real-World Study of the Current Treatment Pathways for Myelofibrosis in the UK (The REALISM UK Study) (Abstract #1671)1

Patient-Reported Outcomes (PRO) Data from Patients (Pts) with Essential Thrombocythemia (ET) Enrolled in the MOST Study (Abstract #1665)

Ruxolitinib (RUX) Induced Meaningful and Directional Changes in the Bone Marrow Microenvironment of Patients with Myelofibrosis Enrolled in the COMFORT-I Study (Abstract #2948)

Baseline Mutational Status of Patients with Myelofibrosis and Anemia in the REALISE Trial and Impact on Outcome (Abstract #2952)1

Ruxolitinib for Patients (Pts) with Polycythemia Vera: Responders vs Non-Responders as Defined in the RESPONSE Trial (Abstract #2947)1

Disease and Clinical Characteristics of Patients with Myelofibrosis Enrolled in the MOST Study (Abstract #4190)

Real-World Dosing Patterns of Ruxolitinib in Patients with Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea (Abstract #4192)

Adherence to Treatment in Myelofibrosis Patients: Preliminary Results from Italian ROMEI Observational Study (Abstract #4179)1

Impact of Disease Burden in Myelofibrosis Patients: A Sub Analysis from Italian ROMEI Observational Study (Abstract #4188)1

Ruxolitinib (Jakafi): Graft-Versus-Host Disease

Disease Progression, Hospital Readmissions, and Clinical Outcomes of Patients with Steroid-Refractory Acute Graft-Versus-Host Disease: A Multicenter Chart Review (Abstract #1994)

Population Pharmacokinetics of Ruxolitinib in Patients with aGVHD Who Had an Inadequate Response to Corticosteroids (Abstract #4534)

Stratification of Responders and Non-Responders in the REACH-1 Trial Based on Serum Proteomic Analysis (Abstract #4531)

Itacitinib

Prophylactic Itacitinib (INCB039110) for the Prevention of Cytokine Release Syndrome Induced by Chimeric Antigen Receptor T-Cells (CAR-T-cells) Therapy (Abstract #1934)

A Biomarker Signature to Predict Complete Response to Itacitinib and Corticosteroids in Acute Graft Versus Host Disease (Abstract #3279)

Ponatinib (Iclusig)

Multicenter, Prospective and Retrospective Observational Cohort Study of Ponatinib in Patients with CML in Italy: Interim Analysis of the OITI Trial (Abstract #1652)

Real-World Treatment Patterns, Health-Care Costs and Predictors for TKI Changes in CML: Results from a Population Representative German Claims Data Analysis (Abstract #1645)

Interim Analysis of a Prospective Multicentre Study Using Next Generation Sequencing for Kinase Domain Mutational Analysis in CML Patients on First or Subsequent TKI Therapy (Abstract #2935)

Sequence of Second Generation Tyrosine Kinase Inhibitors (TKIs) in the Treatment of Patients with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukaemia - Real World Experience in the UK (Abstract #3434)

Ultra-Accurate Assessment of Pretreatment ABL1 Kinase Domain (KD) Mutations in Patients (Pts) with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Using Duplex Sequencing (DS)2

Real-Life Outcomes of Ponatinib Treatment in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL): Data from a Nationwide Belgian Registry (Abstract #4161)

Major Adverse Cardiac, Arterial Occlusive, and Venous Occlusive Events Among Chronic Myeloid Leukemia Patients Prescribed Ponatinib vs Bosutinib (Abstract #4751)

Full session details and data presentation listings for ASH 2019 can be found at https://ash.confex.com/ash/2019/webprogram/start.html.

About Jakafi® (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea as well as adults 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. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

About Iclusig® (ponatinib)

Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc., since acquired by Takeda Pharmaceutical Company Limited, to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

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 in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; 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, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.

1 Novartis-sponsored abstract.
2 Takeda-sponsored abstract.


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