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)
- Saturday, December 7, 2019, 12:00-1:30p.m., Orange County
Convention Center, Room W314, Level 3
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
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
A Retrospective Real-World Study of the Current Treatment
Pathways for Myelofibrosis in the UK (The REALISM UK Study)
(Abstract #1671)1
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
Patient-Reported Outcomes (PRO) Data from Patients (Pts) with
Essential Thrombocythemia (ET) Enrolled in the MOST Study (Abstract
#1665)
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
Ruxolitinib (RUX) Induced Meaningful and Directional Changes
in the Bone Marrow Microenvironment of Patients with Myelofibrosis
Enrolled in the COMFORT-I Study (Abstract #2948)
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Baseline Mutational Status of Patients with Myelofibrosis and
Anemia in the REALISE Trial and Impact on Outcome (Abstract
#2952)1
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Ruxolitinib for Patients (Pts) with Polycythemia Vera:
Responders vs Non-Responders as Defined in the RESPONSE Trial
(Abstract #2947)1
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Disease and Clinical Characteristics of Patients with
Myelofibrosis Enrolled in the MOST Study (Abstract #4190)
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Real-World Dosing Patterns of Ruxolitinib in Patients with
Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea
(Abstract #4192)
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Adherence to Treatment in Myelofibrosis Patients: Preliminary
Results from Italian ROMEI Observational Study (Abstract
#4179)1
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Impact of Disease Burden in Myelofibrosis Patients: A Sub
Analysis from Italian ROMEI Observational Study (Abstract
#4188)1
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
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)
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
Population Pharmacokinetics of Ruxolitinib in Patients with
aGVHD Who Had an Inadequate Response to Corticosteroids (Abstract
#4534)
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Stratification of Responders and Non-Responders in the
REACH-1 Trial Based on Serum Proteomic Analysis (Abstract
#4531)
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Itacitinib
Prophylactic Itacitinib (INCB039110) for the Prevention of
Cytokine Release Syndrome Induced by Chimeric Antigen Receptor
T-Cells (CAR-T-cells) Therapy (Abstract #1934)
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
A Biomarker Signature to Predict Complete Response to
Itacitinib and Corticosteroids in Acute Graft Versus Host Disease
(Abstract #3279)
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
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)
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
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)
- Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County
Convention Center, Hall B, Level 2
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)
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
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)
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
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
- Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 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)
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
Major Adverse Cardiac, Arterial Occlusive, and Venous
Occlusive Events Among Chronic Myeloid Leukemia Patients Prescribed
Ponatinib vs Bosutinib (Abstract #4751)
- Monday, December 9, 2019, 6:00-8:00 p.m., Orange County
Convention Center, Hall B, Level 2
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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version on businesswire.com: https://www.businesswire.com/news/home/20191125005113/en/
Incyte Contacts Media
Catalina Loveman, +1 302 498 6171 cloveman@incyte.com
Investors Michael Booth, DPhil, +1 302 498 5914
mbooth@incyte.com
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