Incyte (Nasdaq:INCY) today announced that multiple abstracts
featuring data from its oncology portfolio will be presented at the
upcoming European Hematology Association 2022 (EHA2022) Congress
(June 9-17; virtual and in Vienna).
“We are committed to advancing science that can lead to
solutions for patients with serious unmet medical needs, including
those with cancer,” said Steven Stein, M.D., Chief Medical Officer,
Incyte. “For that reason, we look forward to convening with the
oncology community and presenting data from across our portfolio,
including both Incyte-led and partnered programs.”
Key abstracts accepted by EHA include:
Oral Presentation
Long-term Efficacy and Safety Results from an Ongoing
Open-Label Phase 2 Study of Parsaclisib for the Treatment of
Autoimmune Hemolytic Anemia (AIHA) (Abstract #S286. Session:
Transfusion and Autoimmune Hemolytic Anemia. Session Time: Friday,
June 10, 11:30 a.m. - 12:45 p.m.)
Poster Presentations
A Real-World Evaluation of the Association Between Elevated
Blood Counts and Thrombotic Events in Polycythemia Vera: An
Analysis of Data from the Reveal Study (Abstract #P1062.
Session: Myeloproliferative neoplasms – Clinical)
Does Early Intervention in Myelofibrosis Impact Outcomes? A
Pooled Analysis of the COMFORT 1 and 2 Studies (Abstract
#P1037. Session: Myeloproliferative neoplasms - Clinical)
Ruxolitinib Demonstrates a Greater Corticosteroid-Sparing
Effect than Best Available Therapy in Patients with
Corticosteroid-Refractory/Dependent Chronic Graft-Vs-Host
Disease1 (Abstract #P1389. Session: Stem cell transplantation -
Clinical)
Real-World Safety of Ruxolitinib in Patients with
Intermediate or High Risk of Primary Myelofibrosis,
Post-Polycythemia Vera Myelofibrosis or Post-Essential
Thrombocythemia Myelofibrosis in China1 (Abstract #P1047.
Session: Myeloproliferative neoplasms - Clinical)
Efficacy and Safety of Parsaclisib-Ruxolitinib Combination
Therapy in Myelofibrosis Patients with Low vs Higher Baseline
Platelet Count: A Subgroup Analysis of Data from a Phase 2
Study (Abstract #P1063. Session: Myeloproliferative neoplasms -
Clinical)
A Phase 1 Study Evaluating Safety and Efficacy of Parsaclisib
in Combination with Bendamustine + Obinutuzumab in Patients with
Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
(Abstract #P1104. Session: Indolent and mantle-cell non-Hodgkin
lymphoma - Clinical)
A Phase 1 Study of Parsaclisib in Combination with
Investigator Choice of Rituximab, Bendamustine + Rituximab, or
Ibrutinib in Patients with Previously Treated B-Cell Lymphoma
(CITADEL-112): Preliminary Safety Results (Abstract #P1102.
Session: Indolent and mantle-cell non-Hodgkin lymphoma -
Clinical)
inMIND: A Phase 3 Study of Tafasitamab Plus Lenalidomide and
Rituximab Versus Placebo Plus Lenalidomide and Rituximab for
Relapsed/Refractory Follicular Lymphoma (FL) or Marginal Zone
Lymphoma (MZL) (Abstract #P1103. Session: Indolent and
mantle-cell non-Hodgkin lymphoma - Clinical)
Real-Life Effectiveness and Safety Outcomes of Ponatinib
Treatment in Patients with Chronic Myeloid Leukemia (CML) and
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
(PH+ALL): 5-Year-Data from a Belgian Registry (Abstract #P699.
Session: Chronic myeloid leukemia - Clinical)
Dose Modification Dynamics of Ponatinib in Patients with
Chronic-Phase Chronic Myeloid Leukemia (CP-CML) from the PACE and
OPTIC Trials2 (Abstract #P707. Session: Chronic myeloid
leukemia - Clinical)
All (e)Poster presentations will be made available as of Friday,
June 10, 2022, at 3:00 a.m. EST and will be accessible for
on-demand viewing until Monday, August 15, 2022, on the Congress
platform. For full session details and data presentation listings,
please see the EHA2022 online program
(https://ehaweb.org/congress/eha2022-hybrid/eha2022-congress/).
About Ruxolitinib (Jakafi®) Ruxolitinib (Jakafi®) is a
first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for
treatment of polycythemia vera (PV) in adults who have had an
inadequate response to or are intolerant of hydroxyurea, in adults
with intermediate or high-risk myelofibrosis (MF), including
primary MF, post-polycythemia vera MF and post-essential
thrombocythemia MF, for treatment of steroid-refractory acute GVHD
in adult and pediatric patients 12 years and older and for the
treatment of chronic GVHD after failure of one or two lines of
systemic therapy in adult and pediatric patients 12 years and
older.
Jakafi is marketed by Incyte in the U.S. and by Novartis as
Jakavi® (ruxolitinib) outside the U.S. Jakafi is a registered
trademark of Incyte. Jakavi is a registered trademark of Novartis
AG in countries outside the U.S.
About Tafasitamab (Monjuvi® / Minjuvi®) Tafasitamab is a
humanized Fc-modified CD19 targeting immunotherapy. In 2010,
MorphoSys licensed exclusive worldwide rights to develop and
commercialize tafasitamab from Xencor, Inc. Tafasitamab
incorporates an XmAb® engineered Fc domain, which mediates B-cell
lysis through apoptosis and immune effector mechanism including
Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and
Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is approved by
the U.S. Food and Drug Administration in combination with
lenalidomide for the treatment of adult patients with relapsed or
refractory DLBCL not otherwise specified, including DLBCL arising
from low grade lymphoma, and who are not eligible for ASCT. This
indication is approved under accelerated approval based on overall
response rate. Full approval for this indication may be contingent
upon results in a confirmatory trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval,
in combination with lenalidomide, followed by Minjuvi monotherapy,
for the treatment of adult patients with relapsed or refractory
diffuse large B-cell lymphoma (DLBCL) who are not eligible for
autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG.
Tafasitamab is co-marketed by Incyte and MorphoSys under the brand
name Monjuvi® in the U.S. and marketed by Incyte under the brand
name Minjuvi® in the EU.
XmAb® is a registered trademark of Xencor, Inc.
About Ponatinib (Iclusig®) Tablets 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.
Click here to view the Iclusig EU Summary of Medicinal Product
Characteristics.
Incyte has an exclusive license from Takeda Pharmaceuticals
International AG to commercialize ponatinib in the European Union
and 29 other countries, including Switzerland, UK, Norway, Turkey,
Israel and Russia. Iclusig is marketed in the U.S. by Millennium
Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited.
About Parsaclisib Parsaclisib is a potent, highly
selective, next-generation investigational novel oral inhibitor of
phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under
evaluation as a monotherapy in non-Hodgkin lymphomas and autoimmune
hemolytic anemia, and in combination with ruxolitinib and
tafasitamab for myelofibrosis and non-Hodgkin lymphomas,
respectively.
In December 2018, Innovent and Incyte entered into a strategic
collaboration for three clinical-stage product candidates,
including parsaclisib. Under the terms of the agreement, Innovent
has received the rights to develop and commercialize parsaclisib
and two other assets in Mainland China, Hong Kong, Macau and
Taiwan.
About Incyte Incyte is a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@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
from the Company’s or partner company’s ongoing clinical
development pipeline, and whether or when any development compounds
or combinations will be approved or commercially available for use
in humans anywhere in the world outside of the already approved
indications in specific regions, its presentation plans for the
upcoming EHA meeting and its goal of improving the lives of
patients, 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; the effects of the COVID-19 pandemic and measures to
address the pandemic on the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by the U.S. FDA and other
regulatory authorities outside of the United States; the efficacy
or safety of the Company’s products; the acceptance of the
Company’s products in the marketplace; market competition; sales,
marketing, manufacturing and distribution requirements; and other
risks detailed from time to time in the Company’s reports filed
with the Securities and Exchange Commission, including its annual
report and its quarterly report on Form 10-Q for the quarter ended
March 31, 2022. 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/20220526005194/en/
Media Catalina Loveman
+1 302 498 6171 cloveman@incyte.com
Investors Christine Chiou
+1 302 274 4773 cchiou@incyte.com
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