Incyte (Nasdaq: INCY) today announced that several abstracts
featuring data from its oncology portfolio will be presented at the
upcoming 2024 American Society of Clinical Oncology (ASCO) Annual
Meeting held May 31 – June 4 in Chicago, and at the European
Hematology Association 2024 (EHA2024) Congress held on June 13-16
in Madrid, Spain, and virtually.
"The data being presented at ASCO and EHA demonstrates Incyte’s
dedication to our comprehensive research approach to identifying
new first and best in class treatments for cancer patients," stated
Steven Stein, M.D., Chief Medical Officer at Incyte. "The research
we're presenting emphasizes promise within our oncology pipeline in
areas where there is a continued need for therapeutic development
across a breadth of cancers."
Key abstracts accepted for presentation at ASCO and EHA
include:
ASCO Abstracts
Abstracts will be available to registered attendees on the ASCO
Congress platform beginning on May 23, 2024. Posters and slides
will be available to registered attendees at the scheduled session
start time.
Poster Presentations
INCB099280
A Phase 1 study of the Small-Molecule PD-L1 inhibitor
INCB099280 in Select Advanced Solid Tumors: Updated Safety,
Efficacy, and Pharmacokinetics (PK) Results (Abstract #2608.
Session: Developmental Therapeutics—Immunotherapy. Saturday, June
1, 9:00 a.m. -12:00 p.m. ET)
INCB057643
Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in
Patients with Relapsed or Refractory Myelofibrosis (MF) and Other
Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #6576.
Session: Hematologic Malignancies—Leukemia, Myelodysplastic
Syndromes, and Allotransplant. Monday, June 3, 9:00 a.m.-12:00 p.m.
ET)
EHA Abstracts
Abstracts are available on the EHA2024 Congress platform and
accessible for on-demand viewing until August 15, 2024.
Oral Presentations
Ruxolitinib
Analysis of Molecular Mechanisms and Predictive Biomarkers of
Disease Transformation in Polycythemia Vera (Abstract #S217.
Topic: Myeloproliferative Neoplasms – Biology & Translational
Research. Friday, June 14, 8:45 a.m. – 10:00 a.m. ET)
Poster Presentations
Ruxolitinib
A Real-World Evaluation of Risk Factors for Disease
Progression in Patients With Polycythemia Vera (PV) Enrolled in
REVEAL (Abstract #P1047. Topic: Myeloproliferative Neoplasms -
Clinical. Friday, June 14)
Ruxolitinib Treatment in Patients With Polycythemia Vera
Reduces JAK2 Allele Burden and Improves Hematocrit Control and
Symptom Burden (Abstract #P1049. Topic: Myeloproliferative
Neoplasms - Clinical. Friday, June 14)
The Impact of New or Worsening Anemia on Clinical Outcomes in
2233 Patients With Myelofibrosis Treated With Ruxolitinib: Results
From the Expanded-Access JUMP Study (Abstract #P1044. Topic:
Myeloproliferative Neoplasms - Clinical. Friday, June 14)
High Rate of Disease Progression in Patients With Low-Risk
Myelofibrosis (MF) Enrolled in the Prospective MOST Study
(Abstract #P1053. Topic: Myeloproliferative Neoplasms - Clinical.
Friday, June 14)
Progression to Myelofibrosis in Patients With Essential
Thrombocythemia: An Analysis From the Prospective MOST Study
(Abstract #P1030. Topic: Myeloproliferative Neoplasms - Clinical.
Friday, June 14)
Zilurgisertib
ALK2 and JAK2 Inhibition for Improved Treatment of Anemia in
Myelofibrosis Patients: Preclinical Profile of an ALK2 Inhibitor
Zilurgisertib in Combination With Ruxolitinib (Abstract #P1019.
Topic: Myeloproliferative Neoplasms - Biology & Transitional
Research. Friday, June 14)
The Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib
(INCB000928) as Monotherapy or With Ruxolitinib in Patients with
Anemia Due to Myelofibrosis: Phase 1/2 Study Results (Abstract
#P1060. Topic: Myeloproliferative Neoplasms – Clinical. Friday,
June 14)
INCB057643
Bromodomain and Extra-terminal (BET) Inhibitor INCB057643 in
Patients With Relapsed or Refractory Myelofibrosis (MF) and Other
Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #P1065.
Topic: Myeloproliferative Neoplasms – Clinical. Friday, June
14)
INCA033989
Efficacy of INCA033989 in Chronic and Advanced Forms of
CALRdel52 and CALRins5 MPN models (Abstract #P1002. Topic:
Myeloproliferative Neoplasms - Biology & Translational
Research. Friday, June 14)
INCB160058
Preclinical Evaluation of INCB160058 – A Novel and
Potentially Disease-Modifying Therapy for JAK2V617F Mutant
Myeloproliferative Neoplasms (Abstract #P1028. Topic:
Myeloproliferative Neoplasms - Biology & Translational
Research. Friday, June 14)
Axatilimab
Axatilimab for Chronic Graft-Versus-Host Disease: Responses
in Fibrosis-Dominant Organs in AGAVE-201 (Abstract #P1321.
Topic: Stem Cell Transplantation – Clinical. Friday, June 14)
Pemigatinib
A Phase 2 Study of Pemigatinib (FIGHT-203; INCB054828) in
Patients With Myeloid/Lymphoid Neoplasms With Fibroblast Growth
Factor Receptor 1 Gene Rearrangement (Abstract #P1042. Topic:
Myeloproliferative Neoplasms - Clinical. June 14)
Tafasitamab
CD19 Expression Persists in Diffuse Large B-Cell Lymphoma
Patient Biopsies After Treatment With Tafasitamab (Abstract
#P1234. Topic: Lymphoma Biology & Translational Research.
Friday, June 14
EARLYMIND, a Retrospective, Multicentric Study in Real World
Settings to Characterize the Efficacy of Tafasitamab-Lenalidomide
in Transplant Ineligible Patients With Relapsed/Refractory Large
B-cell Lymphoma (Abstract #P1214. Topic: Aggressive Non-Hodgkin
Lymphoma – Clinical. Friday, June 14)
For full session details and data presentation listings, please
see the ASCO (https://conferences.asco.org) and EHA2024
(https://ehaweb.org/congress) online programs.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a 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; intermediate or high-risk myelofibrosis (MF),
including primary MF, post-polycythemia vera MF and post-essential
thrombocythemia MF in adults; steroid-refractory acute GVHD in
adult and pediatric patients 12 years and older; and 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 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 Monjuvi® (tafasitamab-cxix) [or Minjuvi®
(tafasitamab)]
Monjuvi® (tafasitamab-cxix) [or Minjuvi® (tafasitamab)] is a
humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.
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). MorphoSys and
Incyte entered into: (a) in January 2020, a collaboration and
licensing agreement to develop and commercialize tafasitamab
globally; and (b) in February 2024, an agreement whereby Incyte
obtained exclusive rights to develop and commercialize tafasitamab
globally.
In the United States, Monjuvi® (tafasitamab-cxix) received
accelerated approval 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 autologous stem cell transplant (ASCT). In Europe,
Minjuvi® (tafasitamab) received conditional Marketing Authorization
from the European Medicines Agency 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).
XmAb® is a registered trademark of Xencor, Inc.
Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the
“triangle” design are registered trademarks of Incyte.
About Pemazyre® (pemigatinib)
Pemazyre® (pemigatinib) is a kinase inhibitor indicated
in the United States for the treatment of adults with previously
treated, unresectable locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or other rearrangement as detected by an
FDA-approved test*. This indication is approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
Pemazyre is also the first targeted treatment approved for use
in the United States for treatment of adults with relapsed or
refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1
rearrangement.
In Japan, Pemazyre is approved for the treatment of patients
with unresectable biliary tract cancer (BTC) with a fibroblast
growth factor receptor 2 (FGFR2) fusion gene, worsening after
cancer chemotherapy.
In Europe, Pemazyre is approved for the treatment of adults with
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or rearrangement that have
progressed after at least one prior line of systemic therapy.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms
1, 2 and 3 which, in preclinical studies, has demonstrated
selective pharmacologic activity against cancer cells with FGFR
alterations.
Pemazyre is marketed by Incyte in the United States, Europe and
Japan.
Pemazyre is a trademark of Incyte Corporation.
About Incyte
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia. For additional
information on Incyte, please visit Incyte.com or follow us on
social media: LinkedIn, X, Instagram, Facebook, YouTube.
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 Incyte’s clinical
development pipeline, the promise presented by that pipeline,
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 and Incyte’s goal of improving the lives of patients,
contain predictions, estimates, and other forward-looking
statements.
These forward-looking statements are based on our current
expectations and are 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 and the
ability to enroll subjects in accordance with planned schedules;
determinations made by the FDA and regulatory agencies outside of
the United States; the efficacy or safety of our products; the
acceptance of our products in the marketplace; market competition;
unexpected variations in the demand for our products and the
products of our collaboration partners; the effects of announced or
unexpected price regulation or limitations on reimbursement or
coverage for our products; sales, marketing, manufacturing, and
distribution requirements, including our ability to successfully
commercialize and build commercial infrastructure for newly
approved products and any additional new products that become
approved; and other risks detailed from time to time in our reports
filed with the U.S. Securities and Exchange Commission, including
our annual report on Form 10-K and our quarterly report on Form
10-Q for the quarter ended March 31, 2024. We disclaim any intent
or obligation to update these forward-looking statements.
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