– Sixteen oral presentations, as well as a
plenary session and poster presentations, highlight new advances
across eight of the Company’s medicines
– Plenary Scientific Session will feature the
full data from AGAVE-201 evaluating axatilimab, an anti-CSFR-1R
monoclonal antibody, in patients with chronic graft-versus-host
disease (GVHD)
– Incyte to host an in-person analyst and
investor event on Monday, December 11, 2023 from 12:00-1:30 p.m. PT
to discuss key data presentations at ASH
Incyte (Nasdaq:INCY) today announced that more than 40 abstracts
highlighting data from eight of its hematology and oncology
products will be presented at the upcoming 65th American Society of
Hematology Annual Meeting 2023 (ASH 2023), held December 9-12,
2023, in San Diego and virtually.
“We have continued to make significant progress in advancing our
hematology and oncology pipeline with the goal to deliver better
medicines for a range of diseases that have limited treatment
options, including myeloproliferative neoplasms (MPNs) and chronic
graft-versus-host disease (GVHD),” said Pablo J. Cagnoni, M.D.,
President and Head of Research and Development, Incyte. “We are
excited to showcase the depth of our portfolio and clinical
progress at this year’s ASH congress. In particular, we look
forward to the presentation of the axatilimab AGAVE-201 trial
results in patients with chronic GVHD at the Plenary Scientific
Session, as well as the numerous oral and poster presentations
including new data for our mutant CALR, BET, ALK2 and CK0804
programs in MPNs. Additionally, we are proud that the first
presentation of data for INCB160058, our new potentially disease
modifying JAK2V617F therapy for patients with MPNs, will be at this
year’s meeting.”
Select key abstract presentations from Incyte-developed and
partnered programs include:
Plenary Scientific
Session
Axatilimab
Safety and Efficacy of Axatilimab at 3 Different Doses in
Patients with Chronic Graft-Versus-Host Disease (AGAVE-201)1
(Abstract #1. Plenary Scientific Session. Sunday, December 10, 5:00
p.m. – 7:00 p.m. ET)
Oral Presentations
Ruxolitinib (MPN)
A Real-World Evaluation of Risk Factors for Disease
Progression in Patients with Polycythemia Vera (PV) Enrolled in
REVEAL (Abstract #385. Session: 906. Outcomes Research –
Myeloid Malignancies: Risk Factors and Health Disparities.
Saturday, December 9, 7:00 p.m. ET)
Phase 1/2 Study of the Activin Receptor-Like Kinase-2
Inhibitor Zilurgisertib (INCB000928, LIMBER-104) as Monotherapy or
with Ruxolitinib in Patients with Anemia Due to Myelofibrosis
(Abstract #624. Session: 634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Charting The Future Of MPN Therapies.
Sunday, December 10, 8:45 p.m. ET)
Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643
(LIMBER-103) in Patients with Relapsed or Refractory Myelofibrosis
(R/R MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study
(Abstract #750. Session: 634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Treatment and Outcomes in MPNs.
Monday, December 11, 2:45 p.m. ET)
Ruxolitinib (GVHD)
Ruxolitinib in Patients with Chronic Graft-Versus-Host
Disease: Three-Year Final Analysis of Efficacy and Safety of the
Phase 3 REACH3 Study2 (Abstract #654. Session: 722. Allogeneic
Transplantation: Acute and Chronic GVHD, Immune Reconstitution:
Innovative Approaches to GVHD Prevention and Treatment. Sunday,
December 10, 8:45 p.m. ET)
Tafasitamab
Tafasitamab for the Treatment of Relapsed/Refractory (R/R)
Diffuse Large B-cell Lymphoma (DLBCL) in the U.S. Real-World
Setting (Abstract #265. Session: 905. Outcomes Research –
Lymphoid Malignancies: Outcomes Research in Lymphoma/CLL:
Biomarkers, Dosing Strategies, and Big-Data. Saturday, December 9,
5:00 p.m. ET)
Itacitinib
Itacitinib for the Prevention of Immune Effector Cell
Therapy-Associated Cytokine Release Syndrome: Results from the
Phase 2 INCB 39110-211 Placebo-Controlled, Randomized Cohort
(Abstract #356. Session: 705. Cellular Immunotherapies: Late Phase
and Commercially Available Therapies: Prediction and Management of
CAR-T Cell Related Toxicity. Saturday, December 9, 7:15 p.m.
ET)
INCB160058
Preclinical Evaluation of INCB160058 – A Novel and
Potentially Disease-Modifying Therapy for JAK2V617F Mutant
Myeloproliferative Neoplasms (Abstract #860. Session: 631.
Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic
and Translational: Lineage Tracing and Novel Target Discovery.
Monday, December 11, 6:00 p.m. ET)
Poster Presentations
Ruxolitinib (MPN)
Effect of New or Worsening Anemia on Clinical Outcomes in
2,233 Patients with Myelofibrosis (MF) Treated with Ruxolitinib in
the Expanded-Access JUMP Study (Abstract #5174. Session: 906.
Outcomes Research—Myeloid Malignancies: Poster III. Monday,
December 11, 9:00 p.m. – 11:00 p.m. ET)
Ruxolitinib Treatment in Polycythemia Vera Results in
Reduction in JAK2 Allele Burden in Addition to Improvement in
Hematocrit Control and Symptom Burden (Abstract #4553. Session:
634. Myeloproliferative Syndromes: Clinical and Epidemiological:
Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)
High Rate of Disease Progression in Patients with Low-Risk
Myelofibrosis (MF) Enrolled in the Prospective, Real-World, MOST
Study Abstract #3803. Session: 906. Outcomes Research—Myeloid
Malignancies: Poster II. Sunday, December 10, 9:00 p.m. – 11:00
p.m. ET)
Progression to Myelofibrosis in Patients with Essential
Thrombocythemia: A Real-World Analysis from the Prospective MOST
Study (Abstract #2433. Session: 906. Outcomes Research—Myeloid
Malignancies: Poster I. Saturday, December 9, 8:30 p.m. – 10:30
p.m. ET)
Clinical and Disease Characteristics of Patients With
Myelofibrosis and Essential Thrombocythemia that Harbor a
Calreticulin (CALR) Gene Mutation: Subanalysis of the MOST
Study (Abstract #3812. Session: 906. Outcomes Research—Myeloid
Malignancies: Poster II. Sunday, December 10, 9:00 p.m. – 11:00
p.m. ET)
Comparison of the Enzymatic and Cellular Profiles of Clinical
JAK2 Inhibitors for the Treatment of Myelofibrosis (Abstract
#4532. Session: 631. Myeloproliferative Syndromes and Chronic
Myeloid Leukemia: Basic and Translational: Poster III. Monday,
December 11, 9:00 p.m. – 11:00 p.m. ET)
ALK2 and JAK2 Inhibition for Improved Treatment of Anemia in
Myelofibrosis Patients: Preclinical Profile of an ALK2 Inhibitor
Zilurgisertib in Combination with Ruxolitinib (Abstract #1789.
Session: 631. Myeloproliferative Syndromes and Chronic Myeloid
Leukemia: Basic and Translational: Poster I. Saturday, December 9,
8:30 p.m. – 10:30 p.m. ET)
The Association between Blood Cell Counts and Thrombotic
Events in Japanese Patients with Polycythemia Vera: A Retrospective
Database Study2 (Abstract #3191. Session: 634.
Myeloproliferative Syndromes: Clinical and Epidemiological: Poster
II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)
Tafasitamab
Real-World Use of Tafasitamab (tafa) for Relapsed or
Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) Among Racial
and Ethnic Minorities in the United States (Abstract #2415.
Session: 905. Outcomes Research – Lymphoid Malignancies: Poster I.
Saturday, December 9, 8:30 – 10:30 p.m. ET)
Tafasitamab in Combination with a CD20xCD3 Bispecific T-cell
Engager Significantly Prolongs Survival in Preclinical Lymphoma
Models3 (Abstract #2813. Session: 605. Molecular Pharmacology
and Drug Resistance: Lymphoid Neoplasms: Poster II. Sunday,
December 10, 9:00 – 11:00 p.m. ET)
Pemigatinib
Deep and Durable Cytogenetic and Molecular Responses with
Pemigatinib in Myeloid/Lymphoid Neoplasms with Fibroblast Growth
Factor Receptor 1 Rearrangement: The FIGHT-203 Study (Abstract
#4551. Session: 634. Myeloproliferative Syndromes: Clinical and
Epidemiological: Poster III. Monday, December 11, 9:00 p.m. – 11:00
p.m. ET)
Ponatinib
Long-term Results From the OPTIC Trial: A Dose-Optimization
Study of 3 Starting Doses of Ponatinib4 (Abstract #3164.
Session: 632. Chronic Myeloid Leukemia: Clinical and
Epidemiological: Poster II. Sunday, December 10, 9:00 – 11:00 p.m.
ET)
Ponatinib Versus Imatinib in Patients with Newly Diagnosed
Ph+ ALL: Subgroup Analysis of the Phase 3 PhALLCON Study4
(Abstract #2871. 614. Acute Lymphoblastic Leukemias: Therapies,
Excluding Transplantation and Cellular Immunotherapies: Poster II.
Sunday, December 10, 9:00 – 11:00 p.m. ET)
Itacitinib
Janus Kinase (JAK) 1 Inhibition Results in Significant
Changes in Serum Proteins and Peripheral T-Cell Populations that
Correlated with Clinical Scores in Chronic Graft-Versus-Host
Disease (GVHD) Patients (an Analysis from GRAVITAS-309)
(Abstract #2197. Session: 722. Allogeneic Transplantation: Acute
and Chronic GVHD, Immune Reconstitution: Poster I. Saturday,
December 9, 8:30 – 10:30 p.m. ET)
Axatilimab
Axatilimab Ameliorates Inflammation and Fibrosis by Targeting
the Macrophages in a Preclinical Model of Chronic GVHD
(Abstract #2540. Session: 201. Granulocytes, Monocytes, and
Macrophages: Poster II. Sunday, December 10, 9:00 – 11:00 p.m.
ET)
CK0804
A Phase 1b, Open-Label Study of Add on Therapy with CK0804 in
Participants with Myelofibrosis and Suboptimal Response to
Ruxolitinib5 (Abstract #1813. Session: 634. Myeloproliferative
Syndromes: Clinical and Epidemiological: Poster I. Saturday,
December 9, 8:30 – 10:30 p.m. ET)
More information regarding the congress is available on the ASH
website: https://www.hematology.org/meetings/annual-meeting. This
in-person event will be broadcast virtually and access to the
meeting’s virtual platform is included with registration.
Conference Call and Webcast Incyte will host an
in-person analyst and investor event on Monday, December 11, 2023,
from 12:00-1:30 p.m. PT (3:00–4:30 p.m. ET) to discuss the key data
presentations at ASH. The event will be webcasted and can be
accessed via the Events and Presentations tab of the Investor
section of Incyte.com and it will be available for replay for 30
days.
Conference call details will be provided on our website.
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 graft-versus-host disease (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 older6.
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) 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 Monjuvi®/Minjuvi® (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 diffuse large B-cell lymphoma (DLBCL) not otherwise
specified, including DLBCL arising from low grade lymphoma, and who
are not eligible for autologous stem cell transplant (ASCT). This
indication is approved under accelerated approval based on overall
response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s). Please see the U.S. full Prescribing
Information for Monjuvi for important safety information.
In Europe, Minjuvi® (tafasitamab) received conditional marketing
authorization in combination with lenalidomide, followed by
Minjuvi® monotherapy, for the treatment of adult patients with
relapsed or refractory DLBCL who are not eligible for ASCT.
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials. Its safety and efficacy for these investigational uses have
not been established in pivotal trials.
Monjuvi® and Minjuvi® 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 Europe and Canada.
XmAb® is a registered trademark of Xencor, Inc.
About Pemazyre® (pemigatinib) Pemazyre 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 test7. 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 Axatilimab Axatilimab is an investigational
monoclonal antibody that targets colony stimulating factor-1
receptor, or CSF-1R, a cell surface protein thought to control the
survival and function of monocytes and macrophages. In pre-clinical
models, inhibition of signaling through the CSF-1 receptor has been
shown to reduce the number of disease-mediating macrophages along
with their monocyte precursors, which has been shown to play a key
role in the fibrotic disease process underlying diseases such as
chronic graft-versus-host disease (GVHD) and idiopathic pulmonary
fibrosis (IPF). Phase 1/2 data of axatilimab in chronic GVHD
demonstrating its broad activity and tolerability was last
presented at the 63rd American Society of Hematology Annual
Meeting. Axatilimab was granted Orphan Drug Designation by the U.S.
Food and Drug Administration for the treatment of patients with
chronic GVHD and IPF. In September 2021, Syndax and Incyte entered
into an exclusive worldwide co-development and co-commercialization
license agreement for axatilimab. Axatilimab is being developed
under an exclusive worldwide license from UCB entered into between
Syndax and UCB in 2016.
Enrollment in the Company's global pivotal Phase 2 AGAVE-201
Phase 2 study evaluating the efficacy, safety, and tolerability of
axatilimab in patients with recurrent or refractory active chronic
GVHD who have received at least two prior lines of systemic therapy
is complete, and topline data is expected mid-2023. Additionally, a
Phase 1 combination trial of ruxolitinib and axatilimab, led by
Incyte, is in preparation and expected to initiate by end of the
first quarter of 2023, and a Phase 2b trial of axatilimab in
patients with idiopathic pulmonary fibrosis led by Syndax is
expected to begin in the fourth quarter of 2022.
For more information about AGAVE-201, please visit
https://www.clinicaltrials.gov/study/NCT04710576.
About Itacitinib Itacitinib (INCB039110) is a novel
and selective JAK1 inhibitor currently in clinical studies for the
first-line treatment of patients with acute and chronic
graft-versus-host disease (GVHD).
Itacitinib was discovered at Incyte, and Incyte holds the global
development and commercialization rights for itacitinib with the
exception of China, where the rights to develop and commercialize
itacitinib have been licensed to Innovent Biologics, Inc.
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 Incyte’s clinical development 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 Incyte’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, EMA, and other regulatory
authorities; the efficacy or safety of Incyte and its partners’
products; the acceptance of Incyte and its partners’ products in
the marketplace; market competition; sales, marketing,
manufacturing and distribution requirements; and other risks
detailed from time to time in Incyte’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 September
30, 2023. Incyte disclaims any intent or obligation to update these
forward-looking statements.
_________________________ 1 Syndax-sponsored abstract 2
Novartis-sponsored abstract 3 MorphoSys-sponsored abstract 4
Takeda-sponsored abstract 5 Cellenkos-sponsored abstract 6 Jakafi
(ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug
Administration. 7 Pemazyre (pemigatinib): Prescribing Information.
U.S. Food and Drug Administration.
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