- Plenary Scientific Session to highlight
Incyte-discovered novel anti-mutant CALR-targeted monoclonal
antibody INCA033989
- Data from three of the Company’s LIMBER
studies evaluating ruxolitinib in combination with parsaclisib and
its ALK2 and BET inhibitors to be presented
- Incyte to host an in-person analyst and
investor event on Sunday, December 11, 2022, from 8:00-9:30 p.m. CT
to discuss key data presentations at ASH
Incyte (Nasdaq:INCY) will present data from its oncology
portfolio at the upcoming 64th American Society of Hematology
Annual Meeting (ASH 2022), held December 10-13, 2022, in New
Orleans and virtually. More than 50 abstracts featuring Incyte
compounds will be presented, highlighting its robust portfolio and
clinical development programs.
“The data to be presented at ASH illustrate the scientific depth
and progress made across several of our key programs, including
ruxolitinib (Jakafi®), parsaclisib, tafasitamab
(Monjuvi®/Minjuvi®), pemigatinib (Pemazyre®) as well as our LIMBER
studies, which are evaluating new targets and combination
strategies to expand treatment options for patients with
myeloproliferative neoplasms (MPNs) and graft-versus-host disease
(GVHD),” said Peter Langmuir, M.D., Group Vice President, Oncology
Targeted Therapeutics, Incyte. “Notably, the plenary scientific
session at ASH will feature INCA033989, an Incyte-developed, novel
anti-mutant CALR-targeted monoclonal antibody. Additionally, a
combination study evaluating ruxolitinib with parsaclisib will be
featured as an oral presentation, and two studies evaluating
ruxolitinib with INCB000928 and INCB057643, our ALK2 and BET
inhibitors, respectively, will also be presented. These
presentations highlight our advancing portfolio and comprehensive
approach to identifying potential new treatments for patients with
cancer.”
Select key abstract presentations from Incyte-developed and
partnered programs include:
Plenary Scientific
Session
INCA033989
Discovery of INCA033989, a Monoclonal Antibody that
Selectively Antagonizes Mutant Calreticulin Oncogenic Function in
Myeloproliferative Neoplasms (MPNs) (Abstract #6. Plenary
Scientific Session: Hematology Disease Topics & Pathways:
Research, Diseases, Therapies, Myeloid Malignancies. Sunday,
December 11, 3:00 p.m. EST)
Oral Presentations
LIMBER (MPN)
Efficacy and Safety of Add-on Parsaclisib to Ruxolitinib
Therapy in Myelofibrosis Patients With Suboptimal Response to
Ruxolitinib: Final Results From a Phase 2 Study (Abstract #236.
Session: 634. Myeloproliferative Syndromes: Clinical and
Epidemiological: Latest Data for Combination and Emerging Targeted
Therapies in Myelofibrosis. Saturday, December 10, 3:15 p.m.
EST)
Ruxolitinib (GVHD)
Ruxolitinib in Pediatric Patients with Treatment-Naïve or
Steroid-Refractory Acute Graft-Versus-Host Disease: Primary
Findings from the Phase 1/2 REACH 4 Study1 (Abstract #572.
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD,
Immune Reconstitution: Critical Advances in GVHD Management.
Sunday, December 11, 2022, 1:15 p.m. EST)
Ruxolitinib (MPN)
Siremadlin, a Human Double Minute-2 (HDM2) Inhibitor, Added
to Ruxolitinib After Suboptimal Response to Ruxolitinib Alone in
Patients with Myelofibrosis: Results from Part 1 of the Phase 1/2
ADORE Study1 (Abstract #239. Session: 634.
Myeloproliferative Syndromes: Clinical and Epidemiological: Latest
Data for Combination and Emerging Targeted Therapies in
Myelofibrosis. Saturday, December 10, 2022, 4:00 p.m. EST)
Tafasitamab
MRD-Negativity as a Potential Surrogate Endpoint After
Frontline DLBCL Therapy: Pooled Analysis & Implications for
Clinical Trial Design2 (Abstract #322. Session: 627. Aggressive
Lymphomas: Clinical and Epidemiological: Prognostication and Risk
Stratification of Aggressive B-cell NHL. Saturday, December 10,
5:45 p.m. EST)
Ponatinib
Three-Year Update From the OPTIC Trial: A Dose-Optimization
Study of 3 Starting Doses of Ponatinib3 (Abstract #620.
Session: 632. Chronic Myeloid Leukemia: Clinical and
Epidemiological: Longer Term Response, TFR, Pregnancy, and
Disparities. Sunday, December 11, 5:45 p.m. EST)
Itacitinib
Itacitinib and Corticosteroids as Initial Treatment for
Chronic Graft-Versus-Host Disease: Phase 1/2 results from
GRAVITAS-309 (Abstract #771. Session: 722. Allogeneic
Transplantation: Acute and Chronic GVHD, Immune Reconstitution:
Novel Therapies for Graft-versus-Host Disease. Monday, December 12,
12:00 p.m. EST)
Poster Presentations
All accepted posters in Poster I sessions are available for
in-person participants from 6:30 p.m. – 8:30 p.m. EST and for
registered virtual participants from 10:00 a.m. – 8:30 p.m. EST on
Saturday, December 10. All accepted posters in Poster II sessions
are available for in-person participants from 7:00-9:00 p.m. EST
and for registered virtual participants from 10:00 a.m. – 9:00 p.m.
EST on Sunday, December 11. All accepted posters in Poster III
sessions are available for in-person participants from 7:00–9:00
p.m. EST and for registered virtual participants from 10:00 a.m. –
9:00 p.m. EST on Monday, December 12.
LIMBER (MPN)
A Phase 1/2 study of INCB000928 as Monotherapy or Combined
with Ruxolitinib (RUX) in Patients (Pts) with Anemia Due to
Myelofibrosis (MF) (Abstract #1714. Session: 634.
Myeloproliferative Syndromes: Clinical and Epidemiological: Poster
I)
INCB057643 Monotherapy in Patients with Relapsed or
Refractory Myelofibrosis: A Phase 1 Study (Abstract #4358.
Session: 634. Myeloproliferative Syndromes: Clinical and
Epidemiological: Poster III)
Ruxolitinib (GVHD)
Early Versus Late Treatment with Ruxolitinib in Patients with
Steroid-Refractory Acute Graft-Versus-Host Disease: A Post Hoc
Analysis from the Randomized Phase 3 REACH2 Study (Abstract
#2079. Session: 722. Allogeneic Transplantation: Acute and Chronic
GVHD, Immune Reconstitution: Poster I)
Early Versus Late Treatment with Ruxolitinib in Patients with
Steroid-Refractory Chronic Graft-Versus-Host Disease: A Post Hoc
Analysis from the Randomized, Phase 3 REACH3 Study (Abstract
#4714. Session: 722. Allogeneic Transplantation: Acute and Chronic
GVHD, Immune Reconstitution: Poster III)
The Probability of Being in Response (PBR): A Novel Efficacy
Endpoint for Chronic Graft Versus Host Disease (GVHD) Applied to
the REACH3 study of Ruxolitinib Versus BAT1 (Abstract #4720.
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD,
Immune Reconstitution: Poster III)
Ruxolitinib (MPN)
Direct and Indirect Costs of Patients with Myeloproliferative
Neoplasm Diseases (Abstract #2308. Session: 906. Outcomes
Research—Myeloid Malignancies: Poster I)
Characteristics and Clinical Outcomes in Patients (Pts) With
Polycythemia Vera (PV) Receiving Ruxolitinib (RUX) after
Hydroxyurea (HU): A Longitudinal Analysis from REVEAL (Abstract
#3031. Session: 634. Myeloproliferative Syndromes: Clinical and
Epidemiological: Poster II)
Disease Progression and Leukemic Transformation in Patients
with Lower-Risk Myelofibrosis (MF): An Analysis From MOST
(Abstract #3039. Session: 634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Poster II)
Real-World Use of Ruxolitinib in Patients with Myelofibrosis
who had Anemia or Thrombocytopenia at US Community Practices
(Abstract #3630. Session: 906. Outcomes Research—Myeloid
Malignancies: Poster II)
Prediction of Resistance to Hydroxyurea Therapy in Patients
with Polycythemia Vera: A Machine Learning Study (PV-AIM)1
(Abstract #3036. Session: 634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Poster II)
Ruxolitinib (Ph-like ALL)
A Phase 2 Study of Ruxolitinib with Chemotherapy in Children
with Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
(AALL1521/INCB18424-269): Biologic Characteristics and Minimal
Residual Disease Response of Patients with non-CRLF2-Rearranged JAK
Pathway Alterations (Abstract #2725. Session: 614. Acute
Lymphoblastic Leukemias: Therapies, Excluding Transplantation and
Cellular Immunotherapies: Poster II)
Parsaclisib
Safety and Efficacy of Parsaclisib in Combination with
Rituximab, Bendamustine + Rituximab, or Ibrutinib in Patients with
Previously Treated B-Cell Lymphoma: Analysis of a Phase 1
Dose-Finding Study (CITADEL 112) (Abstract #4202. Session: 623.
Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas:
Clinical and Epidemiological: Poster III)
Tafasitamab
firstMIND: Final Analysis from a Phase 1b, Open-Label,
Randomized Study to Assess Safety of Tafasitamab or Tafasitamab +
Lenalidomide in Addition to R‑CHOP in Patients with Newly Diagnosed
Diffuse Large B-Cell Lymphoma2 (Abstract #1619. Session: 626.
Aggressive Lymphomas Prospective Therapeutic Trials: Poster I)
frontMIND: A Phase III, Multicenter, Randomized,
Double-Blind Study of Tafasitamab + Lenalidomide + R-CHOP versus
R-CHOP Alone for Newly Diagnosed High-Intermediate and High-Risk
Diffuse Large B-Cell Lymphoma2 (Abstract #2947. Session: 626.
Aggressive Lymphomas: Prospective Therapeutic Trials: Poster
II)
L-MIND: A Safety and Efficacy Analysis of Tafasitamab in
Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(R/R DLBCL) Receiving Treatment for at Least 2 Years2 (Abstract
#2937. Session: 626. Aggressive Lymphomas: Prospective Therapeutic
Trials: Poster II)
Blocking the CD47-SIRPa Axis Enhances Tafasitamab-Mediated
Phagocytosis2 (Abstract #4185. Session: 622. Lymphomas:
Translational–Non-Genetic: Poster III)
Ultrasensitive MRD Profiling Predicts Outcomes in DLBCL after
Frontline Therapy with Tafasitamab in Combination with Lenalidomide
and R-CHOP2 (Abstract #1519. Session: 621. Lymphomas:
Translational—Molecular and Genetic: Poster I)
Pemigatinib
FIGHT-203, an Ongoing Phase 2 Study of Pemigatinib in
Patients with Myeloid/Lymphoid Neoplasms (MLNs) with Fibroblast
Growth Factor Receptor 1 (FGFR1) Rearrangement (MLNFGFR1): A Focus
on Centrally Reviewed Clinical and Cytogenetic Responses in
Previously Treated Patients (Abstract #1732. Session: 634.
Myeloproliferative Syndromes: Clinical and Epidemiological: Poster
I)
Myeloid/Lymphoid Neoplasms (MLNs) with Fibroblast Growth
Receptor 1 (FGFR1) Rearrangement (MLN-FGFR1): A US Real-World
Retrospective Cohort Study (Abstract #3048. Session: 634.
Myeloproliferative Syndromes: Clinical and Epidemiological: Poster
II)
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
Sunday, December 11, 2022, from 8:00-9:30 p.m. CT (9:00–10:30 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 90 days.
Conference call details will be provided on our website.
About LIMBER
Incyte is a leader in the discovery and development of therapies
for patients with myeloproliferative neoplasms (MPNs) and
graft-versus-host disease (GVHD). The Leadership In MPNs and GVHD
BEyond Ruxolitinib (LIMBER) program is designed to evaluate
multiple monotherapy and combination strategies to improve and
expand treatments for patients with MPNs and GVHD. The program
currently has three key areas of focus: development of a new,
once-daily formulation of ruxolitinib; ruxolitinib-based
combinations with new targets such as PI3Kδ, BET and ALK2; and new
therapeutic options such as Mutant CALR.
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 older4.
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 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 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.
* Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE:
Incyte; 2020.
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 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).
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 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.
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 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 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; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte and its partners’ 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 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, 2022. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
1 Novartis-sponsored abstract 2 MorphoSys-sponsored abstract 3
Takeda-sponsored abstract 4 Jakafi (ruxolitinib) tablets:
Prescribing Information. U.S. Food and Drug Administration.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221103005878/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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