- Twenty presentations, including
late-breaking, oral and poster presentations, highlight advances
across seven of the company’s medicines
- Late-breaking data presentation at ASH will
feature results from the Phase 3 inMIND study evaluating
tafasitamab in follicular lymphoma (FL); data to be highlighted
during ASH press program
- Incyte to host virtual analyst and investor
event on Thursday, December 12, 2024, from 4:00-5:00 p.m. ET to
discuss key data presentations from ASH
Incyte (Nasdaq: INCY) today announced that the Company will
present new data from across its oncology portfolio at the 2024
American Society of Hematology (ASH) Annual Meeting in San
Diego.
“These data illustrate our innovative approach that aims to
identify new and best-in-class treatments for patients with a range
of cancers,” said Pablo J. Cagnoni, M.D., President and Head of
Research and Development, Incyte. “At ASH, we’re presenting
comprehensive data from our Phase 3 inMIND trial in relapsed or
refractory follicular lymphoma. This late-breaking presentation
provides valuable insights into the potential role of tafasitamab
in improving outcomes for FL patients who currently face limited
effective treatment options.”
Details on key abstracts accepted for presentation include:
ASH Abstracts
Late-Breaking Oral Presentation
Tafasitamab Tafasitamab Plus Lenalidomide and
Rituximab for Relapsed or Refractory Follicular Lymphoma: Results
from a Phase 3 Study (inMIND) Session: Late-Breaking Abstracts
Session. Publication Number: LBA-1. December 10, 10:30 a.m. ET
(7:30 a.m. PT).
Oral Presentations
Axatilimab Dynamics of Overall and Organ-Specific
Responses to Axatilimab in Chronic Graft-Versus-Host Disease:
Analysis from the AGAVE-201 Study Session: 722. Allogeneic
Transplantation: Acute and Chronic GVHD and Immune Reconstitution:
Predicting and Treating Acute and Chronic GVHD. Publication Number:
98. December 7, 12:45 p.m. ET (9:45 a.m. PT).
INCB057643 Safety and Efficacy of Bromodomain and
Extra-Terminal Inhibitor INCB057643 in Patients with Relapsed or
Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A
Phase 1 Study Session: 634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Advancing Treatment Paradigms in
Myeloproliferative Neoplasms and Mastocytosis. Publication Number:
658. December 8, 8:15 p.m. ET (5:15 p.m. PT).
Poster Presentations
Ruxolitinib (Myeloproliferative Neoplasms [MPN])
Clinical and Molecular Characterization of Disease Progression
in Patients (Pts) with Low-Risk Myelofibrosis (MF) Enrolled in the
MOST Study Poster Session: 631. Myeloproliferative Syndromes
and Chronic Myeloid Leukemia: Basic and Translational: Poster II.
Publication Number: 3136. December 8, 9:00 p.m. – 11:00 p.m. ET.
(6:00 p.m. – 8:00 p.m. PT).
Molecular Predictors of Disease Progression to Myelofibrosis
(MF) in Patients (Pts) with Polycythemia Vera (PV) Enrolled in
REVEAL Poster Session: 631. Myeloproliferative Syndromes and
Chronic Myeloid Leukemia: Basic and Translational: Poster II.
Publication Number: 3145. December 8, 9:00 p.m. – 11:00 p.m. ET.
(6:00 p.m. – 8:00 p.m. PT).
Real-World Treatment Patterns and Blood Count Control in
Patients with Polycythemia Vera Who Switched From Hydroxyurea to
Ruxolitinib Poster Session: 908. Outcomes Research: Myeloid
Malignancies: Poster II. Publication Number: 3813. December 8, 9:00
p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT).
Clinical Outcomes in Patients with Myelofibrosis Treated with
Ruxolitinib and Anemia-Supporting Medications Poster Session:
634. Myeloproliferative Syndromes: Clinical and Epidemiological:
Poster III. Publication Number: 4546. December 9, 9:00 p.m. – 11:00
p.m. ET. (6:00 p.m. – 8:00 p.m. PT).
Ruxolitinib (Graft-versus-host Disease [GVHD])
Real-World Ruxolitinib and Corticosteroid Treatment Patterns in
Patients with Chronic Graft-Versus-Host Disease in the United
States Poster Session: 722. Allogeneic Transplantation: Acute
and Chronic GVHD and Immune Reconstitution: Poster III. Publication
Number: 4900. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. –
8:00 p.m. PT).
Tafasitamab Real-World Effectiveness of Tafasitamab
(Tafa) for the Treatment of Relapsed/Refractory Diffuse Large
B-Cell Lymphoma (R/R DLBCL) in the United States Poster
Session: 906. Outcomes Research: Lymphoid Malignancies Excluding
Plasma Cell Disorders: Poster I. Publication Number: 2375. December
7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT).
Maintenance of CD19 Expression After Tafasitamab Treatment in
Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(R/R DLBCL) From Clinical Trial and Real-World Settings Poster
Session: 622. Lymphomas: Translational – Non-Genetic: Poster II.
Publication Number: 2991. December 8, 9:00 p.m. – 11:00 p.m. ET.
(6:00 p.m. – 8:00 p.m. PT).
Axatilimab Axatilimab Abrogates Inflammatory Cytokines
and Chemokines and Interrupts the Differentiation of Monocytes to
Macrophages, a Pathogenic Driver of Inflammation and Fibrosis in
cGVHD Poster Session: 201. Granulocytes, Monocytes, and
Macrophages: Poster I. Publication Number: 1147. December 7, 8:30
p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT).
Exposure-Response Relationships for Axatilimab, a Humanized
Monoclonal Antibody Targeting CSF-1R, in Patients with Chronic
Graft-Versus-Host Disease Poster Session: 722. Allogeneic
Transplantation: Acute and Chronic GVHD and Immune Reconstitution:
Poster I. Publication Number: 2140. December 7, 8:30 p.m. – 10:30
p.m. ET (5:30 p.m. – 7:30 p.m. PT).
Real-World Patient Characteristics and Treatment Patterns in
Patients with Chronic Graft-Versus-Host Disease Receiving
Belumosudil in the United States Poster Session: 722.
Allogeneic Transplantation: Acute and Chronic GVHD and Immune
Reconstitution: Poster II. Publication Number: 3522. December 8,
9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT).
Ponatinib The Impact of Ponatinib on Pregnancy
Outcomes Poster Session: 908. Outcomes Research: Myeloid
Malignancies: Poster I. Publication Number: 2435. December 7, 8:30
p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT).
Long-Term Safety and Effectiveness of Ponatinib Treatment in
Patients with TKI Intolerance: Subgroup Analysis of the
Observational Study of Ponatinib Treatment in Patients with CML in
Italy (OITI) Poster Session: 908. Outcomes Research: Myeloid
Malignancies: Poster I. Publication Number: 2427. December 7, 8:30
p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT).
Ponatinib Safety Profile: An Analysis of 10-Years of
Real-World Experience Poster Session: 908. Outcomes Research:
Myeloid Malignancies: Poster II. Publication Number: 3816. December
8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT).
INCB057643 Machine Learning in Predicting Longitudinal
Platelet Counts: Applications in Dose Optimization Poster
Session: 803. Emerging Tools, Techniques, and Artificial
Intelligence in Hematology: Poster III. Publication Number: 4985.
December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m.
PT).
More information regarding the 2024 ASH Annual Meeting can be
found on their website:
https://www.hematology.org/meetings/annual-meeting/schedule-and-program.
All sessions will be broadcast virtually, and access to the
meeting’s virtual platform is included with registration.
Conference Call and Webcast Incyte will hold a conference
call and webcast on Thursday, December 12, 2024, from 4:00-5:00
p.m. ET, to discuss key data presentations at ASH, including data
from the Phase 3 inMIND study presented during the late breaking
session and its BET inhibitor program.
To access the conference call, please dial 877-407-3042 for
domestic callers or 201-389-0864 for international callers. When
prompted, provide the conference identification number,
13750244.
If you are unable to participate, a replay of the conference
call will be available for thirty days. The replay dial-in number
for the United States is 877-660-6853 and the dial-in number for
international callers is 201-612-7415. To access the replay, you
will need the conference identification number, 13750244.
The live webcast with slides can be accessed at
Investor.Incyte.com and will be available for replay for ninety
days.
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 a registered trademark of Incyte.
About Monjuvi® (tafasitamab-cxix) Monjuvi®
(tafasitamab-cxix) 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 Zynyz® (retifanlimab-dlwr) Zynyz®
(retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in
the U.S. for the treatment of adult patients with metastatic or
recurrent locally advanced Merkel cell carcinoma (MCC). This
indication is approved under accelerated approval based on tumor
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered
into an exclusive collaboration and license agreement with
MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a registered trademark 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 and the Pemazyre logo are registered trademarks of
Incyte.
* Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE:
Incyte; 2020.
About Niktimvo™ (axatilimab-csfr) Niktimvo™
(axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved
for use in the U.S. for the treatment of chronic graft-versus-host
disease (cGVHD) after failure of at least two prior lines of
systemic therapy in adult and pediatric patients weighing at least
40 kg (88.2 lbs).
In 2016, Syndax licensed exclusive worldwide rights to develop
and commercialize Niktimvo from UCB. In September 2021, Syndax and
Incyte entered into an exclusive worldwide co-development and
co-commercialization license agreement for Niktimvo in cGVHD and
any future indications.
Axatilimab is being studied in frontline combination trials in
chronic GVHD – a Phase 2 combination trial with ruxolitinib
(NCT06388564) and a Phase 3 combination trial with steroids are
expected to initiate by year end. Axatilimab is also being studied
in an ongoing Phase 2 trial in patients with idiopathic pulmonary
fibrosis (NCT06132256).
Niktimvo is a trademark of Incyte. All other trademarks are the
property of their respective owners. Niktimvo (axatilimab-csfr) is
licensed from Syndax.
About Iclusig® (ponatinib) tablets Iclusig® (ponatinib)
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 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 potential
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 September 30, 2024. We disclaim any
intent or obligation to update these forward-looking
statements.
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