- Numerous abstracts, including 7 oral
presentations, highlighting data for ruxolitinib, parsaclisib,
tafasitamab and ponatinib to be exhibited
Incyte (Nasdaq: INCY) today announced that numerous abstracts
highlighting data from its oncology portfolio will be presented at
the upcoming 62nd American Society of Hematology Annual Meeting and
Exposition (ASH 2020), held virtually December 5–8, 2020.
“We are thankful for the American Society of Hematology’s
efforts to hold ASH 2020 – a key event for the scientific community
– virtually, and are proud the Incyte portfolio will be represented
in more than 40 abstracts,” said Steven Stein, M.D., Chief Medical
Officer, Incyte. “The presentations, including the oral
presentation of the Phase 3 REACH3 study for ruxolitinib in chronic
graft-versus-host disease (GVHD), reflect the strength of our
diverse oncology portfolio and our partnerships, and reinforce our
commitment to finding solutions that can improve the lives of
patients with multiple rare cancers and serious conditions where
there is significant medical need.”
Select key abstract presentations from Incyte-developed and
partnered programs include:
Oral Presentations
Ruxolitinib: Graft-Versus-Host Disease (GVHD)
Ruxolitinib vs Best Available Therapy in Patients with
Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease
(cGVHD): Primary Findings from the Phase 3, Randomized REACH3
Study1 (Abstract #77, Session: 732. Clinical Allogeneic
Transplantation: Results I. Saturday, December 5, 7:30-9:00 a.m.
PT)
Ruxolitinib: Myeloproliferative Neoplasms (MPN)
To Treat or Not To Treat? Understanding Treatment Patterns in
Patients with Lower-Risk Myelofibrosis Enrolled in the MOST
Study (Abstract #152, Session: 904. Outcomes Research –
Non-Malignant Conditions: Bleeding, Immune Thrombocytopenia, and
Other Hematologic Disorders. Saturday, December 5, 9:30-11:00 a.m.
PT)
Mortality and Causes of Death of Patients with Polycythemia
Vera: Analysis of the REVEAL Prospective, Observational Study
(Abstract #484, Session: 634. Myeloproliferative Syndromes:
Clinical: Clinical Trials in Polycythemia Vera. Sunday, December 6,
2:00-3:30 p.m. PT)
Parsaclisib
Phase 2 Study Evaluating the Efficacy and Safety of
Parsaclisib in Patients with Relapsed or Refractory Marginal Zone
Lymphoma (CITADEL-204) (Abstract #338, Session: 623. Mantle
Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Clinical studies in Waldenstrom's Macroglobulinemia,
Marginal Zone Lymphoma and Hairy Cell Leukemia. Sunday, December 6,
9:30-11:00 a.m. PT)
Ponatinib
Outcome by Mutation Status and Line of Treatment in OPTIC, a
Dose-Ranging Study of 3 Starting Doses of Ponatinib in Patients
with CP-CML2 (Abstract #48, Session: 632. Chronic Myeloid
Leukemia: Therapy—Building The Future CML. Saturday, December 5,
7:30-9:00 a.m. PT)
Efficacy and Safety of Ponatinib (PON) in Patients with
Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Who Failed One or
More Second-Generation (2G) Tyrosine Kinase Inhibitors (TKIs):
Analyses Based on PACE and OPTIC2 (Abstract #647, Session: 632.
Chronic Myeloid Leukemia: Therapy: CML: New and Beyond. Monday,
December 7, 11:30 a.m.-1:00 p.m. PT)
Itacitinib
A Single-Arm, Open-Label, Phase 1 Study of Itacitinib (ITA)
with Calcineurin Inhibitor (CNI)-Based Interventions for
Prophylaxis of Graft-Versus-Host Disease (GVHD; GRAVITAS-119)
(Abstract #356, Session: 722. Clinical Allogeneic Transplantation;
Acute and Chronic GvHD, Immune Reconstitution: Phase I and II
Trials. Sunday, December 6, 9:30-11:00 a.m. PT)
Poster Presentations All
accepted posters in Poster I and Poster II sessions are available
from 7:00 a.m.-3:30 p.m. PT on Saturday and Sunday, December 5 and
6. All accepted posters in the Poster III sessions are available
from 7:00 a.m.-3:00 p.m. PT on Monday, December 7.
Ruxolitinib: Graft-Versus-Host Disease (GVHD)
Biomarker Analysis in Patients with Steroid-Refractory Acute
Graft-Versus-Host Disease (aGVHD) Treated with Ruxolitinib (RUX) or
Best Available Therapy (BAT) in the Randomized, Phase 3 REACH2
Study1 (Abstract #1519, Session: 732. Clinical Allogeneic
Transplantation: Results: Poster I. Saturday, December 5)
Ruxolitinib, a JAK1/2 Inhibitor, is Efficacious in a Novel
Humanized GVHD Model Characterized by Enhanced NK, NK-T and T-Cell
Engraftment (Abstract #1422, Session: 701. Experimental
Transplantation: Basic Biology, Pre-Clinical Models: Poster I.
Saturday, December 5)
Safety Analysis of Patients Who Received Ruxolitinib for the
Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease
in an Expanded Access Program (Abstract #1488, Session: 722.
Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune
Reconstitution: Poster I. Saturday, December 5)
Safety Analysis of Ruxolitinib (RUX) vs. Best Available
Therapy (BAT) in Patients (pts) with Steroid-Refractory (SR) Acute
Graft-Versus-Host Disease (aGVHD) in the Randomized Phase 3 REACH2
Study1 (Abstract #2440, Session: 732. Clinical Allogeneic
Transplantation: Results: Poster II. Sunday, December 6)
Ruxolitinib: Myeloproliferative Neoplasms (MPN)
An International Multicentric Observational Study on the Use
of Ruxolitinib in Patients with Polycythemia Vera Resistant or
Intolerant to Hydroxyurea: Results from Interim Analysis1
(Abstract #1256, Session: 634. Myeloproliferative Syndromes:
Clinical: Poster I. Saturday, December 5)
Clinical Characteristics and Treatment Patterns by Risk
Stratification in Patients with Essential Thrombocythemia: An
Analysis of the MOST Study (Abstract #1258, Session: 634.
Myeloproliferative Syndromes: Clinical: Poster I. Saturday,
December 5)
The Final Analysis of EXPAND: A Phase 1b, Open-Label,
Dose-Finding Study of Ruxolitinib (RUX) in Patients (pts) with
Myelofibrosis (MF) and Low Platelet (PLT) Count (50 × 109/L to <
100 × 109/L) at Baseline1 (Abstract #1252, Session: 634.
Myeloproliferative Syndromes: Clinical: Poster I. Saturday,
December 5)
Thrombotic Events and Mortality Risk in Patients Newly
Diagnosed with Intermediate- to High-Risk Essential Thrombocythemia
in the United States (Abstract #1622, Session: 904. Outcomes
Research – Non-Malignant Conditions: Poster I. Saturday, December
5)
Changes in the Incidence and Overall Survival of Patients
with Myeloproliferative Neoplasms Between 2002 and 2016 in the
United States (Abstract #2160, Session: 634. Myeloproliferative
Syndromes: Clinical: Poster II. Sunday, December 6)
Clinical & Economic Implications of Hydroxyurea
Intolerance in Polycythemia Vera in Routine Clinical Practice1
(Abstract #2477, Session: 901. Health Services
Research-Non-Malignant Conditions: Poster II. Sunday, December
6)
Interactions of Key Hematological Parameters with Red Cell
Distribution Width (RDW) are Associated with Incidence of
Thromboembolic Events (TEs) in Polycythemia Vera (PV) Patients: A
Machine Learning Study (PV-AIM)1 (Abstract #2991, Session: 634.
Myeloproliferative Syndromes: Clinical: Poster III. Monday,
December 7)
Long-Term Effect of Ruxolitinib (RUX) in Inadequately
Controlled Polycythemia Vera (PV) Without Splenomegaly: 5-Year
Results from the Phase 3 Response-2 Study1 (Abstract #2987,
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical
Studies: Poster III. Monday, December 7)
Real-World Survival Among Patients with Intermediate- to
High-Risk Myelofibrosis in the United States: Impact of Ruxolitinib
Approval (Abstract #3089, Session: 634. Myeloproliferative
Syndromes: Clinical: Poster III. Monday, December 7)
Thrombosis and Risk of Mortality in Newly Diagnosed High-Risk
Polycythemia Vera: An Analysis of the Medicare Claims Database in
the United States (Abstract #3458, Session: 904. Outcomes
Research—Non-Malignant Conditions: Poster III. Monday, December
7)
ADORE: A Randomized, Open-Label, Phase 1/2 Open-Platform
Study Evaluating Safety and Efficacy of Novel Ruxolitinib
Combinations in Patients with Myelofibrosis1 (Abstract #2997,
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical
Studies: Poster III. Monday, December 7)
Parsaclisib
Phase 2 Study Evaluating the Efficacy and Safety of
Parsaclisib in Patients with Relapsed or Refractory Mantle Cell
Lymphoma Not Previously Treated with a BTK Inhibitor
(CITADEL-205) (Abstract #1121, Session: 623. Mantle Cell,
Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies:
Poster I. Saturday, December 5)
Phase 2 Study Evaluating the Efficacy and Safety of
Parsaclisib in Patients with Relapsed or Refractory Mantle Cell
Lymphoma Previously Treated with Ibrutinib (CITADEL-205)
(Abstract #2044, Session: 623. Mantle Cell, Follicular, and Other
Indolent B-Cell Lymphoma—Clinical Studies: Poster II. Sunday,
December 6)
Phase 2 Study Evaluating the Efficacy and Safety of
Parsaclisib in Patients with Relapsed or Refractory Follicular
Lymphoma (CITADEL-203) (Abstract #2935, Session: 623. Mantle
Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Poster III. Monday, December 7)
Ponatinib
Ponatinib Versus Imatinib with Reduced-Intensity Chemotherapy
in Patients with Newly Diagnosed Philadelphia Chromosome–Positive
(Ph+) Acute Lymphoblastic Leukemia (ALL): PhALLCON Study2
(Abstract #1026, Session: 615. Acute Myeloid Leukemia: Commercially
Available Therapy, excluding Transplantation: Poster I. Saturday,
December 5)
A Phase 1/2 Study to Evaluate the Safety and Efficacy of
Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia
Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)2
(Abstract #2842, Session: 614. Acute Lymphoblastic Leukemia:
Therapy, excluding Transplantation: Poster III. Monday, December
7)
Treatment of Newly Diagnosed Philadelphia Chromosome Positive
Acute Lymphoblastic Leukemia Using Tyrosine Kinase Inhibitors in
Combination with Chemotherapy: A Patient-Centered Benefit-Risk
Assessment2 (Abstract #3471, Session: 905. Outcomes
Research—Malignant Conditions (Lymphoid Disease): Poster III.
Monday, December 7)
Tafasitamab
The Combination of Tafasitamab and Rituximab Increases
Cytotoxicity Against Lymphoma Cells In Vitro3 (Abstract #2095,
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic
Agents: Poster II. Sunday, December 6)
A Phase 1b, Open-label, Randomized Study to Assess Safety and
Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab +
Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed
Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-In
Phase3 (Abstract #3028, Session: 626. Aggressive Lymphoma
(Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin
Lymphomas)—Results from Prospective Clinical Trials: Poster III.
Monday, December 7)
Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of
Tafasitamab (MOR208) Combined with Lenalidomide in Patients with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma3 (Abstract
#3021, Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and
Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from
Prospective Clinical Trials: Poster III. Monday, December 7)
Blockade of the CD47/SIRPα Checkpoint Potentiates the
Anti-Tumor Efficacy of Tafasitamab3 (Abstract #3008, Session:
625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents:
Poster III. Monday, December 7)
INCB057643
A Phase 1 Study of INCB057643 Monotherapy in Patients with
Relapsed or Refractory Myelofibrosis (INCB57643-103) (Abstract
#2166, Session: 634. Myeloproliferative Syndromes: Clinical: Poster
II. Sunday, December 6)
INCB000928
A Phase 1/2 Study of INCB000928 as Monotherapy or in
Combination with Ruxolitinib in Patients with Anemia Due to
Myelofibrosis (INCB00928-104) (Abstract #3000, Session: 634.
Myeloproliferative Syndromes: Clinical: Poster III. Monday,
December 7)
Characterization of INCB000928, a Potent and Selective ALK2
Inhibitor for the Treatment of Anemia (Abstract #3095, Session:
635. Myeloproliferative Syndromes: Basic Science: Poster III.
Monday, December 7)
Full session details and listings for oral presentations and
poster sessions are available in the ASH 2020 program:
https://ash.confex.com/ash/2020/webprogram/start.html.
About Jakafi® (ruxolitinib) Jakafi is a first-in-class
JAK1/JAK2 inhibitor approved by the U.S. FDA for the 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 and
for the treatment of steroid-refractory acute GVHD 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 Iclusig® (ponatinib) Tablets 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.
Iclusig is approved in the U.S., EU, UK, Australia, Switzerland,
Israel and Canada. 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.
About Monjuvi® (tafasitamab-cxix) 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).
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).
In January 2020, MorphoSys and Incyte entered into a
collaboration and licensing agreement to further develop and
commercialize tafasitamab globally. Monjuvi is being
co-commercialized by Incyte and MorphoSys in the United States.
Incyte has exclusive commercialization rights outside the United
States.
A marketing authorization application (MAA) seeking the approval
of tafasitamab in combination with lenalidomide in the EU has been
validated by the European Medicines Agency (EMA) and is currently
under review for the treatment of adult patients with relapsed or
refractory DLBCL, including DLBCL arising from low grade lymphoma,
who are not candidates for ASCT.
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in a number of ongoing combination
trials.
Monjuvi® is a registered trademark of MorphoSys AG. XmAb® is a
registered trademark of Xencor, 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 the Company’s oncology development portfolio, alone and in
conjunction with its collaboration partners; whether or when any
such compounds will be approved or commercially available for use
in humans anywhere in the world or will improve the lives of
patients; and the likelihood of continued approval of Monjuvi in
DLBCL in the U.S. and whether it will also be approved by the EMA,
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; determinations made by the FDA or the EMA; the efficacy or
safety of the Company’s products; the acceptance of the Company’s
products and the products of the Company’s collaboration partners
in the marketplace; market competition; sales, marketing,
manufacturing and distribution requirements; greater than expected
expenses; expenses relating to litigation or strategic activities;
and other risks detailed from time to time in the Company’s reports
filed with the Securities and Exchange Commission, including its
Form 10-Q for the quarter ended September 30, 2020. The Company
disclaims any intent or obligation to update these forward-looking
statements.
1 Novartis-sponsored abstract. 2 Takeda-sponsored abstract. 3
MorphoSys-sponsored abstract.
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Incyte Contacts Media
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Nupur Patel, PharmD +1 302 498 5822 npatel@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
Christine Chiou +1 302 274 4773 cchiou@incyte.com
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