More than 50 Abstracts from Incyte’s Robust Oncology Portfolio to be Featured at the 64th ASH Annual Meeting
- Plenary Scientific Session to highlight
- Data from three of the Company’s LIMBER studies evaluating ruxolitinib in combination with parsaclisib and its ALK2 and
“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
Select key abstract presentations from
Plenary Scientific Session
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.
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.
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.
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.
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.
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.
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.
All accepted posters in Poster I sessions are available for in-person participants from
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)
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)
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)
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 (
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)
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
Conference call details will be provided on our website.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the
Jakafi is marketed by
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in
Pemazyre is also the first targeted treatment approved for use in
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
Pemazyre is a trademark of
* Pemazyre® (pemigatinib) [Package Insert].
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).
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
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
Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.
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
1 Novartis-sponsored abstract
2 MorphoSys-sponsored abstract
3 Takeda-sponsored abstract
4 Jakafi (ruxolitinib) tablets: Prescribing Information.
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