On November 3, 2025 Incyte (Nasdaq:INCY) reported that data from key programs in its oncology portfolio will be presented in both oral and poster sessions at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 6 – 9, 2025, in Orlando.
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"This year’s Incyte presentations highlight the potential of our portfolio to transform the treatment of blood cancers, specifically for patients with myeloproliferative neoplasms (MPNs)," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "New data for our first-in-class mutCALR-targeted monoclonal antibody, INCA033989, as a monotherapy in patients with myelofibrosis (MF) who are intolerant or refractory to ruxolitinib, and in combination with ruxolitinib in patients with MF who experience a suboptimal response to ruxolitinib monotherapy will be highlighted as an oral presentation. Updated data for INCA033989 in essential thrombocythemia (ET) will also be presented. Additionally, we look forward to sharing the results from axatilimab in graft-versus-host disease (GVHD) and tafasitamab in follicular lymphoma (FL) – all of which showcase the progress and promise of our oncology portfolio."
Details on Incyte data presentations at ASH (Free ASH Whitepaper) include:
Oral Presentations
INCA033989 (mutCALR)
Molecular Characterization Of Patients (Pts) With Myeloproliferative Neoplasms Treated With INCA033989 Demonstrates Selective Targeting Of CALR Mutant Hematopoietic Cells
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Precision Targeting in MPN. [December 6, 9:30 – 11:00 a.m. ET]. Publication #71.)
Safety And Efficacy Of The Mutant Calreticulin-Specific Monoclonal Antibody INCA033989 As Monotherapy Or In Combination With Ruxolitinib In Patients (Pts) With Myelofibrosis (MF): Preliminary Results From Dose Escalation Of Two Global Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Between a Rock and a Ropeg – Innovative Therapies for MPNs. [December 7, 9:30 – 11:00 a.m. ET]. Publication #484.)
Safety And Efficacy Of INCA033989, A Novel First In Class Mutant Calreticulin-Specific Monoclonal Antibody, In Patients With Essential Thrombocythemia
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Drivers and Mast Cells and Blasts, Oh My! – Insights and Treatments for MPNs and Mastocytosis. [December 8, 4:30 – 6:00 p.m. ET]. Publication #1024.)
Axatilimab (Niktimvo)
Safety And Feasibility Of 0.6 mg/kg Every 4 Weeks Dosing Of Axatilimab In Patients Treated In The AGAVE-201 Study
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Acute and Chronic GVHD and Immune Reconstitution. [December 6, 2:00 – 3:30 p.m. ET]. Publication #272.)
INCB057643 (BET)
Safety And Efficacy Of Bromodomain And Extra-Terminal Protein Inhibitor INCB057643 Monotherapy In Patients With Relapsed Or Refractory Myelofibrosis And Other Advanced Myeloid Neoplasms: A Phase 1 Study
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Beyond JAK Inhibition – Therapeutic Innovation and Transplant Strategies in Myelofibrosis. [December 8, 2:45 – 3:00 p.m. ET]. Publication #907)
Ruxolitinib (Jakafi)
Risk Factors For Progressive Kidney Impairment Among Patients With Polycythemia Vera (PV) Are Recapitulated And Treatable In Mouse Models Of PV
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Treatment and Outcomes in the Real-World. [December 7, 12:00 – 1:30 p.m. ET]. Publication #605.)
Poster Presentations
Axatilimab (Niktimvo)
Pharmacodynamic Analysis Of AGAVE-201 Indicates Changes In CSF-1R–Expressing Cells And Associated Biomarkers Potentially Contributing To Chronic Graft-Versus-Host Disease Resolution
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2458.)
Trial In Progress: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of Axatilimab And Corticosteroids As Initial Treatment For Moderate To Severe Chronic Graft-Versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #4256.)
Long-Term Treatment Duration And Safety Of Axatilimab Among Patients With Chronic Graft-Versus-Host Disease In AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6010.)
Safety Analysis Of Axatilimab In Patients With Chronic Graft-Versus-Host Disease In An Expanded Access Program
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6008.)
Axatilimab In Combination With Ruxolitinib In Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease: Interim Safety Analysis Of A Randomized, Phase 2 Study
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6012.)
INCB000928 (ALK2)
The Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib (INCB000928) As Monotherapy Or With Ruxolitinib In Patients With Anemia Due To Myelofibrosis: Phase 1/2 Study Final Results
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3795.)
INCB057643 (BET)
INCB057643, A Bromodomain And Extra-Terminal Protein Inhibitor, In Combination With Ruxolitinib In Patients With Myelofibrosis: A Phase 1 Study Of Safety And Efficacy
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5574.)
INCB160058 (JAK2V617F)
INCB160058 Selectively Targets JAK2V617F-Driven Hematopoiesis In Diverse And Drug-Resistant Models Of Myeloproliferative Neoplasms
(Session Title: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II. [December 7. 6:00 – 8:00 p.m. ET]. Publication #3275.)
A Multicenter, Open-Label Phase 1 Study Of INCB160058, A First-In-Class JAK2V617F Mutant–Selective Inhibitor, In Patients With Myelofibrosis, Polycythemia Vera, Or Essential Thrombocythemia
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2051.)
Ruxolitinib (Jakafi)
Impact Of Ruxolitinib On Corticosteroid Treatment Patterns In 1147 Patients With Chronic Graft-Versus-Host Disease In Real-World Practice In The United States: A Long-Term Follow-Up Analysis
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2452.)
Clinical And Disease Characteristics Of Initial Participants At Time Of Enrollment In THRIVE, A Prospective, Observational Cohort Study Of Patients At Risk For Chronic Graft-Versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2446.)
Ruxolitinib Duration Of Treatment And Effect On Phlebotomy Use Among 2369 Patients With Polycythemia Vera: A Real-World Analysis Of The Medicare Fee-For-Service Claims Database
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2826.)
Longitudinal Genomic Shifts Associated With Disease Transformation In Patients With Polycythemia Vera (PV) Enrolled In REVEAL
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3749.)
Identification Of Biomarkers To Predict Disease Progression Via Molecular Analysis Of Patients (Pts) With Low-Risk Myelofibrosis (MF) Enrolled In The MOST Study
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5526.)
Real-World Treatment Duration Of Ruxolitinib And Use Of Transfusion Among 2268 Patients With Myelofibrosis: An Analysis Of The Medicare Fee-For-Service Claims Database
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6391.)
Ruxolitinib XR
Bioequivalence Of Ruxolitinib Once-Daily Extended-Release Vs Twice-Daily Immediate-Release Tablets In Healthy Adults
(Session Title: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5045.)
Tafasitamab (Monjuvi)
Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes By Age
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3582.)
Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes Of Patients Receiving Second-Line Treatment
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #1819.)
CD19 Expression Is Preserved Following CD19-Directed Monoclonal Antibody Therapy With Tafasitamab
(Session Title: 629. Aggressive Lymphomas, Immunotherapy Including Bispecific Antibodies: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5515.)
Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes Of High-Risk Patients
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5367.)
All regular abstracts accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting 2025 are available online via the ASH (Free ASH Whitepaper) website. More information regarding the 2025 ASH (Free ASH Whitepaper) Congress can be found at: View Source
Conference Call and Webcast
Incyte will host an investor event and webcast on Sunday, December 7, 2025, from 11:00 a.m.-12:30 p.m. ET to discuss key mutCALR data being presented at ASH (Free ASH Whitepaper).
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.
(Press release, Incyte, NOV 3, 2025, View Source [SID1234659307])