November 2, 2023
– Sixteen oral presentations, as well as a plenary session and poster presentations, highlight new advances across eight of the Company’s medicines
– Plenary Scientific Session will feature the full data from AGAVE-201 evaluating axatilimab, an anti-CSFR-1R monoclonal antibody, in patients with chronic graft-versus-host disease (GVHD)
– Incyte to host an in-person analyst and investor event on Monday, December 11, 2023 from 12:00-1:30 p.m. PT to discuss key data presentations at ASH
WILMINGTON, Del.–(BUSINESS WIRE)–Nov. 2, 2023– Incyte (Nasdaq:INCY) today announced that more than 40 abstracts highlighting data from eight of its hematology and oncology products will be presented at the upcoming 65th American Society of Hematology Annual Meeting 2023 (ASH 2023), held December 9-12, 2023, in San Diego and virtually.
“We have continued to make significant progress in advancing our hematology and oncology pipeline with the goal to deliver better medicines for a range of diseases that have limited treatment options, including myeloproliferative neoplasms (MPNs) and chronic graft-versus-host disease (GVHD),” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We are excited to showcase the depth of our portfolio and clinical progress at this year’s ASH congress. In particular, we look forward to the presentation of the axatilimab AGAVE-201 trial results in patients with chronic GVHD at the Plenary Scientific Session, as well as the numerous oral and poster presentations including new data for our mutant CALR, BET, ALK2 and CK0804 programs in MPNs. Additionally, we are proud that the first presentation of data for INCB160058, our new potentially disease modifying JAK2V617F therapy for patients with MPNs, will be at this year’s meeting.”
Select key abstract presentations from Incyte-developed and partnered programs include:
Plenary Scientific Session
Axatilimab
Safety and Efficacy of Axatilimab at 3 Different Doses in Patients with Chronic Graft-Versus-Host Disease (AGAVE-201)1 (Abstract #1. Plenary Scientific Session. Sunday, December 10, 5:00 p.m. – 7:00 p.m. ET)
Oral Presentations
Ruxolitinib (MPN)
A Real-World Evaluation of Risk Factors for Disease Progression in Patients with Polycythemia Vera (PV) Enrolled in REVEAL (Abstract #385. Session: 906. Outcomes Research – Myeloid Malignancies: Risk Factors and Health Disparities. Saturday, December 9, 7:00 p.m. ET)
Phase 1/2 Study of the Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib (INCB000928, LIMBER-104) as Monotherapy or with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (Abstract #624. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Charting The Future Of MPN Therapies. Sunday, December 10, 8:45 p.m. ET)
Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 (LIMBER-103) in Patients with Relapsed or Refractory Myelofibrosis (R/R MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #750. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Treatment and Outcomes in MPNs. Monday, December 11, 2:45 p.m. ET)
Ruxolitinib (GVHD)
Ruxolitinib in Patients with Chronic Graft-Versus-Host Disease: Three-Year Final Analysis of Efficacy and Safety of the Phase 3 REACH3 Study2 (Abstract #654. Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Innovative Approaches to GVHD Prevention and Treatment. Sunday, December 10, 8:45 p.m. ET)
Tafasitamab
Tafasitamab for the Treatment of Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the U.S. Real-World Setting (Abstract #265. Session: 905. Outcomes Research – Lymphoid Malignancies: Outcomes Research in Lymphoma/CLL: Biomarkers, Dosing Strategies, and Big-Data. Saturday, December 9, 5:00 p.m. ET)
Itacitinib
Itacitinib for the Prevention of Immune Effector Cell Therapy-Associated Cytokine Release Syndrome: Results from the Phase 2 INCB 39110-211 Placebo-Controlled, Randomized Cohort (Abstract #356. Session: 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Prediction and Management of CAR-T Cell Related Toxicity. Saturday, December 9, 7:15 p.m. ET)
INCB160058
Preclinical Evaluation of INCB160058 – A Novel and Potentially Disease-Modifying Therapy for JAK2V617F Mutant Myeloproliferative Neoplasms (Abstract #860. Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Lineage Tracing and Novel Target Discovery. Monday, December 11, 6:00 p.m. ET)
Poster Presentations
Ruxolitinib (MPN)
Effect of New or Worsening Anemia on Clinical Outcomes in 2,233 Patients with Myelofibrosis (MF) Treated with Ruxolitinib in the Expanded-Access JUMP Study (Abstract #5174. Session: 906. Outcomes Research—Myeloid Malignancies: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)
Ruxolitinib Treatment in Polycythemia Vera Results in Reduction in JAK2 Allele Burden in Addition to Improvement in Hematocrit Control and Symptom Burden (Abstract #4553. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)
High Rate of Disease Progression in Patients with Low-Risk Myelofibrosis (MF) Enrolled in the Prospective, Real-World, MOST Study Abstract #3803. Session: 906. Outcomes Research—Myeloid Malignancies: Poster II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)
Progression to Myelofibrosis in Patients with Essential Thrombocythemia: A Real-World Analysis from the Prospective MOST Study (Abstract #2433. Session: 906. Outcomes Research—Myeloid Malignancies: Poster I. Saturday, December 9, 8:30 p.m. – 10:30 p.m. ET)
Clinical and Disease Characteristics of Patients With Myelofibrosis and Essential Thrombocythemia that Harbor a Calreticulin (CALR) Gene Mutation: Subanalysis of the MOST Study (Abstract #3812. Session: 906. Outcomes Research—Myeloid Malignancies: Poster II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)
Comparison of the Enzymatic and Cellular Profiles of Clinical JAK2 Inhibitors for the Treatment of Myelofibrosis (Abstract #4532. Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)
ALK2 and JAK2 Inhibition for Improved Treatment of Anemia in Myelofibrosis Patients: Preclinical Profile of an ALK2 Inhibitor Zilurgisertib in Combination with Ruxolitinib (Abstract #1789. Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster I. Saturday, December 9, 8:30 p.m. – 10:30 p.m. ET)
The Association between Blood Cell Counts and Thrombotic Events in Japanese Patients with Polycythemia Vera: A Retrospective Database Study2 (Abstract #3191. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)
Tafasitamab
Real-World Use of Tafasitamab (tafa) for Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) Among Racial and Ethnic Minorities in the United States (Abstract #2415. Session: 905. Outcomes Research – Lymphoid Malignancies: Poster I. Saturday, December 9, 8:30 – 10:30 p.m. ET)
Tafasitamab in Combination with a CD20xCD3 Bispecific T-cell Engager Significantly Prolongs Survival in Preclinical Lymphoma Models3 (Abstract #2813. Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)
Pemigatinib
Deep and Durable Cytogenetic and Molecular Responses with Pemigatinib in Myeloid/Lymphoid Neoplasms with Fibroblast Growth Factor Receptor 1 Rearrangement: The FIGHT-203 Study (Abstract #4551. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)
Ponatinib
Long-term Results From the OPTIC Trial: A Dose-Optimization Study of 3 Starting Doses of Ponatinib4 (Abstract #3164. Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)
Ponatinib Versus Imatinib in Patients with Newly Diagnosed Ph+ ALL: Subgroup Analysis of the Phase 3 PhALLCON Study4 (Abstract #2871. 614. Acute Lymphoblastic Leukemias: Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)
Itacitinib
Janus Kinase (JAK) 1 Inhibition Results in Significant Changes in Serum Proteins and Peripheral T-Cell Populations that Correlated with Clinical Scores in Chronic Graft-Versus-Host Disease (GVHD) Patients (an Analysis from GRAVITAS-309) (Abstract #2197. Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I. Saturday, December 9, 8:30 – 10:30 p.m. ET)
Axatilimab
Axatilimab Ameliorates Inflammation and Fibrosis by Targeting the Macrophages in a Preclinical Model of Chronic GVHD (Abstract #2540. Session: 201. Granulocytes, Monocytes, and Macrophages: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)
CK0804
A Phase 1b, Open-Label Study of Add on Therapy with CK0804 in Participants with Myelofibrosis and Suboptimal Response to Ruxolitinib5 (Abstract #1813. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 9, 8:30 – 10:30 p.m. ET)
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.