DE-INCYTE
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) 2021 Virtual Congress, held virtually from June 9-17, 2021.
“We are pleased that data highlighting the strength of Incyte’s oncology portfolio and partner-sponsored programs will be presented at this year’s EHA Virtual Congress,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. “In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia; an oral presentation on real-world data for ruxolitinib, our JAK1/JAK2 inhibitor; and an ePoster from our Phase 2 combination study of ruxolitinib and parsaclisib in patients with myelofibrosis – reinforce our commitment to finding solutions for patients with significant unmet medical needs.”
Key abstracts accepted by EHA include:
Oral Presentations
Ponatinib
OPTIC Primary Analysis: A Dose-Optimization Study of 3 Starting Doses of Ponatinib (PON)1 (Abstract #S153. Session: Response, Resistance and Treatment-Free Remission in CML.)
Ruxolitinib
Efficacy and Safety of Ruxolitinib in Patients with Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in the Phase 3 REACH2 Study2 (Abstract #S236. Session: Stem cell transplantation – GvHD.)
Impact of Ruxolitinib on Survival of Patients with Myelofibrosis in Real World – Update of ERNEST (European Registry for Myeloproliferative Neoplasms) Study2 (Abstract #S158. Session: Population based studies in myeloid disorders.)
ePosters
Parsaclisib
Efficacy and Safety Results from an Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP685. Session: Enzymopathies, Membranopathies and Other Anemias.)
Pharmacologic Inhibition of PI3kδ Reduces Autoantibody Formation and is Efficacious in a Preclinical Model of Autoimmune Hemolytic Anemia (Abstract #EP693. Session: Enzymopathies, Membranopathies and Other Anemias.)
FACIT-Fatigue Subscale Outcomes from an Ongoing Phase 2, Open-Label Study of the Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor Parsaclisib in Patients with Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP706. Session: Enzymopathies, Membranopathies and Other Anemias.)
Ponatinib
French Real-Life Observational Study “TOPASE” Evaluating Safety and Efficacy of Ponatinib Confirms Induction of Deep Molecular Responses in 110 Resistant or Intolerant CML Patients (Abstract #EP679. Session: Chronic Myeloid Leukemia – Clinical.)
Ruxolitinib
An Epidemiological Study of the Cardiovascular Health and Thrombotic Risk Profiles of Patients with Myeloproliferative Neoplasms in Primary Care Across the United Kingdom2 (Abstract #EP1090. Session: Myeloproliferative Neoplasms – Clinical.)
Impact of Bone Marrow Fibrosis Grade on Response and Outcome in Patients with Primary Myelofibrosis Treated with Ruxolitinib: A Post-Hoc Analysis of the JUMP Study2 (Abstract #EP1092. Session: Myeloproliferative Neoplasms – Clinical.)
Healthcare Resource Utilization in Patients with Myeloproliferative Neoplasms: A Nationwide Matched Cohort Study2 (Abstract #EP1107. Session: Myeloproliferative Neoplasms – Clinical.)
Ruxolitinib-Parsaclisib Combination Studies
Add-On Parsaclisib (a PI3kδ inhibitor) in Patients with Myelofibrosis and Suboptimal Response to Ruxolitinib: Interim Analysis from a Phase 2 Study (Abstract #EP1075. Session: Myeloproliferative Neoplasms – Clinical.)
Tafasitamab
Estimation of Long-Term Survival with Tafasitamab + Lenalidomide in Relapsed/Refractory Diffuse Large B-Cell Lymphoma3 (Abstract #EP553. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)
First-MIND: 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 DLBCL3 (Abstract #EP496. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)
Lenalidomide-Induced Effects on Cell Surface Expression of CD19 and CD20 in DLBCL Cell Lines and Functional Impact on Antibody-Mediated Cytotoxicity3 (Abstract #EP879 . Session: Lymphoma Biology & Translational Research.)
In addition to the presentations noted above, more than 10 publications highlighting data from Incyte’s portfolio will be made available by EHA as publications. Notably, these publications include bioequivalence and bioavailability data for ruxolitinib’s once-daily extended release (XR) formulation – Bioequivalence of 50 mg Once-Daily Ruxolitinib Extended Release (XR) Tablets Compared to 25 mg Twice-Daily Ruxolitinib Immediate Release (IR) Tablets (Abstract #PB1706) and Relative Bioavailability and Dose Linearity of Five Strengths of Ruxolitinib Extended Release (XR) Tablets (Abstract #PB1717).
Full listings for oral presentations and ePoster sessions are available on the EHA website: https://library.ehaweb.org . Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at EHA will be available on demand for registered attendees beginning Friday, June 11, 2021, through Sunday, August 15, 2021.
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 or partner company’s ongoing clinical development pipeline, and 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, its presentation plans for the upcoming EHA meeting and its goal of improving the lives of patients, 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 and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers, and development and discovery operations; determinations made by the FDA and other regulatory authorities outside of the United States; the Company’s dependence on its relationships with its collaboration partners; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended March 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
________________
1
Takeda-sponsored abstract.
2
Novartis-sponsored abstract.
3
MorphoSys-sponsored abstract.
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