INCYTE
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its oncology portfolio will be presented at the upcoming European Hematology Association 2022 (EHA2022) Congress (June 9-17; virtual and in Vienna).
“We are committed to advancing science that can lead to solutions for patients with serious unmet medical needs, including those with cancer,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “For that reason, we look forward to convening with the oncology community and presenting data from across our portfolio, including both Incyte-led and partnered programs.”
Key abstracts accepted by EHA include:
Oral Presentation
Long-term Efficacy and Safety Results from an Ongoing Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #S286. Session: Transfusion and Autoimmune Hemolytic Anemia. Session Time: Friday, June 10, 11:30 a.m. - 12:45 p.m.)
Poster Presentations
A Real-World Evaluation of the Association Between Elevated Blood Counts and Thrombotic Events in Polycythemia Vera: An Analysis of Data from the Reveal Study (Abstract #P1062. Session: Myeloproliferative neoplasms – Clinical)
Does Early Intervention in Myelofibrosis Impact Outcomes? A Pooled Analysis of the COMFORT 1 and 2 Studies (Abstract #P1037. Session: Myeloproliferative neoplasms - Clinical)
Ruxolitinib Demonstrates a Greater Corticosteroid-Sparing Effect than Best Available Therapy in Patients with Corticosteroid-Refractory/Dependent Chronic Graft-Vs-Host Disease1 (Abstract #P1389. Session: Stem cell transplantation - Clinical)
Real-World Safety of Ruxolitinib in Patients with Intermediate or High Risk of Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis in China1 (Abstract #P1047. Session: Myeloproliferative neoplasms - Clinical)
Efficacy and Safety of Parsaclisib-Ruxolitinib Combination Therapy in Myelofibrosis Patients with Low vs Higher Baseline Platelet Count: A Subgroup Analysis of Data from a Phase 2 Study (Abstract #P1063. Session: Myeloproliferative neoplasms - Clinical)
A Phase 1 Study Evaluating Safety and Efficacy of Parsaclisib in Combination with Bendamustine + Obinutuzumab in Patients with Relapsed or Refractory Follicular Lymphoma (CITADEL-102) (Abstract #P1104. Session: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical)
A Phase 1 Study of Parsaclisib in Combination with Investigator Choice of Rituximab, Bendamustine + Rituximab, or Ibrutinib in Patients with Previously Treated B-Cell Lymphoma (CITADEL-112): Preliminary Safety Results (Abstract #P1102. Session: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical)
inMIND : A Phase 3 Study of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo Plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) (Abstract #P1103. Session: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical)
Real-Life Effectiveness and Safety Outcomes of Ponatinib Treatment in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (PH+ALL): 5-Year-Data from a Belgian Registry (Abstract #P699. Session: Chronic myeloid leukemia - Clinical)
Dose Modification Dynamics of Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) from the PACE and OPTIC Trials2 (Abstract #P707. Session: Chronic myeloid leukemia - Clinical)
All (e)Poster presentations will be made available as of Friday, June 10, 2022, at 3:00 a.m. EST and will be accessible for on-demand viewing until Monday, August 15, 2022, on the Congress platform. For full session details and data presentation listings, please see the EHA2022 online program (https://ehaweb.org/congress/eha2022-hybrid/eha2022-congress/ ).
About Ruxolitinib (Jakafi®
)
Ruxolitinib (Jakafi®
) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for 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, for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older and for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi® (ruxolitinib) outside the U.S. Jakafi is a registered trademark of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the U.S.
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).
In the United States, 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 DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results in a confirmatory trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S. and marketed by Incyte under the brand name Minjuvi® in the EU.
XmAb® is a registered trademark of Xencor, Inc.
About Ponatinib (Iclusig®
) 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 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.
Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.
Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
About Parsaclisib
Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in non-Hodgkin lymphomas and autoimmune hemolytic anemia, and in combination with ruxolitinib and tafasitamab for myelofibrosis and non-Hodgkin lymphomas, respectively.
In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.
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; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the U.S. FDA and other regulatory authorities outside of the United States; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended March 31, 2022. The Company disclaims any intent or obligation to update these forward-looking statements.
_________________________________________
1
Novartis-sponsored abstract
2
Takeda-sponsored abstract
View source version on businesswire.com: https://www.businesswire.com/news/home/20220526005194/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
CoMotion GLOBAL 2025 Launches in Riyadh: Global Mobility Leaders Unite in Saudi Capital to Chart Urban Future7.12.2025 13:00:00 CET | Press release
Summit debuts Mayors in Motion initiative and CoMotion Urban Visionary Distinction as Riyadh showcases its rise as global mobility testbed Riyadh is rapidly becoming one of the world's most ambitious urban mobility laboratories, where next-generation technologies move from blueprint to real-world deployment on city streets at unprecedented scale. CoMotion GLOBAL 2025, the world's most influential gathering of urban mobility leaders, opens today in Riyadh for a three-day summit bringing together innovators from Africa, Asia, Europe, the Americas, and the Middle East. Running December 7-9, the event will explore how electrification, autonomy, AI-enabled transport, and giga-project urbanism are reshaping cities worldwide. The summit will spotlight everything from high-performance EVs and breakthrough autonomous fleets to emerging-market transport solutions and new mobility models, demonstrating how the Kingdom is opening new pathways for global mobility leadership. Strategic Partnerships
Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67th American Society of Hematology (ASH) Annual Meeting6.12.2025 15:30:00 CET | Press release
Results from Phase 2a IMPRSSION study demonstrate sapablursen significantly reduced phlebotomy rate, controlled hematocrit and increased serum hepcidin Sapablursen was generally safe and well tolerated Results support further development of sapablursen in a Phase 3 study Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which On
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 15:30:00 CET | Press release
52-Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety SignalsThese Data Build on Positive 32-Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary EndpointsPatients Crossing Over from Placebo to Rusfertide at 32 Weeks Achieved a Similar Response Rate to Those Initially Randomized to Rusfertide, with 77.9% Achieving Absence of Phlebotomy Eligibility Between Weeks 40-52Four-Year Results from the Combined REVIVE and Long-Term Extension THRIVE Study Demonstrated a 13-Fold Reduction in Annual Rate of Phlebotomies from Baseline Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society
Vertex Presents New Data on CASGEVY®, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory Submissions6.12.2025 13:01:00 CET | Press release
- Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients -- Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older -- Vertex expects to initiate global regulatory submissions for CASGEVY in children 5-11 years in 1H 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and
Leading Global Scientists Gather at Tengchong Scientists Forum to Explore Innovative Pathways in Frontier Technologies6.12.2025 12:31:00 CET | Press release
The 2025 Tengchong Scientists Forum opened on Saturday in southwest China’s Yunnan Province, convening leading scientists and academic figures to examine innovation across frontier fields including artificial intelligence, biodiversity and quantum technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205499197/en/ Opening ceremony of Tengchong Scientists Forum on 6th December, 2025 Notable participants include Nobel Physics laureate Konstantin Novoselov, Fields Medalist Efim Zelmanov and Turing Award winner Andrew Chi-Chih Yao, who join 127 academicians, 77 university presidents from China and abroad, over 400 scholars and more than 600 entrepreneurs and financiers. The gathering aims to deepen collaboration between cutting-edge research and industrial development. Under the theme “Science · AI changing the World,” the forum features ten sub-forums, academic sessions and thematic events supporting major cooperation p
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom