Business Wire

Data From Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 EHA Virtual Congress

Share

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media
Catalina Loveman
+1 302 498 6171
cloveman@incyte.com

Investors
Christine Chiou
+1 302 274 4773
cchiou@incyte.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Celltrion Healthcare presents the first real-world data for Truxima ® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress12.6.2021 17:45:00 CEST | Press release

Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.1 CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin’s lymphoma (NHL).2 DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.3,4,5,6 This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment t

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® ▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible12.6.2021 09:01:00 CEST | Press release

The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® ▼(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and will be presented as a late-breaking abstract during the EHA Virtual Congress (Abstract #LB1901). The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.1 Median OS was not reached in either arm [hazard ratio (HR): 0.68, 95 percent confidence interval (CI),

New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia12.6.2021 09:00:00 CEST | Press release

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukaemia (CLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission.1 With I+V, undetectable minimal residual disease (uMRD) in peripheral blood (PB) was sustained by 85 percent of patients one year after end of treatment.1 The safety and tolerability profile of I+V was consistent with CLL treatment in an older population with comorbidities.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing an

Alluzience ® , the first ready-to-use BoNT-A neuromodulator, receives positive decision for use in Europe11.6.2021 11:53:00 CEST | Press release

Galderma today announced that Alluzience® has completed its European decentralized procedure resulting in a positive decision for the first ready-to-use neuromodulator, a wrinkle relaxing injection, in Europe. National approvals will now take place across the region in line with local processes in each country. Designed for precision, Alluzience® is a liquid form of botulinum toxin type A intended for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows), when the severity of these lines has an important psychological impact on the patient.1 "The introduction of Alluzience® marks a new era in treatment innovation for upper facial lines in Europe. Like many aspects of physical appearance, glabellar lines can have a significant impact on patients’ confidence and wellbeing. I’ve heard first-hand that the transition to living and working in a virtual world has only exacerbated these issues. As

Secure Communities Forum: Behavioural Insights Can Assist Governments in the Post-Pandemic World11.6.2021 10:15:00 CEST | Press release

The Secure Communities Forum, a global collaboration of security professionals, has convened a leading panel of experts to discuss how behavioural science can impact positive social cohesion, build on the concept of positive citizenship, and encourage positive individual behaviours. The virtual event was attended by 134 people from 18 countries. The Secure Communities Forum convened the webinar in response to the ongoing Covid-19 pandemic. Governments and law enforcement agencies have used behavioural science to encourage adherence to public health measures like social distancing and mask-wearing. Lindsay Juarez, Director at Irrational Labs, USA, opened the session, offering the view that we assume humans are rational, which is not the case. She said: “Behavioural science is about setting people up for success and breaking through the noise. Information isn't enough to change behaviour, the decision-making context matters. “People don’t always act in their own long-term best interests,

Luxembourg’s Supercomputer MeluXina is Operational11.6.2021 09:18:00 CEST | Press release

Luxembourg’s high performance computer MeluXina was officially launched on June 7 putting the country on the global map of computer super powers. MeluXina is capable of executing more than 10 Petaflops, the equivalent of 10 million billion calculations per second, which will rank it among the world’s top 50 supercomputers. The petascale computer is powered by green energy and is part-funded under the European High Performance Computing Joint Undertaking. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005115/en/ Minister of State Xavier Bettel; His Royal Highness Henri, Grand Duke of Luxembourg; Minister of the Economy Franz Fayot; EuroHPC Joint Undertaking Executive Director Anders Jensen (Photo: Business Wire) In a series of 8 high-performance computers in the EU, MeluXina joins Vega, another petascale supercomputer located in Slovenia, as the first EuroHPC machines to go live. Its innovative modular architecture allo

Vertex and CRISPR Therapeutics Present New Data in 22 Patients With Greater Than 3 Months Follow-Up Post-Treatment With Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at European Hematology Association Annual Meeting11.6.2021 09:05:00 CEST | Press release

Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) and CRISPR Therapeutics (Nasdaq:CRSP) today announced new data on 22 patients,with follow-up of at least 3 months, and ranging from 4 months to 26 months, treated with the investigational CRISPR/Cas9-based gene-editing therapy, CTX001, that show a consistent and sustained response to treatment. CTX001 is being investigated in two ongoing Phase 1/2 clinical trials as a potential one-time therapy for patients suffering from transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD). In total, more than 40 patients have been dosed across both studies to date. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005069/en/ All 15 patients with TDT, including six who have the beta zero/beta zero or other severe genotypes, were transfusion-free at last follow-up, and all seven patients with severe SCD were free of vaso-occlusive crises (VOCs) from CTX001 infu