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- Data from pivotal Phase 3 frontMIND trial evaluating tafasitamab (Monjuvi\u00ae<\/sup>\/Minjuvi\u00ae<\/sup>) in first-line diffuse large b-cell lymphoma (DLBCL) selected for prestigious Plenary Abstracts Session<\/i><\/li>\n
- Oral and poster presentations to feature new data for INCA033989, an anti-mutant calreticulin (mutCALR)-directed monoclonal antibody, in patients with myeloproliferative neoplasms (MPNs)<\/i><\/li>\n<\/ul>\n
WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nIncyte (Nasdaq:INCY) today announced that data from key programs in its Hematology and Oncology franchises will be presented at the European Hematology Association (EHA) 2026 Congress, to be held June 11 – 14, 2026, in Stockholm, Sweden.<\/p>\n\n\u201cThe breadth of the data that will be showcased at the 2026 EHA Congress highlights the continued advancement of our Hematology and Oncology pipeline and our focus on delivering differentiated medicines for patients with cancer and hematologic diseases,\u201d said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. \u201cThese presentations include findings from the frontMIND study, which support the U.S. and EU regulatory applications for tafasitamab (Monjuvi\u00ae<\/sup>\/Minjuvi\u00ae<\/sup>) in patients with first-line diffuse large B-cell lymphoma (DLBCL). Additionally, data presentations for INCA033989, which support our Phase 3 trials, demonstrate the steady advancement of this molecularly targeted therapy that has the potential to revolutionize treatment for patients with myeloproliferative neoplasms (MPNs).\u201d<\/p>\n
\nDetails on key data presentations at EHA include:<\/p>\n
Plenary Abstract Session<\/span><\/b><\/p>\n
Tafasitamab<\/i><\/b><\/p>\n
Tafasitamab Plus Lenalidomide and R-CHOP for Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Results From the Phase 3 frontMIND Study
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<\/b>(Plenary Abstract Session. June 13, 6:00 – 7:30 a.m. ET [12:00-1:30 p.m. CEST]. Abstract #S101.)<\/p>\nOral Presentations<\/span><\/b><\/p>\n
INCA033989 (mutCALR)<\/i><\/b><\/p>\n
Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, is Well Tolerated and Achieves Robust Spleen, Anemia, and Molecular Responses in Patients with Myelofibrosis
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<\/b>(Session: Myeloproliferative neoplasms \u2013 Clinical. June 13, 11:15 a.m. \u2013 12:30 p.m. ET [5:15-6:30 p.m. CEST]. Abstract #S216.)<\/p>\nPoster Presentations<\/span><\/b><\/p>\n
INCA033989 (mutCALR)<\/i><\/b><\/p>\n
Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, Produces Clonal Molecular Responses that Correlate with Clinical Responses in Patients with MF
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF884)<\/p>\nMutant Calreticulin-Specific Monoclonal Antibody, INCA033989, is Well Tolerated and Achieves Rapid and Sustained Hematologic and Molecular Responses in Patients with Essential Thrombocythemia (ET)
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<\/b>(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1983)<\/p>\nINCA035784 (mutCALR)<\/i><\/b><\/p>\n
Preclinical Evaluation of INCA035784, a Novel T-Cell\u2013Redirecting Antibody for the Treatment of MutCALR-Driven Myeloproliferative Neoplasms (MPNs)
\n
<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 -7:45 p.m. CEST], Abstract #PF858)<\/p>\nINCA160058 (JAK2V617F)<\/i><\/b><\/p>\n
INCB160058 Selectively Targets JAK2V617F-driven Hematopoiesis in Diverse and Drug-Resistant Models of Myeloproliferative Neoplasms (MPNs)
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 -7:45 p.m. CEST], Abstract #PF872)<\/p>\nAxatilimab<\/i><\/b><\/p>\n
Assessments of Bone Health Among Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab in the AGAVE-201 Trial
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF1151)<\/p>\nAxatilimab in Combination with Ruxolitinib in Patients with Newly Diagnosed Chronic Graft-Versus-Host Disease: Updated Safety Analysis of a Randomized, Phase 2 Study
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<\/b>\u200b<\/b>(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2243)<\/p>\nPonatinib<\/i><\/b><\/p>\n
Efficacy and Safety of Ponatinib in Pediatric Patients With BCR::ABL\u2013Positive Chronic Phase Chronic Myeloid Leukemia (CP-CML): Preliminary Results From the INCB84344-102 Study
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF628)<\/p>\nRuxolitinib<\/i><\/b><\/p>\n
Longitudinal Analysis of Iron Deficiency Markers in Patients with Polycythemia Vera Enrolled in the Prospective Observational REVEAL Study
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF910)<\/p>\nRisk factors for Progressive Kidney Impairment Among Patients with Polycythemia Vera (PV) are Recapitulated and Treatable in Mouse Models of PV
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 CEST], Abstract #PF914)<\/p>\nAI-Quantified Bone Marrow Fibrosis and Megakaryocyte Features Correlate With Driver VAF and Outcomes in the MOST MPN Study
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<\/b>\u200b<\/b>(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST],Abstract #PS1961)<\/p>\nIdentification of Biomarkers to Predict Disease Progression Via Molecular Analysis of Patients (pts) with Low-Risk Myelofibrosis (MF) Enrolled in the MOST Study
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<\/b>(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1970)<\/p>\nTafasitamab<\/i><\/b><\/p>\n
Phase 3 inMIND trial of Tafasitamab (Tafa) plus Lenalidomide (Len) and Rituximab (R) in Relapsed\/Refractory (R\/R) Follicular Lymphoma (FL): Analyses of Biomarkers Predictive of Patient (pt) Response
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF1075)<\/p>\nPhase 3 inMIND Study Of Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Clinical Characteristics and Outcomes of Patients Receiving Second-Line Treatment
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<\/b>(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF948)<\/p>\nPhase 3 inMIND Study of Tafasitamab (Tafa) plus Lenalidomide (Len) and Rituximab (R) for Relapsed or Refractory Follicular Lymphoma (R\/R FL): Outcomes in Patients With or Without High-risk Factors
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<\/b>(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2048)<\/p>\nEffectiveness and Safety of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy After Tafasitamab (Tafa) in Relapsed\/Refractory Diffuse Large B-Cell Lymphoma (R\/R DLBCL): A Real-World Study
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<\/b>(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2089)<\/p>\n\nMore information regarding the EHA 2026 Congress can be found at: https:\/\/ehaweb.org\/connect-network\/eha2026-congress<\/a>.<\/p>\n
About Jakafi\u00ae<\/sup> (ruxolitinib)
\n
<\/b>Jakafi\u00ae<\/sup> (ruxolitinib) is a JAK1\/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.<\/p>\n\nJakafi is a registered trademark of Incyte.<\/p>\n
About Monjuvi\u00ae <\/sup>(tafasitamab-cxix)\/Minjuvi\u00ae <\/sup>(tafasitamab)
\n
<\/b>Monjuvi\u00ae<\/sup> (tafasitamab-cxix)\/Minjuvi\u00ae<\/sup> (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb\u00ae<\/sup> 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). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.<\/p>\n\nIn the U.S., Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).<\/p>\n
\nMonjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.<\/p>\n
\nAdditionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).<\/p>\n
\nIn Europe, Minjuvi(tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.<\/p>\n
\nAdditionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.<\/p>\n
\nIn Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).<\/p>\n
\nXmAb\u00ae<\/sup> is a registered trademark of Xencor, Inc.<\/p>\n
\nMonjuvi and Minjuvi are registered trademarks of Incyte.<\/p>\n
About Niktimvo\u2122 (axatilimab-csfr)
\n
<\/b>Niktimvo\u2122 (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).<\/p>\n\nIn 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.<\/p>\n
\nAxatilimab is being studied in frontline combination trials in chronic GVHD \u2013 a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).<\/p>\n
\nNiktimvo is a trademark of Incyte.<\/p>\n
\nAll other trademarks are the property of their respective owners.<\/p>\n
About Iclusig\u00ae<\/sup> (ponatinib) tablets
\n
<\/b>Iclusig\u00ae <\/sup>(ponatinib), 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 tyrosine kinase inhibitors.<\/p>\n\nIn 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.<\/p>\n
\nIncyte 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.<\/p>\n
About Incyte\u00ae
\n
<\/sup><\/b>Incyte is redefining what\u2019s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.<\/p>\n\nTo learn more, visit Incyte.com<\/a> and Investor.Incyte.com<\/a>. Follow us on social media: LinkedIn<\/a>, X<\/a> and Instagram<\/a>.<\/p>\n
Incyte Forward-Looking Statements<\/b><\/p>\n
\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the data to be presented by Incyte at the 2026 EHA Congress, the advancement of Incyte\u2019s Hematology and Oncology pipeline, expectations regarding regulatory submissions for tafasitamab (Monjuvi\/Minjuvi), the advancement of molecularly targeted therapies such as INCA033989 and the potential for such therapies to revolutionize treatment for patients with myeloproliferative neoplasms and Incyte\u2019s aspirations and goals as set forth under the heading \u201cAbout Incyte\u201d.<\/p>\n
\nActual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including Incyte\u2019s ability to demonstrate the efficacy and safety of its products and product candidates; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte\u2019s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte\u2019s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte\u2019s reliance on third parties and partners; the acceptance of Incyte\u2019s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte\u2019s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.<\/p>\n
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Media
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media@incyte.com
\n<\/a><\/p>\n - Oral and poster presentations to feature new data for INCA033989, an anti-mutant calreticulin (mutCALR)-directed monoclonal antibody, in patients with myeloproliferative neoplasms (MPNs)<\/i><\/li>\n<\/ul>\n
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