\n– frontMIND study evaluating tafasitamab (Monjuvi\u00ae<\/sup>\/Minjuvi\u00ae<\/sup>) in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) selected for the prestigious Plenary Abstracts Session at EHA 2026<\/i><\/p>\n \n– Results showed tafasitamab and lenalidomide plus R-CHOP (Tafa-Len-R-CHOP) significantly prolonged progression-free survival (PFS), reducing risk of disease progression or death by 25%<\/i><\/p>\n \n– Positive trends toward PFS benefit with Tafa-Len-R-CHOP were observed across<\/i>prespecified subgroups, including in patients with centrally confirmed lymphoma subtypes and both cell-of-origin (COO) molecular subtypes<\/i><\/p>\n \n– The frontMIND data support global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL and HGBL<\/i><\/p>\n WILMINGTON, Del.–(BUSINESS WIRE<\/a>)– \nThese data are being highlighted in a prestigious Plenary Abstracts Session at the European Hematology Association (EHA) 2026 Congress, being held June 11 – 14, 2026, in Stockholm, Sweden (Abstract # S101. Plenary Abstract Session. June 13, 6:00 – 7:30 a.m. ET [12:00-1:30 p.m. CEST]). frontMIND results were also recently published in The Lancet<\/i><\/a>.<\/p>\n \n\u201cThese frontMIND data reinforce the potential of Tafa-Len-R-CHOP to meaningfully change the first-line treatment landscape for patients with high-risk DLBCL or HGBL, for which outcomes have remained unchanged for decades,\u201d said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development, Incyte. \u201cWith encouraging efficacy observed across prespecified subgroups regardless of cell-of-origin (COO) molecular subtype, we believe these findings position this therapy as a compelling potential new standard of care and support our continued efforts to bring it to patients who are in need of other efficacious treatment options.\u201d<\/p>\n \nThe results, which build on previously reported<\/a> topline data and also recently announced<\/a> at the 2026 American Society of Clinical Oncology Annual Meeting, showed Tafa-Len-R-CHOP resulted in statistically significant and clinically meaningful improvements in progression-free survival (PFS).<\/p>\n Efficacy Data<\/b><\/p>\n \n\u201cA key goal in frontline treatment is to potentially prevent relapse, and spare patients from requiring additional therapies later. This is particularly meaningful for high-risk DLBCL and HGBL patients, where new treatment approaches are needed,\u201d said Dr. Georg Lenz, University Hospital M\u00fcnster and principal investigator of the frontMIND study. \u201cThe frontMIND results are especially encouraging because the addition of tafasitamab and lenalidomide improved outcomes without compromising delivery of the R-CHOP backbone, which remains fundamental to achieving better outcomes for patients.\u201d<\/p>\n Safety Data \nThe frontMIND data support global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL and HGBL.<\/p>\n About DLBCL About frontMIND \nThe study enrolled 899 adults (\u226518 to \u226480 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.<\/p>\n \nThe primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).<\/p>\n \nFor more information about the frontMIND trial, please visit https:\/\/www.clinicaltrials.gov\/study\/NCT04824092<\/a>.<\/p>\n About Tafasitamab (Monjuvi\u00ae<\/sup>\/Minjuvi\u00ae<\/sup>) \nIn the U.S., Monjuvi\u00ae<\/sup> (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, 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 \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 \nIn Europe, Minjuvi\u00ae<\/sup> (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. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.<\/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 IMPORTANT SAFETY INFORMATION<\/b><\/p>\n What are the possible side effects of MONJUVI? \nThe most common side effects of MONJUVI include:<\/p>\n \nThese are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.<\/p>\n \nCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<\/p>\n Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:<\/b><\/p>\n \nYou should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.<\/p>\n Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.<\/b><\/p>\n Please see the full <\/b>Prescribing Information<\/b><\/a> for Monjuvi,<\/b> including Patient Information, for additional Important Safety Information.<\/p>\n About Incyte\u00ae \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 \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 \n\u00a0<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260613831839\/en\/<\/a><\/span><\/p>\n Media KEYWORDS:<\/b> Delaware Europe United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Oncology FDA Health Clinical Trials Pharmaceutical Biotechnology<\/p>\n
\nIncyte (Nasdaq:INCY) today announced positive results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi\u00ae<\/sup>\/Minjuvi\u00ae<\/sup>), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) versus R-CHOP, the current standard of care, as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Eligible patients had an International Prognostic Index (IPI) score of 3-5, or, for patients \u226460 years of age, an age-adjusted IPI (aaIPI) of 2-3.<\/p>\n\n
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<\/b>Tafa-Len-R-CHOP was generally well tolerated, and safety was consistent with the expected safety profile of adding Tafa-Len to R-CHOP. Safety findings included:<\/p>\n\n
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<\/b>Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1<\/sup> It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2<\/sup> Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe are diagnosed with DLBCL.3,4<\/sup> With about 40% of these patients not responding to initial therapy or relapsing thereafter5,6<\/sup>, there is a high medical need for new, effective therapies, particularly for high-risk patients.<\/p>\n
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<\/b>The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).<\/p>\n
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<\/b>Tafasitamab (Monjuvi\u00ae<\/sup>\/Minjuvi\u00ae<\/sup>) 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
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<\/b>MONJUVI may cause serious side effects, including:<\/b><\/p>\n\n
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<\/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
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<\/b>This 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 whether and when tafasitamab may provide a successful treatment option for patients with DLBCL and HGBL, the potential and promise suggested by the Phase 3 frontMIND results, the potential for Tafa-Len-R-CHOP to become a new standard of care option in the first-line treatment of DLBCL, Incyte\u2019s plans to advance its global regulatory filings for tafasitamab and Incyte\u2019s aspirations and goals as set forth under the heading \u201cAbout Incyte\u201d.<\/p>\n\n
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<\/b>media@incyte.com
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ir@incyte.com<\/a><\/p>\n
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