Incyte Highlights New Phase 3 Tafasitamab Data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

- Data from pivotal frontMIND study of tafasitamab (Monjuvi®/Minjuvi®) in first-line diffuse large b-cell lymphoma (DLBCL) featured in oral presentation at ASCO; results support global regulatory submissions

Incyte (Nasdaq:INCY) today announced that full results from the Phase 3 pivotal study evaluating tafasitamab (Monjuvi^®/Minjuvi^®) in first-line diffuse large b-cell lymphoma (DLBCL) will be featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago.

“The positive Phase 3 frontMIND results for tafasitamab in patients with newly diagnosed diffuse large B-cell lymphoma highlight Incyte’s continued focus on advancing novel differentiated approaches with the potential to meaningfully impact patients,” said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. “We look forward to sharing the full data at ASCO, and to progressing our pipeline.”

Presentation details:

frontMIND: Phase 3 Study of tafasitamab (Tafa) Plus lenalidomide (Len) and R-CHOP for Patients (pts) with Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
(Abstract #7000. Session: Oral Abstract Session - Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia. May 30, 4:00 – 7:00 p.m. ET (3:00 – 6:00 p.m. CDT))

More information regarding the 2026 ASCO Annual Meeting can be found at: https://www.asco.org/annual-meeting.

About Tafasitamab (Monjuvi^®/Minjuvi^®)

Tafasitamab (Monjuvi^®/Minjuvi^®) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. 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). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi^® (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).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

In 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. 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.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb^® is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

About Incyte^®

Incyte is redefining what’s 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.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

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 Incyte’s clinical development pipeline, the potential and promise offered by tafasitamab, including its ability to provide a differentiated treatment option or meaningfully impact patients with newly diagnosed diffuse large B-cell lymphoma, among other conditions, and the overall strength of Incyte’s hematology and oncology portfolio contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including risks and uncertainties regarding research and development of 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, determinations made by the FDA, EMA and other regulatory authorities and the timing thereof, the efficacy or safety of Incyte’s products, the acceptance of Incyte’s products in the marketplace, market competition, sales, marketing, manufacturing and distribution requirements, and other risks detailed from time to time in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

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