Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
diffuse large b-cell lymphomamedical
A fast-growing form of blood cancer that starts in white blood cells within the lymphatic system and can spread quickly to other organs. Investors watch it because the need for effective treatments, the size of the patient population, and results from clinical trials or regulatory approvals can significantly affect pharmaceutical and biotech company revenues—think of it like a large, urgent market for new medicines where trial results or approvals can move stock prices.
dlbclmedical
Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of blood cancer that starts in B cells, the immune system’s antibody-producing cells, and often grows quickly in lymph nodes or other organs. For investors, DLBCL matters because its severity drives demand for effective diagnostics and treatments, influencing drug development, clinical trial activity, regulatory decisions, and potential healthcare costs—similar to how a fast-moving fire spurs urgent demand for better firefighting tools.
r-chopmedical
A common chemotherapy regimen combining rituximab with four drugs—cyclophosphamide, doxorubicin, vincristine and prednisone—used mainly to treat certain types of non-Hodgkin lymphoma. It matters to investors because R-CHOP is the standard treatment benchmark against which new cancer drugs and trials are measured; think of it as the market’s baseline product that any newcomer must outperform or replace to gain market share, regulatory approval, or pricing power.
lenalidomidemedical
An oral medication that helps the immune system and directly slows growth of certain blood cancers and bone marrow disorders, often used long-term after diagnosis. Think of it as a targeted tool doctors use to control disease where stopping or changing the tool—because of safety issues, generic competition, regulatory moves, or patent status—can significantly change sales and future profit expectations, so investors watch approvals, safety advisories, and market exclusivity closely.
oral presentationtechnical
A spoken report given to an audience that summarizes facts, results or plans—often delivered at conferences, meetings or investor events. Investors watch oral presentations because they can reveal new data, management plans or interpretations that affect a company’s prospects; like hearing a coach explain a game plan, the tone, detail and emphasis can change expectations and market reactions almost immediately.
american society of clinical oncologymedical
A professional organization of cancer doctors, researchers and care teams that publishes clinical guidelines and hosts major conferences where new treatment trial results are presented. Investors watch its announcements because its guidelines and conference findings often shape which drugs and technologies are accepted by doctors and hospitals—similar to a respected referee whose rulings can change the commercial prospects and perceived value of healthcare companies.
hematologic malignancies—lymphoma and chronic lymphocytic leukemiamedical
Hematologic malignancies are cancers of the blood and immune system; lymphoma is a group of cancers that start in lymph nodes or related tissues, and chronic lymphocytic leukemia (CLL) is a slow-growing cancer of a type of white blood cell. Investors care because these conditions often require long-term or repeated treatments, create steady demand for drugs and diagnostics, and are common targets for new therapies and regulatory approvals that can drive a company’s sales and valuation.
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- 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
WILMINGTON, Del.--(BUSINESS WIRE)--
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))
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.
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.
