Incyte Highlights New Phase 3 Tafasitamab Data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
21.4.2026 16:00:00 CEST | Business Wire | Press release
- 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260421480376/en/
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
Fasset Hits $1B Valuation as SBI Group Leads $68M Series C to Scale AI-Powered Stablecoin Neobanking24.8.2026 08:03:00 CEST | Press release
Round led by SBI Group follows $51 million Series B raise in May 2026, marking ascent as one of the fastest-growing neobanking platforms. Capital will expand Own Network and deepen AI across stablecoin settlement, tokenization, and corridor banking. Fasset now processes more than $40 billion in annualized transaction volume, serving 3 million+ wallets and more than 1,000 enterprises across 125 countries. Fasset, the AI-powered stablecoin neobanking platform, today announced it has raised $68 million in Series C funding at a $1 billion valuation. The financing was led by SBI Group and follows Fasset’s $51 million Series B earlier this year, which brought Speedinvest onto the cap table alongside a group of strategic investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260823503947/en/ Mohammad Raafi Hossain, Co-Founder and CEO, Fasset The new capital will support the expansion of Own Network, Fasset’s regulated financial
Zanders Expands DACH Region with New Office in Vienna, Austria24.8.2026 07:11:00 CEST | Press release
Zanders, the global treasury, risk, and technology consultancy, today announced a significant expansion of its DACH region with the opening of a new office in Vienna. The move builds on Zanders' continued growth across Germany, Austria, and Switzerland, and marks another step in the firm's strategy of deepening its presence in the markets where client demand for specialized treasury, risk, and corporate finance advisory is growing fastest. DACH has been one of Zanders' priority regions for several years, with the firm steadily expanding its team and client base across Germany and Switzerland. Austria represents a natural next step in that growth: in conversations with clients in the market, Zanders has seen growing interest in treasury transformation and financing support, as companies work through interest rate volatility, refinancing needs, and a broader shift toward more digitized, centralized treasury operations. The new Vienna office allows Zanders to be closer to clients' operati
Novotech Strengthens Presence in Japan with Opening of Tokyo Office24.8.2026 01:01:00 CEST | Press release
Novotech, a leading global biotech CRO and full-service clinical research organization, has strengthened its established presence in Japan with the opening of a new office in Tokyo. The investment builds on Novotech’s existing operations and clinical trial activity in Japan and further enhances its ability to support Japanese biopharma companies as they advance programs regionally and across key international markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260823592174/en/ Takeshi Mori, Novotech Country Head, Japan The Tokyo office will serve as a strategic hub for Novotech’s growing operations in Japan, providing enhanced local expertise and strengthening collaboration with clients, partners, research institutions, and innovation ecosystems across the region. Novotech is currently supporting ongoing studies in Japan and provides sponsors with integrated support across early-phase clinical development in Australia, F
FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review21.8.2026 21:11:00 CEST | Press release
Authorizations add selection of ZYN ULTRA products to PMI U.S.’s growing portfolio of better alternatives for legal-age adults who smoke or use traditional oral tobacco products Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI’s U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review. Today’s action further enhances PMI’s leadership role in the smoke-free category. “We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” ZYN ULTRA positions the brand to furth
58% of Consumers Say They Don't Care Whether a Product is a National Brand or Private Label. They Just Buy What They Need21.8.2026 12:00:00 CEST | Press release
New NIQ & World Data Lab report reveals how consumer polarization is redefining value, accelerating private label adoption, and reshaping competition on the shelf As fast-moving consumer goods (FMCG) prices rose 26% globally between 2021 and 2025, consumers have become more deliberate about where they save and where they spend. NielsenIQ (NYSE: NIQ) has released new findings showing that private label is no longer viewed simply as a lower-cost substitute, but as a credible competitor across value, mainstream, and premium segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819950224/en/ Private label is no longer just a value play. The findings, published in NIQ’s latest report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, created in collaboration with World Data Lab, show how consumer polarization is redefining value and reshaping competition on the shelf. The report also draws on ins
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom