Announcement • Jun 02

Incyte Announces Positive Results from Pivotal Phase 3 Frontmind Trial Evaluating Tafasitamab (Monjuvi/Minjuvi) and Lenalidomide Added to R-Chop Versus R-Chop Alone in Previously Untreated High-Risk Dlbcl and Hgbl

Incyte announced positive results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi/Minjuvi), 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 alone 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 =60 years of age, an age-adjusted IPI (aaIPI) of 2-3. The Phase 3 frontMIND study evaluated tafasitamab (Monjuvi/Minjuvi) and lenalidomide in addition to R-CHOP, the current standard of care, compared with R-CHOP alone in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL). Positive trends toward progression-free survival (PFS) benefit with tafasitamab and lenalidomide plus R-CHOP (Tafa-Len-R-CHOP) were observed across prespecified subgroups, including in patients with centrally confirmed lymphoma subtypes and both cell-of-origin (COO) molecular subtypes. The frontMIND data support the submission of global regulatory applications for tafasitamab and lenalidomide added to R-CHOP for previously untreated DLBCL. The data are being presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet. The results build on previously reported topline data indicating the trial met its primary endpoint of progression-free survival (PFS) by investigator assessment. The data demonstrate that Tafa-Len-R-CHOP resulted in a statistically significant and clinically meaningful improvement in PFS, with a 25% reduction in risk of disease progression or death among patients treated with Tafa-Len-R-CHOP compared with R-CHOP alone (HR 0.75 [P=0.0194]; 95% CI, 0.59–0.96; median follow-up of 35.2 months). A PFS increase of 8.2% was seen at 2 years (71.1% with Tafa-Len-R-CHOP vs 62.9% with R-CHOP). A PFS increase of 6.6% was seen at 3 years (67.3% with Tafa-Len-R-CHOP vs 60.7% with R-CHOP). Additionally, point estimates suggested trends toward PFS advantage with Tafa-Len-R-CHOP are broadly consistent across prespecified subgroups, including patients with centrally confirmed lymphoma subtypes and across COO molecular subtypes (ABC [Activated B-cell-like] and GCB [Germinal Center B-cell-like]). Treatment with Tafa-Len-R-CHOP also significantly improved the key secondary endpoint of event-free survival (EFS) compared to R-CHOP alone (HR 0.79 [P=0.0260] 95% CI, 0.64-0.97; median follow-up of 35.4 months). Additionally, interim overall survival (OS) analysis demonstrated a positive trend toward improvement (HR=0.85 [P=0.2703] 95% CI, 0.63–1.14, median follow-up of 35.9 months), with final analysis planned after additional follow-up. Tafa-Len-R-CHOP was generally well tolerated, and safety was consistent with the expected safety profile of adding Tafa-Len to R-CHOP. The most common treatment-emergent adverse events (TEAEs) in the Tafa-Len-R-CHOP group were neutropenia (70.7%), anemia (46.3%) and peripheral neuropathy (40.6%). Any grade TEAEs were similar in both treatment arms (98.6% vs 97.1%). More Grade =3 TEAEs occurred with Tafa-Len-R-CHOP (86.7%) vs R-CHOP alone (76.1%). The most common Grade 3 TEAEs in the Tafa-Len-R-CHOP group were anemia (22.8%), thrombocytopenia (13.1%) and neutropenia (12.4%). The most common Grade 3 TEAEs with R-CHOP alone were anemia (15.9%), febrile neutropenia (8.7%) and thrombocytopenia (6.7%). The incremental safety events observed with Tafa-Len-R-CHOP were well managed and did not interfere with the delivery of the R-CHOP backbone. Rates of TEAEs leading to discontinuation of all study treatment were similar between the two groups (5.2% for Tafa-Len-R-CHOP and 5.4% for R-CHOP alone). Although a higher rate of fatal TEAEs was observed with Tafa-Len-R-CHOP (5.9% vs 3.8% with R-CHOP), there were fewer overall deaths with Tafa-Len-R-CHOP (82 [18.5%]) compared to R-CHOP (97 [21.7%]), consistent with the positive trend observed in OS. The frontMIND data support the submission of global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL. 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). The study enrolled 899 adults (=18 to =80 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 alone. The 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). 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). 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). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency (EMA) 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).

CEO salary percentage	2.02%
CEO tenure	1.1yrs
CEO ownership	0.08%
Management average tenure	1.1yrs
Board average tenure	7.6yrs

Date	Total Compensation	Salary	Company Earnings
Mar 31 2026	n/a	n/a	US$1b
Dec 31 2025	US$32m	US$647k	US$1b

Name	Position	Tenure	Compensation	Ownership
William Meury	CEO & Director	1.1yrs	US$32.09m	0.078% € 15.6m
Pablo Cagnoni	President and Global Head of R&D	less than a year	US$8.84m	0.014% € 2.8m
Thomas Tray	Principal Financial Officer	4.3yrs	US$990.37k	0.0033% € 653.3k
Steven Stein	Executive VP	11.3yrs	US$6.30m	0.038% € 7.6m
Mohamed Issa	Executive Vice President & Head of U.S. Commercial	1.5yrs	US$10.59m	0% € 0
Suketu Upadhyay	Executive VP & CFO	less than a year	no data	no data
Michael Morrissey	Executive VP & Head of Global Technical Operations	10.5yrs	no data	0.0058% € 1.2m
Alexis Smith	VP & Head of Investor Relations	no data	no data	no data
Richard Hoffman	Executive VP	less than a year	no data	no data
Pamela Murphy	VP of Investor Relations & Corporate Communications	no data	no data	no data
Soni Basi	Executive VP & Chief Human Resources Officer	less than a year	no data	no data
James Lee	Group VP	no data	no data	no data

Name	Position	Tenure	Compensation	Ownership
William Meury	CEO & Director	1.1yrs	US$32.09m	0.078% € 15.6m
Jean-Jacques Bienaime	Independent Director	11.5yrs	US$536.14k	0.011% € 2.3m
Julian Baker	Independent Chairman of the Board	24.7yrs	US$573.14k	0.14% € 27.9m
Otis Brawley	Independent Director	4.8yrs	US$511.14k	0.0056% € 1.1m
Jacqualyn Fouse	Independent Director	8.7yrs	US$524.64k	0.0097% € 1.9m
Edmund Harrigan	Independent Director	6.6yrs	US$539.64k	0.011% € 2.1m
Katherine High	Independent Director	6.3yrs	US$511.14k	0.0067% € 1.3m
Paul Clancy	Independent Director	11.5yrs	US$538.14k	0.012% € 2.4m

Data	Last Updated (UTC time)
Company Analysis	2026/07/14 10:37
End of Day Share Price	2026/07/14 00:00
Earnings	2026/03/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Jasper Hellweg	Argus Research Company
Thomas Russo	Baird
Peter Lawson	Barclays

Incyte Management

Management criteria checks 1/4

Key information

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