Incyte has reported positive top line data from the pivotal Phase III frontMIND trial assessing the safety and efficacy of tafasitamab (Monjuvi/Minjuvi) and lenalidomide added to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
DLBCL is the most common form of non-Hodgkin lymphoma (NHL) in adults, representing 40% of cases globally.
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The study compared this regimen against R-CHOP alone for patients with an International Prognostic Index (IPI) score of three to five for patients older than 60 years, or an age-adjusted IPI of two to three for those who are 60 years or younger.
The placebo-controlled, randomised, global, double-blind frontMIND trial enrolled around 900 adults aged 18 to 80 years.
Its primary endpoint was progression-free survival (PFS) as determined by investigator assessment using Lugano 2014 criteria.
The trial achieved its primary endpoint, with a hazard ratio of 0.75 and a p-value of 0.019. The key secondary endpoint of event-free survival (EFS) was also met. No new safety signals were reported during the study.
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By GlobalDataFollowing these findings, Incyte intends to submit a supplemental biologics licence application (sBLA) for tafasitamab as a first-line therapy for adults newly diagnosed with DLBCL during the first half of 2026. The company also plans to present the frontMIND study data at an upcoming scientific conference.
Incyte chief medical officer Steven Stein said: “The frontMIND study results highlight the potential benefit of combining tafasitamab and lenalidomide with R-CHOP as an effective treatment option, offering the possibility of cures for more newly diagnosed DLBCL patients.
“Despite improvement in treatment for patients with DLBCL, outcomes for many high-risk patients are not optimal. We look forward to working with regulatory authorities globally and to providing a new treatment option for patients in the future.”
Tafasitamab is currently approved in combination with lenalidomide by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed or refractory DLBCL.
It is also approved in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma.
In October 2025, Incyte announced results from the Phase IIIb TRuE-AD4 trial of Opzelura (ruxolitinib cream) in adults with moderate atopic dermatitis who had contraindications, inadequate response, or intolerance to topical corticosteroids and calcineurin inhibitors.
