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Incyte Study Shows Lymphoma Drug Combo Slows Aggressive Blood Cancer

Benzinga·01/05/2026 16:59:47
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Incyte Corporation (NASDAQ:INCY) on Monday shared topline results from the pivotal Phase 3 frontMIND trial of tafasitamab (Monjuvi/Minjuvi) combo as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

The trial evaluated tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) compared to R-CHOP alone.

The trial met its primary endpoint of progression-free survival (PFS). The trial also met its key secondary endpoint of event-free survival (EFS) by investigator assessment. No new safety signals were observed.

Also Read: Incyte’s New Therapy Shows Signs Of ‘Disease-Modifying’ Potential In Rare Blood Cancer

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases. It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin, and brain.

Incyte expects to file a supplemental Biologics License Application (sBLA) for tafasitamab for the first-line treatment of adults with newly diagnosed DLBCL in the first half of 2026.

Tafasitamab was approved in combination with lenalidomide by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 and 2021, respectively, for adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.

Additionally, tafasitamab was approved in combination with lenalidomide and rituximab by the FDA in June 2025 for adult patients with relapsed or refractory follicular lymphoma (FL).

Analyst Take

William Blair views the positive frontMIND results as supportive of a meaningful, but likely modest, indication expansion opportunity for Monjuvi in frontline DLBCL beyond its current use in relapsed or refractory DLBCL and follicular lymphoma.

Analyst Matt Phipps remains cautious on ultimate market share for Monjuvi given the crowded frontline DLBCL landscape, with several novel R-CHOP-based regimens in ongoing Phase 3 studies, most notably including AbbVie Inc. (NYSE:ABBV)/Genmab AS(NASDAQ:GMAB) Epkinly, where Phase 3 readout in frontline DLBCL is expected in 2026.

INCY Price Action: Incyte shares were up 0.59% at $102.01 at the time of publication on Monday, according to Benzinga Pro data.

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