Frontline Tafasitamab Combo Improves PFS in Newly Diagnosed DLBCL

First-line treatment with tafasitamab (Monjuvi) plus lenalidomide (Revlimid) and rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) prolonged progression-free survival (PFS) vs R-CHOP alone among patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL), according to a press release on findings from the phase 3 frontMIND trial (NCT04824092) from the developer, Incyte.¹

Based on Lugano 2014 criteria, the addition of tafasitamab and lenalidomide to R-CHOP improved PFS per investigator evaluation (HR, 0.75; 95% CI, 0.59-0.96; P = .019). Additionally, the experimental combination met the secondary end point of event-free survival (EFS) based on investigator assessment. Data revealed no new safety signals.

Developers plan to file a supplemental biologics license application seeking approval for frontline tafasitamab among adults with newly diagnosed DLBCL in the first half of 2026. Additionally, investigators look to submit these trial findings for presentation at a future scientific meeting.

“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 [patients with] newly diagnosed DLBCL,” Steven Stein, MD, chief medical officer at Incyte, the developer of tafasitamab, stated in the press release.¹ “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.”

The double-blind, international phase 3 frontMIND trial included approximately 900 adults with newly diagnosed DLBCL with an International Prognostic Index (IPI) score of 3 to 5 who were older than 60 years or those no older than 60 years with an age-adjusted IPI score of 2 to 3. Patients were assigned to receive tafasitamab at 12 mg/kg on days 1, 8, and 15 for six 21-day cycles plus lenalidomide at 25 mg orally on days 1 to 10 of each cycle or matched placebo in combination with R-CHOP.² Additionally, R-CHOP consisted of rituximab at 375 mg/m² intravenously on day 1 of each cycle, cyclophosphamide at 750 mg/m² on day 1, doxorubicin at 50 mg/m² on day 1, vincristine at 1.4 mg/m² on day 1, and prednisone at 100 mg on days 1 to 5.

The trial’s primary end point was investigator-assessed PFS using Lugano Response Criteria for Malignant Lymphoma. Secondary end points included investigator-assessed EFS, overall survival, overall response rate, duration of complete response, and time to next antilymphoma therapy.

Patients aged 18 to 80 years old with previously untreated CD20-positive DLBCL, including but not limited to DLBCL not otherwise specified, including germinal center B-cell–like disease, T-cell–rich large BCL, ALK-positive large BCL, or grade 3b follicular lymphoma, were eligible for enrollment in the study. Other eligibility criteria included having archived or freshly available tumor tissue sent for retrospective central pathology review, an ECOG performance status of 0 to 2, a left ventricular ejection fraction of at least 50% per local echocardiography or cardiac multigated acquisition testing, and adequate hematologic function.

Those with a history of prior nonhematologic malignancies, any systemic antilymphoma and/or investigational treatments prior to beginning study therapy, known central nervous system involvement, or contraindications to any component of R-CHOP were ineligible for enrollment in the trial. Patients with known active bacterial, viral, fungal, or other types of infections at screening, including those with suspected active or latent tuberculosis, were also ineligible for study entry.

References

1. Incyte announces positive topline results from pivotal study of tafasitamab (Monjuvi/Minjuvi) as a first-line treatment for diffuse large B-cell lymphoma. News release. Incyte. January 5, 2026. Accessed January 5, 2026. https://tinyurl.com/5n22b84p
2. Tafasitamab + lenalidomide + R-CHOP versus R-CHOP in newly diagnosed high-intermediate and high risk DLBCL patients (frontMIND). ClinicalTrials.gov. Updated September 8, 2025. Accessed January 5, 2026. https://tinyurl.com/3mracd2y