Incyte (NASDAQ:INCY) today 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 oral presentation of these data is taking place at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2026, in Chicago (Abstract #LBA7000. 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]) with simultaneous publication in The Lancet*.

"The Phase 3 frontMIND results mark a potential inflection point in the treatment of patients with previously untreated, high-risk DLBCL and HGBL, where outcomes have remained largely unchanged for decades," said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development, Incyte. "These findings support Tafa-Len-R-CHOP as a potential new standard of care option in the first-line treatment of DLBCL, with benefit observed across both cell-of-origin (COO) molecular subtypes, and we look forward to advancing our global regulatory filings as we seek to bring this option to patients."

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.

"For years, R-CHOP has remained the standard first-line therapy for DLBCL, yet nearly 40% of patients experience disease progression or relapse after initial treatment, underscoring the need for innovation," said Dr. Georg Lenz, University Hospital Münster and principal investigator of the frontMIND study. "The frontMIND study shows that adding tafasitamab and lenalidomide to R-CHOP improved outcomes, including in patients with high-risk disease, who have historically faced poor prognoses and limited treatment options. These results suggest that this regimen could help broaden the first-line treatment options for this patient population."

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%).

Importantly, 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.