Treatment of refractory or relapsed (R/R) diffuse large B-cell lymphoma (DLBCL) has seen major advances in recent years, with the arrival of next-generation chimeric antigen receptor T-cell (CAR-T) therapies, bispecific T-cell engagers, and antibody-drug conjugates. This contrasts with the first-line setting, where Roche/Biogen’s Rituxan (rituximab) plus chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) dominates as the standard of care. Currently, up to 40% of approximately 165,000–220,000 newly diagnosed patients worldwide experience R/R disease, underscoring the need for more effective treatments for newly diagnosed patients.
At the American Society for Clinical Oncology (ASCO) Annual Meeting, held on May 29–June 2, 2026, Incyte announced results from its registrational Phase III trial, frontMIND (NCT04824092), evaluating their CD19 monoclonal antibody tafasitamab (marketed as Monjuvi in the US and Minjuvi globally) in newly diagnosed, untreated DLBCL patients. Monjuvi/Minjuvi was given in combination with lenalidomide and R-CHOP (“Tafa-Len-R-CHOP”; n=448), and compared to R-CHOP alone (n=451). Included patients were aged >60 years with an International Prognostic Index (IPI) score of 3–5, or patients ≤60 years with an age-adjusted IPI score of 2–3. After a median follow up of 35.2 months, the Tafa-Len-R-CHOP combination demonstrated a statistically significant improvement in progression free survival (PFS) against R-CHOP by 71.1% vs 62.9% (HR 0.75 [95% CI: 0.59, 0.96]; p=0.019), with a two-year PFS improvement of 8.2% against R-CHOP (71.1% vs 62.9%). Interestingly, this increase appeared consistent across both germinal centre B-cell (GCB) and activated B-cell (ABC) molecular subtypes of DLBCL (HR 0.59 [95% CI: 0.36, 0.95] and 0.69 [0.40,1.19] respectively). By the end of trial date, CR rate and overall response rate (ORR) were similar (65.2% vs 65.2% and 80.4% vs 76.1%, respectively), and final statistics are subject to follow-up analysis. While efficacy data is encouraging, Tafa-Len-R-CHOP patients did encounter a higher incidence of treatment emergent adverse events (TEAEs) grade 3 or higher (86.7% vs 76.1%), most commonly from cytopenias (serious febrile neutropenia was experienced in 13.3% Tafa-Len-R-CHOP patients vs 9.8% R-CHOP) with more TEAE dependent discontinuation (25.7% vs 17.9%), and TEAE related deaths (5.9% vs 3.8%). Side effects were generally considered clinically manageable, and deemed outweighed by the promising efficacy results.
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Currently, Roche’s Polivy (polatuzumab vedotin) is the only marketed agent in the front-line setting Incyte would only be competing against, which is used in the R-CHP combination (“Pola-R-CHP”) after the landmark POLARIX trial (NCT03274492), and in 2023, earned FDA approval for use in first-line patients. This demonstrated a 6.5% improvement in two-year PFS over R-CHOP alone, with no significant increase in adverse events. Importantly, while widely used, Pola-R-CHP does not provide any clinically meaningful improvement over R-CHOP in GCB DLBCL patients, which constitute 50–60% of DLBCL patients. This contrasts to the positive data from the Tafa-Len-R-CHOP GCB cohorts. More data is required to validate these results; molecular subtyping was only available for 57 patients in the Tafa-Len-R-CHOP group, however, if consistent, it could signal an opportunity for Monjuvi to be established as the standard of care option for this large patient group. It will be up to clinicians to determine whether these benefits are sufficient to outweigh the elevated toxicity profile of Tafa-Len-R-CHOP, as well as its more intensive, weekly treatment regimen required for Monjuvi administration, against the tri-weekly regimens of Pola-R-CHP and R-CHOP, particularly when treating more vulnerable patient groups.
In light of the presented findings, Incyte is moving forward with submission of a supplemental Biologics License Application (sBLA) for use of Monjuvi in combination with lenalidomide and R-CHOP in newly diagnosed patients. Should the sBLA be approved, GlobalData forecasts Monjuvi to grow at a CAGR of 54.3% from 2025 to 2032, approaching $2 billion in global annual sales by 2032.
