Clinical Summary: 

• Design/Population: The phase 3 frontMIND trial evaluated tafasitamab plus lenalidomide and R-CHOP in previously untreated patients with high-risk diffuse large B-cell lymphoma or high-grade B-cell lymphoma.
• Key Outcomes: Tafasitamab plus lenalidomide and R-CHOP significantly improved survival compared with R-CHOP alone, with benefit observed across molecular subtypes and key clinical subgroups. 
• Clinical Relevance: These findings suggest that adding tafasitamab and lenalidomide to R-CHOP may represent a new frontline treatment option for patients with high-risk DLBCL.

Results from the phase 3 frontMIND trial demonstrated that tafasitamab plus lenalidomide and R-CHOP significantly improved progression-free survival (PFS) outcomes compared with R-CHOP alone among previously untreated patients with high-risk diffuse large B-cell lymphoma or high-grade B-cell lymphoma. 

These findings were presented by George Lenz, MD, University Hospital Münster, Münster, Germany, at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden. 

In this double-blind, placebo-controlled trial, 899 patients were randomized 1:1 to receive either tafasitamab plus lenalidomide and R-CHOP (n = 448) or R-CHOP alone (n = 451). The primary end point was investigator-assessed PFS. Key secondary end points included event-free survival (EFS), overall survival (OS), PET-negative complete response, objective response rate (ORR), safety, and quality of life.

At a median follow-up of 35.2 months, tafasitamab plus lenalidomide and R-CHOP reduced the risk of disease progression or death by 25% compared with R-CHOP alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.59 to 0.96; P = .019). The 24-month PFS rate was 71.1% in the tafasitamab arm and 62.9% in the R-CHOP arm. 

Among patients centrally confirmed lymphoma subtypes (n = 773), the 24-month PFS rates were 72.7% and 62.2%, respectively. PFS benefit was observed across molecular subtypes, including activated B-cell-like disease (HR, 0.59) and germinal center B-cell-like disease (HR, 0.69).

The EFS rate was 34.4% in the tafasitamab arm and 42.4% in the R-CHOP arm (HR, 0.79; 95% CI, 0.64 to 0.97; P = .026), with OS rates of 18.3% and 21.1% (HR, 0.85; 95% CI, 0.63 to 1.14; P = .270), and ORRs of 80.4% and 76.1% (P = .120). The PET-negative complete response rate was 65.2% in the tafasitamab arm and 65.2% in the R-CHOP arm (P = 0.987). Quality-of-life outcomes improved in both treatment arms, with no significant differences observed between groups.

Any-grade treatment-emergent adverse events were reported in 98.6% of patients in the tafasitamab arm and 97.1% of patients in the R-CHOP arm. Grade ≥3 treatment-emergent adverse events were reported in 86.7% and 76.1% of patients, respectively. Treatment discontinuation rates were similar between treatment groups (5.2% vs 5.4%). Treatment-emergent adverse events led to death in 5.9% of patients in the tafasitamab arm and 3.8% of patients in the R-CHOP arm, although fewer deaths overall were reported in the experimental arm (18.5% vs 21.7%).

“[Tafisitamab plus lenalidomide and] R-CHOP represents a potential new [frontline] standard of care for patients with high-risk [diffuse large B-cell lymphoma or high-grade B-cell lymphoma], regardless of [cell-of-origin] molecular subtype,” concluded Dr Lenz. 

Source: 

Lenz G, Trneny M, Burke JM, et al. Tafisitamab Plus Lenalidomide and R-CHOP for patients with previously untreated diffuse large B-cell lymphoma (DLBCL): Results form the phase 3 FRONTMIND study. Presented at EHA Congress. June 11 - June 14, 2026. Stockholm, Sweden. Abstract EHA-2190.