frontMIND Trial Reports PFS Benefit for Tafasitamab-Lenalidomide + R-CHOP in DLBCL

The phase 3 frontMIND trial evaluated tafasitamab (Monjuvi; Incyte) plus lenalidomide added to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), a regimen known as Tafa-Len-R-CHOP, versus R-CHOP alone in adults with previously untreated high-intermediate and high-risk diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma.

Incyte reported that the trial met its primary endpoint of investigator-assessed progression-free survival (PFS). With a median follow-up of 35.2 months, Tafa-Len-R-CHOP reduced the risk of disease progression or death by 25% compared with R-CHOP alone, with a hazard ratio of 0.75 and P=.0194. The 2-year PFS rate was 71.1% with Tafa-Len-R-CHOP versus 62.9% with R-CHOP; at 3 years, the rates were 67.3% versus 60.7%.

Treatment with Tafa-Len-R-CHOP also significantly improved the key secondary endpoint of event-free survival (EFS) compared with R-CHOP alone (HR, 0.79; 95% CI, 0.64-0.97; P=0.0260; median follow-up, 35.4 months). Additionally, interim overall survival (OS) analysis demonstrated a positive trend toward improvement (HR, 0.85; 95% CI, 0.63-1.14; P=0.2703; median follow-up, 35.9 months), with final analysis planned after additional follow-up.

According to the American Society of Clinical Oncology (ASCO), the results are notable because the population included in the trial had high-intermediate risk and high-risk disease, which typically leads to poor outcomes. The frontMIND data will be used to support regulatory submissions seeking approval for tafasitamab and lenalidomide in addition to R-CHOP for adults with newly diagnosed DLBCL and HGBL.

https://www.asco.org/about-asco/press-center/immunotherapies-r-chop-delays-progression-b-cell-lymphomas