WILMINGTON, DE — Incyte reported Phase 3 trial results showing that adding tafasitamab and lenalidomide to the standard R-CHOP regimen reduced the risk of disease progression or death in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), supporting planned regulatory submissions for the combination therapy.
The results from the frontMIND trial were presented at the 2026 American Society of Clinical Oncology annual meeting and published simultaneously in The Lancet. The study evaluated tafasitamab, marketed as Monjuvi or Minjuvi, and lenalidomide in combination with R-CHOP, the current standard first-line treatment for these aggressive blood cancers.
According to the company, the combination therapy reduced the risk of disease progression or death by 25% compared with R-CHOP alone, meeting the study’s primary endpoint of progression-free survival. After a median follow-up of 35.2 months, progression-free survival rates were 71.1% at two years and 67.3% at three years for patients receiving the combination regimen, compared with 62.9% and 60.7%, respectively, for patients treated with R-CHOP alone.
The study also met a key secondary endpoint, demonstrating a statistically significant improvement in event-free survival. Interim overall survival data showed a positive trend favoring the combination therapy, although the difference was not statistically significant at the current stage of 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,” noted Dr. Georg Lenz of University Hospital Münster, 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.”
Incyte Chief Medical Officer Steven Stein characterized the findings as a potential turning point for newly diagnosed patients with high-risk disease. “These findings support Tafa-Len-R-CHOP as a potential new standard of care option in the first-line treatment of DLBCL,” he said.
The company reported that benefits were observed across prespecified patient subgroups, including both major molecular subtypes of diffuse large B-cell lymphoma.
Safety findings were generally consistent with the known profiles of the individual therapies. Grade 3 or higher treatment-emergent adverse events occurred in 86.7% of patients receiving the combination regimen, compared with 76.1% in the R-CHOP-only arm. Treatment discontinuation rates, however, were similar between the two groups.
Global regulatory filings are planned based on the frontMIND results, which could position the regimen as a new first-line treatment option for patients with previously untreated high-risk DLBCL.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.