WILMINGTON, DE — Incyte (Nasdaq: INCY) reported Phase III 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 and high-grade B-cell lymphoma, potentially positioning the combination as a new frontline treatment option.
The findings from the frontMIND study were presented during a plenary session at the European Hematology Association Congress in Stockholm and published in The Lancet. The results are expected to support regulatory submissions seeking approval of the combination therapy in newly diagnosed patients.
The trial evaluated tafasitamab, marketed as Monjuvi in the United States and Minjuvi in certain international markets, alongside lenalidomide and R-CHOP versus R-CHOP alone in adults with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL).
At a median follow-up of 35.2 months, patients receiving the tafasitamab-based regimen experienced a 25% reduction in the risk of disease progression or death compared with those receiving standard therapy alone, according to the study.
Progression-free survival rates were 71.1% at two years and 67.3% at three years for patients receiving the combination therapy, compared with 62.9% and 60.7%, respectively, for patients treated with R-CHOP alone.
The study also met a key secondary endpoint, showing a statistically significant improvement in event-free survival. Interim overall survival data favored the tafasitamab combination, although the difference had not yet reached statistical significance.
“A key goal in frontline treatment is to potentially prevent relapse and spare patients from requiring additional therapies later,” said Dr. Georg Lenz of University Hospital Münster and principal investigator of the frontMIND study. “The frontMIND results are especially encouraging because the addition of tafasitamab and lenalidomide improved outcomes without compromising delivery of the R-CHOP backbone.”
Incyte reported that positive progression-free survival trends were observed across predefined patient subgroups, including both major molecular subtypes of diffuse large B-cell lymphoma.
The study also found higher minimal residual disease negativity rates among patients receiving the tafasitamab combination, with 81.3% testing negative for residual disease compared with 66.7% in the control group.
Steven Stein, Incyte’s executive vice president and chief medical officer, said the results could help address a longstanding need in a patient population whose treatment outcomes have changed little over recent decades.
Diffuse large B-cell lymphoma is the most common form of non-Hodgkin lymphoma. Patients with high-risk disease face increased chances of relapse and poorer long-term outcomes despite advances in treatment.
The safety profile of the tafasitamab-based regimen was consistent with previously reported data, according to the company.
Incyte said the frontMIND results support ongoing global regulatory applications seeking approval of tafasitamab and lenalidomide in combination with R-CHOP as a first-line treatment for patients with previously untreated high-risk DLBCL and HGBL.
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