WILMINGTON, DE — Incyte (Nasdaq: INCY) on Thursday unveiled breakthrough results from a pivotal late-stage cancer trial that could redefine first-line treatment for one of the most aggressive forms of blood cancer, delivering new hope to tens of thousands of patients diagnosed each year.
The biotechnology company said its Phase 3 frontMIND trial met its primary goal, showing that the combination of tafasitamab, marketed as Monjuvi in the United States and Minjuvi in Europe, plus lenalidomide and standard R-CHOP chemotherapy significantly improved progression-free survival for newly diagnosed patients with diffuse large B-cell lymphoma, or DLBCL.
The study demonstrated a 25 percent reduction in the risk of disease progression or death compared with standard R-CHOP alone, based on investigator assessments using the Lugano 2014 criteria. The hazard ratio was 0.75, with a statistically significant p-value of 0.019. The trial also achieved its key secondary endpoint of event-free survival, with no new safety signals observed.
“This study highlights the potential benefit of combining tafasitamab and lenalidomide with R-CHOP as an effective treatment option, offering the possibility of cures for more newly diagnosed DLBCL patients,” said Dr. Steven Stein, Incyte’s chief medical officer. “Despite improvement in treatment for patients with DLBCL, outcomes for many high-risk patients are not optimal.”
Based on the positive results, Incyte said it plans to file a supplemental Biologics License Application with U.S. regulators in the first half of 2026 seeking approval to use the drug combination as a first-line therapy for adults with newly diagnosed DLBCL. The data will also be submitted for presentation at an upcoming scientific meeting.
DLBCL is the most common form of non-Hodgkin lymphoma in adults, accounting for about 40 percent of all cases worldwide. It is a fast-growing and aggressive cancer that can arise in lymph nodes or in organs such as the gastrointestinal tract, skin, or brain. About 24,000 people in the United States and as many as 36,000 in Europe are diagnosed each year, and roughly 40 percent of patients either fail initial treatment or relapse.
Tafasitamab is already approved in the United States and Europe for certain patients with relapsed or refractory DLBCL who are not eligible for stem cell transplant, as well as for follicular lymphoma. The new data could allow the drug to move into earlier treatment, where the potential impact is far greater.
The frontMIND trial enrolled about 900 adults across the globe, comparing tafasitamab and lenalidomide plus R-CHOP against R-CHOP alone in previously untreated patients. Its primary endpoint was progression-free survival, with overall survival and event-free survival tracked as key secondary measures.
More information about the frontMIND trial is available at https://www.clinicaltrials.gov/study/NCT04824092.
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