Adding Monjuvi and Revlimid to standard chemotherapy helped patients with newly diagnosed lymphoma live longer without disease worsening.
A phase 3 study found adding Monjuvi (tafasitamab) and Revlimid (lenalidomide) to standard R-CHOP chemotherapy improved progression-free survival for adults with newly diagnosed diffuse large B-cell lymphoma, supporting plans to seek regulatory approval to expand first-line treatment options for patients with higher-risk disease, according to a news release from Incyte.
The announcement reports positive topline results from the global frontMIND trial, which evaluated whether combining Monjuvi with Revlimid and R-CHOP could help patients with cancer live longer without their disease worsening when used as an initial treatment. Based on these findings, the company plans to file a supplemental biologics license application in the first half of 2026.
Progression-free survival: time during and after treatment that a patient lives without cancer growing or spreading.
Supplemental biologics license application: request to the FDA to approve a change to an already approved biologic such as a new use or patient population.
The frontMIND trial met its primary endpoint of progression-free survival as assessed by investigators using the Lugano 2014 criteria. Patients who received Monjuvi and Revlimid in addition to R-CHOP had a reduced risk of disease progression or death compared with those who received R-CHOP alone.
Specifically, the hazard ratio for progression-free survival was 0.75. This reflects a statistically significant improvement in progression-free survival for patients treated with the combination regimen.
The study also met a key secondary endpoint of event-free survival by investigator assessment. According to the company, no new safety signals were observed during the trial.
“The frontMIND results highlight the potential benefit of combining [Monjuvi] and [Revlimid] with R-CHOP as an effective treatment option, offering the possibility of cures for more newly diagnosed diffuse large B-cell lymphoma patients,” Dr. Steven Stein, chief medical officer of Incyte, said in the news release.
Incyte stated that the results support the potential benefit of adding Monjuvi and Revlimid to standard therapy for patients with cancer whose outcomes with existing first-line treatments have remained suboptimal.
The frontMIND trial is a randomized, double-blind, placebo-controlled, global phase 3 study in patients with previously untreated diffuse large B-cell lymphoma.
The study enrolled approximately 900 adults between 18 and 80 years of age. Participants were randomly assigned to receive Monjuvi and Revlimid in addition to R-CHOP or R-CHOP alone. R-CHOP consists of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone.
The primary endpoint of the study was investigator-assessed progression-free survival using the Lugano 2014 criteria. Key secondary endpoints included event-free survival and overall survival by investigator assessment.
Incyte reported that the frontMIND data will be submitted for presentation at an upcoming scientific meeting. Based on the positive topline results, the company expects to file a supplemental Biologics License Application for Monjuvi in the first half of 2026.
According to the press release, no new safety signals were observed in the frontMIND trial. However, Monjuvi is associated with known risks based on prior studies and approved indications.
Possible serious side effects include infusion reactions, low blood cell counts and infections. Infusion reactions may include fever, chills, flushing, headache or shortness of breath during treatment. Low blood cell counts involving platelets, red blood cells and white blood cells are common and can be serious or severe, increasing the risk of infection, bruising or bleeding.
Serious infections, including infections that can cause death, have occurred during treatment and after the last dose in some patients. Patients are advised to contact their health care provider if they develop a fever of 100.4° Fahrenheit or higher or signs of infection.
Common side effects reported with Monjuvi include feeling tired or weak, diarrhea, cough, fever, swelling of the lower legs or hands, respiratory tract infection and decreased appetite.
Patients should tell their health care provider about all medical conditions and medications before starting treatment. Monjuvi may harm an unborn baby, and patients who can become pregnant should use effective contraception during treatment and for at least three months after the final dose. Breastfeeding is not recommended during treatment and for at least three months afterward.
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