A favorable top-line result of a phase 3 trial has emboldened Incyte to request the FDA to approve the firm’s Monjuvi as a first-line drug against diffuse large B-cell lymphoma (DLBCL).
Incyte said Monday that phase 3 frontMIND trial data suggested that a combination of Monjuvi and lenalidomide (Revlimid) on top of the conventional R-CHOP regimen reduced the risk of disease progression or mortality by 25 percent in patients with a new diagnosis of DLBCL. R-CHOP consists of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
The trial hence achieved its main objective of progression-free survival (PFS) by investigator assessment. It also achieved a major secondary endpoint, event-free survival (EFS), which also includes the beginning of new anti-lymphoma therapy as a negative event.
Incyte, in its press release dated Jan. 5, did not reveal the specific number of percent improvement but only said that the data on the front MIND will be presented at a later medical conference.
With the phase 3 results under their belt, Incyte announced that it was looking to apply for Monjuvi in the first-line treatment of DLBCL in the first half of 2026. The Monjuvi-lenalidomide combo has already been approved as a second-line therapy against DLBCL in the U.S. with an accelerated approval in 2020, and the most recent frontMIND data may serve as the confirmatory evidence to grant it a full approval.
Incyte chief medical officer Steven Stein, M.D., stated in a statement dated Jan. 5 that the Monjuvi-lenalidomide-R-CHOP combination has the potential to cure a greater number of newly diagnosed DLBCL patients.
But Incyte may also have a few problems with FDA-and in the business market, should its regimen be introduced.
To begin with, the 25 percent PFS result is not so impressive for an oncology study. The FDA had considered a 27% PFS gain as a modest improvement in the Roche Polivy-R-CHP combo versus R-CHOP in 2023.
The FDA, at the time, by the inquiry into the Polivy data, including the absence of an overall survival (OS) benefit, underwent an advisory committee session. The release issued by Incyte Jan. 5 also had no data on OS, another important secondary endpoint of the frontMIND trial.
The complete analysis will be unveiled at a later big medical conference, which will feature the presentation of the OS analysis, Incyte spokesperson to Fierce Pharma.
On the bright side for Incyte, although there were raised issues by the FDA, the advisory panel experts supported Polivy since they believed in the statistically significant improvement in PFS, the highly effective R-CHOP was used as a control, and there was no increased toxicity. In 2023, the Roche regimen was eventually approved by the FDA for the first-line treatment of DLBCL.
Incyte said without providing details that the Monjuvi regimen did not have any new safety signals identified by FrontMIND. Earlier, during the phase 1b First-Mind trial, researchers wrote about the toxicity level of the mixture of seven drugs Monjuvi and found it to be comparable to that of R-CHOP.
On the assumption that Monjuvi passes its FDA approval, William Blair analysts wrote in a Monday note that they are not confident of the ultimate market share of the drug due to the crowded front-line DLBCL market.
Other than Polivy, Roche is overlaying its CD20xCD3 T-cell engager Columvi over Polivy-R-CHP in the phase 3 Skyglo trial. In the Epcore DLBCL-2 multicenter trial, AbbVie and Genmab are combining the CD20xCD3 bispecific Epkinly with R-CHOP, and are projected to read out in the current year.
Nonetheless, the William Blair team said it could have a role to play, especially in smaller community practices or with physicians who may want to use tolerability and ease-of-delivery in patients who might not be responsive to Polivy- or Epkinly-based regimens.
According to their 27% PFS benefit, Polivy-R-CHP has obtained a 35% market share of the first-line DLBCL, according to the William Blair analysts. Polivy sales increased 40 per cent annually in the first three quarters of 2025, to 1.1 billion Swiss francs ($1.4 billion). Monjuvi, which was accepted in other markets as Minjuvi generated approximately $103 million in sales in the period, which is an improvement of 19% on the period 2024.
The most frequent form of non-Hodgkin lymphoma is the DLBCL, which accounts for 40% of all cases. Incyte statistics indicate that approximately 24,000 individuals in the U.S and 36,000 in Europe are diagnosed with DLBCL annually.
Monjuvi is a CD19 antibody created at MorphoSys but later sold to Novartis at approximately 2.9 billion in 2024. Incyte initially acquired a partial right to Monjuvi in a deal with MorphoSys worth 750 M upfront in 2020. The Delaware pharma acquired the complete stake in the med alongside Novartis in the MorphoSys acquisition.
Incyte to Request FDA Approval for Seven-Drug Monjuvi Regimen in Front-Line DLBCL
Incyte Corporation is preparing to seek FDA approval for a new seven-drug Monjuvi regimen as a potential first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL). This proposed approach combines Monjuvi (tafasitamab-cxix) with the established R-CHOP chemotherapy backbone (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) plus lenalidomide, aiming to improve outcomes over standard therapy alone.
