The FDA has approved Incyte’s CD19-targeting monoclonal antibody Monjuvi (tafasitamab-cxix) for use in combination with rituximab and lenalidomide in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval, which received FDA Priority Review designation, is based on results from the Phase III inMIND trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to rituximab and lenalidomide alone.¹

How Did the inMIND Trial Support FDA Approval of Monjuvi for Follicular Lymphoma?

"Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without substantial increase in side effects,” said Hervé Hoppenot, CEO, Incyte, in a press release. “Based on the data from the inMIND trial of Monjuvi, today’s approval brings to this patient population the first CD-19 and CD20-targeted immunotherapy combination and a potential new treatment standard. This second US approval for Monjuvi reinforces our commitment to advancing innovation for the lymphoma community.”

Key nMINDTrial Details and Efficacy Results

• The global, double-blind, randomized, controlled inMIND trial evaluated the efficacy and safety of Monjuvi in combination with rituximab and lenalidomide compared to placebo in combination with rituximab and lenalidomide in 654 adult patients with R/R FL grade 1 to 3a or R/R nodal, splenic or extranodal marginal zone lymphoma.
• The primary endpoint of the trial was PFS by investigator assessment in the FL population.
• Secondary endpoints included PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.
• Patients receiving the Monjuvi combination achieved a median PFS of 22.4 months compared to 13.9 months in the control arm (HR: 0.43; P<0.0001), with a 57% reduction in the risk of death or disease progression.
• Additionally, 27.5% of patients in the Monjuvi combination arm experienced disease progression or death compared to 47.6% of patients in the control arm.
• At the time of data readout, median PFS was not reached in the Monjuvi arm, while median PFS was 16 months in the control arm.

Safety Profile

• Serious adverse events (SAEs) occurred in 33% of patients in the Monjuvi arm.
• Twenty-four percent experienced serious infections, such as COVID-19 or pneumonia. Other SAEs included renal insufficiency, second primary malignancies, and febrile neutropenia.
• Fatal adverse events (AEs) were reported in 1.5% of patients and included COVID-19, sepsis, and adenocarcinoma.
• The most common AEs included respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.¹

“Follicular lymphoma is generally an indolent yet chronic cancer that frequently recurs after treatment, making long-term disease control a critical objective,” said Christina Poh, MD, assistant professor of medicine, University of Washington, Fred Hutchinson Cancer Center, in the press release. “The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease.”

Follicular Lymphoma Landscape

FL is the most common indolent form of non-Hodgkin lymphoma, with an estimated 15,000 new cases annually in the United States. The median age at diagnosis is 60 years. According to the Leukemia & Lymphoma Society, the five-year relative survival rate is approximately 87.7%, with younger patients generally experiencing more favorable outcomes.²

“While the initial responses to FL treatment are often positive, recurrence can become increasingly difficult for patients to manage as they navigate emotions and the next treatment steps related to relapse,” said Mitchell Smith, MD, PhD, chief medical officer, Follicular Lymphoma Foundation, in the press release. "We are pleased that the FDA has approved tafasitamab, part of a treatment combination offering a new option for patients living with this chronic disease.”

References

1.Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma. Incyte. June 18, 2025. Accessed June 20, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-monjuvir-tafasitamab-cxix

2. Follicular Lymphoma (FL). Leukemia & Lymphoma Society. Accessed June 20, 2025. https://www.lls.org/research/follicular-lymphoma-fl#:~:text=FL%20is%20the%20most%20common%20slow%2Dgrowing%20non%2DHodgkin's,having%20an%20average%20age%20of%20approximately%2060.