FDA Approves Tafasitamab Plus Lenalidomide and Rituximab for R/R Follicular Lymphoma

FDA

The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for adult patients with relapsed or refractory follicular lymphoma.1

The regulatory decision was supported by data from the phase 3 inMIND trial (NCT04680052), which demonstrated that at a median follow-up of 14.1 months, patients treated with the tafasitamab-based combination (n = 273) achieved a median progression-free survival (PFS) of 22.4 months (95% CI, 19.2-not evaluable [NE]) vs 13.9 months (95% CI, 11.5-16.4) for those given placebo plus lenalidomide and rituximab (n = 275) per investigator assessment (HR, 0.43; 95% CI, 0.32-0.58; P < .0001).1,2

Per independent review committee assessment, the median PFS was not reached (NR; 95% CI, 19.3-NE) for the experimental arm vs 16.0 months (95% CI, 13.9-21.1) in the control arm (HR, 0.41; 95% CI, 0.29-0.56).2

“Follicular lymphoma is generally an indolent yet chronic cancer that frequently recurs after treatment, making long-term disease control a critical objective,” Christina Poh, MD, an assistant professor of medicine at the University of Washington and Fred Hutchinson Cancer Center, stated in a news release. “The FDA approval of [tafasitamb] 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.”

Regarding safety, serious adverse effects were reported in 33% of patients in the tafasitamab arm. The rate of serious infections in this group was 24%.1

The most common AEs reported with the tafasitamab-based regimen included respiratory tract infections, diarrhea, rash, fatigue, muscle and bone pain, constipation, and cough.2 The most common grade 3/4 laboratory abnormalities that occurred in at least 20% of patients comprised decreased neutrophil count and decreased lymphocyte count.

inMIND Background

The double-blind, placebo-controlled, randomized study enrolled patients at least 18 years of age with histologically confirmed grade 1, 2, or 3a follicular lymphoma, nodal marginal zone lymphoma (MZL), splenic MZL, or extranodal MZL.3 Patients were required to have received at least 1 prior systemic anti-CD20 agent or chemoimmunotherapy. Patients needed to have documented relapsed, refractory, or progressive disease following prior systemic therapy, and an ECOG performance status of 0 to 2 was also required.

The study excluded patients who had a prior non-hematologic malignancy; congestive heart failure; HCV positivity, chronic HBV infection, or a history of HIV infection; an active systemic infection; or central nervous system lymphoma involvement.

Patients were randomly assigned to receive tafasitamab or placebo for 12 cycles. All patients received rituximab for 5 cycles and lenalidomide for 12 cycles.

The study's primary end point was PFS in the follicular lymphoma population. Secondary end points for patients with follicular lymphoma included complete response (CR) rate, overall response rate (ORR), minimal residual disease (MRD)–negativity rate, duration of response (DOR), overall survival (OS), and safety.

Additional Safety Data

Findings from inMIND also demonstrated that other serious AEs reported in at least 2% of patients included renal insufficiency (3.3%), second primary malignancies (2.9%), and febrile neutropenia (2.6%).

Fatal AEs reactions occurred in 1.5% of patients, which were attributed to COVID-19, sepsis, and adenocarcinoma.

"Patients living with relapsed or refractory follicular lymphoma have been waiting for new options that improve PFS without [a] substantial increase in [AEs]. Based on the data from the inMIND trial of [tafasitamab], today’s approval brings to this patient population the first CD19- and CD20-targeted immunotherapy combination and a potential new treatment standard,” Hervé Hoppenot, chief executive officer of Incyte, added in a news release. “This second US approval for [tafasitamab] reinforces our commitment to advancing innovation for the lymphoma community.”

In July 2020, the FDA granted accelerated approval to tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.

Tafasitamab Dosing in Follicular Lymphoma

Tafasitamab is recommended at a dose of 12 mg/kg via intravenous infusion for a maximum of 12 cycles, in combination with lenalidomide and rituximab.

References

1. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed June 18, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
2. Incyte announces FDA approval of Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma. News release. Incyte. June 18, 2025. Accessed June 18, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-monjuvir-tafasitamab-cxix
3. A phase 3 study to assess efficacy and safety of tafasitamab plus lenalidomide and rituximab compared to placebo plus lenalidomide and rituximab in patients with relapsed/​refractory (R/​R) follicular lymphoma or marginal zone lymphoma (InMIND). ClinicalTrials.gov. Updated April 4, 2025. Accessed June 18, 2025. https://clinicaltrials.gov/study/NCT04680052
4. FDA approves Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). News release. MorphoSys AG. July 31, 2020. Accessed June 18, 2025. https://www.businesswire.com/news/home/20200731005497/en/FDA-Approves-Monjuvi-tafasitamab-cxix-in-Combination-With-Lenalidomide-for-the-Treatment-of-Adult-Patients-With-Relapsed-or-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL