FDA Approves Tafasitamab Combo for R/R Follicular Lymphoma

Tafasitamab is not approved for use in with relapsed or refractory marginal zone lymphoma.

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

The efficacy of the regimen was assessed in the double-blind, placebo-controlled, international phase 3 inMIND trial (NCT04680052), in which 548 patients were randomly assigned 1:1 to either tafasitamab or placebo with lenalidomide and rituximab following at least 1 prior line of systemic therapy.^1,2

Efficacy was measured by progression-free survival (PFS), as assessed by the researchers. With a 14.1-month median follow-up, tafasitamab reduced the risk of death or disease progression by 57% (hazard ratio [HR], 0.43; 95% CI, 0.32-0.58; P < .0001).

Median PFS was estimated to be 22.4 months (95% CI, 19.2-not evaluable [NE]) for patients on the tafasitamab regimen vs 13.9 months (95% CI, 11.5-16.4) for patients on the control arm.

Out of patients enrolled in the trial, 25% had received 2 prior lines of therapy and 20% had received 3. The median prior lines of therapy was 1.

Tafasitamab is recommended by the FDA at an intravenous dose of 12 mg/kg for a maximum of 12 cycles, along with lenalidomide and rituximab.

Breaking Down Prior Data from inMIND

At the 2024 ASH Annual Meeting & Exposition, data from the inMIND trial was presented and the most common treatment-emergent adverse effects (TEAEs) of any grade in the tafasitamab and placebo arms, respectively, included neutropenia (48.5%; 45.2%), diarrhea (37.6%; 28.3%), COVID-19 (31.4%; 23.5%), constipation (29.2%; 24.6%), rash (21.9%; 21.3%), and fatigue (21.2%; 15.8%).³

Additionally, the most common grade 3 or 4 TEAEs in the tafasitamab and placebo arms, respectively, included neutropenia (39.8%; 37.5%), pneumonia (8.4%; 5.1%), thrombocytopenia (6.2%; 7.4%), and decreased neutrophil count (5.8%; 6.6%), among others.

“The inMIND phase 3 study met its primary end point of prolonging PFS in relapsed/refractory follicular lymphoma,” Laurie H. Sehn, MD, MPH, lead study author of BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, in Vancouver, Canada, said in a presentation of the data. “Benefit was observed in all prespecified subgroups, including patients with POD24 [progression of disease within 24 months of initial diagnosis], [those who were] refractory to prior anti-CD20 monoclonal antibodies, and [those] receiving multiple prior lines of therapy.”

The label for tafasitamab includes warnings for infusion-related reactions, myelosuppression, and infections.¹

Tafasitamab is not recommended for patients with relapsed or refractory marginal zone lymphoma (MZL)—which is also being investigated on the inMIND trial—who are not enrolled in controlled clinical trials for that treatment.^1,2

Patients eligible to enroll on inMIND must have a histologically confirmed grade 1, 2, or 3a diagnosis or follicular lymphoma or nodal MZL, splenic MZL, or extranodal MZL and have had at least 2 line of prior anti-CD20 immunotherapy or chemoimmunotherapy.² All patients had relapsed, refractory, or progressed disease after previous therapy and had an ECOG status of 0-2.

Reference

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. 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. December 12, 2022. Updated April 4, 2025. Accessed June 18, 2025. https://clinicaltrials.gov/study/NCT04680052?id=NCT04680052&rank=1#study-record-dates
3. Sehn LH, Luminari S, Scholz CW, et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Blood. 2024;144(suppl 2):LBA-1. doi:10.1182/blood-2024-212970