Dr Mehta on the FDA Approval of Tafasitamab Plus Rituximab/Lenalidomide in R/R Follicular Lymphoma

"The FDA recently approved tafasitamab in combination with rituximab and lenalidomide for the treatment of relapsed or refractory follicular lymphoma, providing a strong therapeutic option for this patient population. If [we look] back 10 to 15 years ago, outcomes for patients [with relapsed/refractory follicular lymphoma] were very limited. However, with newer treatments such as bispecific antibodies and CAR T-cell therapy, treatment outcomes have significantly improved for patients with follicular lymphoma."

Amitkumar Mehta, MD, a hematologist-oncologist at the University of Alabama at Birmingham, discussed the clinical implications of the FDA approval of tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for the treatment of adult patients with relapsed or refractory follicular lymphoma, based on data from the phase 3 inMIND trial (NCT04680052).

On June 18, 2025, the FDA approved this triplet regimen after results from the study showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment for the tafasitamab regimen compared with placebo plus lenalidomide and rituximab (HR, 0.43; 95% CI, 0.32-0.58; P < .0001). The median PFS in the tafasitamab group was 22.4 months (95% CI, 19.2-not evaluable) vs 13.9 months (95% CI, 11.5–16.4) in the control arm.

Additionally, PFS outcomes per independent review committee (IRC) were consistent, with the median PFS not reached (95% CI, 19.3-NE) in the tafasitamab group vs 16.0 months (95% CI, 13.9-21.1) in the control arm (HR, 0.41; 95% CI, 0.29-0.56). Benefit was observed across prespecified subgroups, including number of prior lines of therapy.

According to Mehta, follicular lymphoma remains an indolent but incurable B-cell lymphoma characterized by a chronic relapsing course. Although survival has improved with modern immunotherapies, many patients experience multiple relapses over time. Thus, delaying disease progression and deferring the need for additional therapies are key treatment goals. The addition of tafasitamab, an anti-CD19 monoclonal antibody, to the established backbone of lenalidomide plus rituximab provides a novel dual-targeted approach that enhances disease control and maintains tolerability, he said.