Behind the FDA Approval: Dr Poh on Tafasitamab in FL

Christina Poh, MD, assistant professor, University of Washington, Fred Hutchinson Cancer Center, discusses the recent FDA approval of tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid) and rituximab (Rituxan) for relapsed/refractory follicular lymphoma (R/R FL).¹

She explains that follicular lymphoma, while generally indolent, is a chronic and relapsing disease, making durable disease control a central goal of treatment. This is especially challenging in high-risk subgroups, such as patients who relapse within 24 months of first-line therapy or those who are refractory to rituximab.

She highlights that this approval is important because the results from the phase 3 inMIND study (NCT04680052) showed a significant reduction in progression risk with the new chemo-free triplet regimen. What’s particularly noteworthy is that this benefit extended across a broad patient population, including high-risk subtypes that have traditionally been difficult to manage. The triplet demonstrated not only improved progression-free survival (PFS) but also a manageable safety profile, which further supports its use in a wider range of clinical scenarios.

Specifically, with a median follow-up of 14.1 months, the study demonstrated a statistically significant improvement in PFS for the tafasitamab arm vs the control arm. The hazard ratio for disease progression or death was 0.43 (95% CI, 0.32-0.58; P <.0001), representing a 57% reduction in risk. Median PFS was 22.4 months (95% CI, 19.2-not evaluable [NE]) in the tafasitamab group vs 13.9 months (95% CI, 11.5-16.4) in the control arm. Additionally, the median PFS was not yet reached (NR; 95% CI, 19.3-NE) with the triplet vs 16.0 months (95% CI, 13.9-21.1) with the doublet (HR, 0.41; 95% CI, 0.29-0.56; P <.0001).²

For safety, tafasitamab in this combination was consistent with known adverse events (AEs) from prior studies involving CD19-targeted therapies. Serious AEs occurred in 33% of patients receiving tafasitamab, with serious infections reported in 24%.¹

The approval of this dual-targeted immunotherapy (CD19 and CD20) marks a major advancement in FL treatment, offering an effective option without chemotherapy. According to Poh, this is more than a niche treatment—it represents a potential new standard for diverse patients with FL, not just those with favorable risk profiles. By expanding effective options for historically underserved subgroups, this regimen could help shift the treatment paradigm and offer more consistent disease control across the FL spectrum.

REFERENCES:

1. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. News release. US FDA. June 18, 2025. Accessed June 18, 2025. https://tinyurl.com/4a97zn26

2. 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