FDA OKs Tafasitamab Combo for Relapsed Follicular Lymphoma

The FDA has approved tafasitamab-cxix in combination with rituximab and lenalidomide for the treatment of relapsed or refractory follicular lymphoma (FL).¹

Tafasitamab-cxix, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, is developed by Incyte under the brand name Monjuvi.¹

The FDA based its approval on results from the randomized, double-blind, placebo-controlled phase 3 inMIND trial presented at the 66th American Society of Hematology Annual Meeting & Exposition. Researchers randomly assigned 548 adult patients 1:1 to receive tafasitamab, 12 mg/kg, or placebo on days 1, 8, 15, and 22 of cycles 1-3 and days 1 and 15 of cycles 4-12 with standard dosing of rituximab and lenalidomide for up to twelve 28-day cycles.²

With a median follow-up of 14.1 months, adding tafasitamab to rituximab and lenalidomide significantly lowered the risk of progression, relapse, or death compared with placebo. The median investigator-assessed progression-free survival (PFS) was 22.4 months with the tafasitamab combination versus 13.9 months with placebo (95% CI, 0.43 [0.32, 0.58]; P<0.0001). Similarly, the median duration of response was longer with tafasitamab compared with placebo (21.2 months vs 13.6 months, respectively; 95% CI, 0.47 [0.33, 0.68]; P<0.0001). There was also a favorable trend for tafasitamab in terms of overall survival.²

As for safety, 99% of patients in both groups experienced treatment-emergent adverse events (AEs). Grade 3 or 4 AEs occurred in 71% of patients in the tafasitamab group and 69.5% in the placebo group, most commonly neutropenia, pneumonia, thrombocytopenia, decreased neutrophils, COVID-19, and COVID-19 pneumonia.²

“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, study investigator and Assistant Professor of Medicine at the University of Washington and Fred Hutchinson Cancer Center, in a press release.¹ “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.”