FDA Approval of Tafa R2 Makes History in R/R Follicular Lymphoma

The FDA recently granted approval to tafasitamab (tafa) combined with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). This regulatory action marks the first approval of a CD19- and CD20-targeted immunotherapy for this patient population.¹ 

“In a disease that can be highly variable and where most patients experience normal overall survival, it is great to have more well tolerated non-chemotherapy options that extend remissions. The added physical toxicity of tafa appears to be modest, noting the added time commitment for infusions may be considered by some to be significant,” Ajay Gopal, MD, director, Clinical Research Division, Fred Hutchinson Cancer Center, professor, Division of Hematology and Oncology, University of Washington School of Medicine told Blood Cancers Today.

Results from the pivotal, randomized, double-blind, placebo-controlled phase 3 inMIND trial support the FDA’s decision to grant priority review and then approve the biologics license application for tafa with R2. A 57% reduction in the risk of disease progression or death was demonstrated with tafa plus R2 over R2 alone, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS).

The results come from 548 patients with relapsed or refractory FL between the ages of 31 and 88 years (median age, 64 years) who had a median of 1 prior line of treatment (range, 1-10). Per investigator assessment, the median PFS with the addition of tafasitamab was 22.4 months versus 13.9 months without (hazard ratio [HR], 0.43; 95% CI, 0.32-0.58; P<0.0001).

“The addition of tafa was associated with about a 10% improvement in CR rate, an approximately 8.5-month improvement in PFS. The AE [adverse event] profile was similar between the two arms was mainly attributed to the lenalidomide though there were modestly higher rates of COVID in the tafa group,” said Dr. Gopal. “There was no difference in OS [overall survival] with this duration of follow-up. There did not appear to be any reported biological subgroup that benefited more or less from the addition of tafa. Most patients were treated outside North America.”

At the time of their 2024 report, Gopal and colleagues announced that tafa plus R2 would be a new standard of care for relapsed or refractory FL and could be safely administered in both community and tertiary centers.

The FDA-approved dose of tafa is 12 mg/kg, to be administered via IV infusion for up to 12 cycles in combination with R2.

“Tafa provides yet another option for patients who are best suited for or prefer an approach that does not include cytotoxic chemotherapy and are able to devote the time to the additional infusion visits. It also builds toward a ‘chemo-free’ strategy, a long-term goal for many in the field,” Gopal noted.