Adding tafasitamab-cxix, an anti-CD19 monoclonal antibody, to lenalidomide and rituximab significantly prolonged progression-free survival in patients with relapsed or refractory follicular lymphoma, according to data presented at the European Hematology Association (EHA) 2025 Congress (Abstract S230).

Results from the phase III inMIND study demonstrated a significant reduction in the risk of disease progression, relapse, or death by 57% when tafasitamab was added to lenalidomide and rituximab compared with placebo. The median progression-free survival was substantially improved at 22.4 months for patients receiving tafasitamab vs 13.9 months in the placebo group (hazard ratio [HR] = 0.43; P < .0001).

Authors of the study emphasized that benefits were consistently observed across all key prespecified patient subgroups. Based on the data from the inMIND trial, the U.S. Food and Drug Administration approved this regimen on June 18.

“The addition of tafasitamab to lenalidomide and rituximab resulted in significant and clinically meaningful improvement,” said lead study author Marek Trněný, MD, CSc, Professor of Medical Oncology and Head of the First Faculty of Medicine at Charles University Hospital, Charles University, Prague. “These data validate the strategy of combining two monoclonal antibodies targeting CD19 and CD20 with an immunomodulatory agent, potentially establishing a new standard of care for patients with relapsed or refractory follicular lymphoma that is suitable for both academic and community treatment settings.”

As Dr. Trněný reported, follicular lymphoma remains incurable despite advances in treatment, with most patients eventually experiencing relapse after initial therapy. Immunotherapies such as rituximab and lenalidomide have significantly improved outcomes, said Dr. Trněný, but these agents still face limitations in terms of treatment durability.

Tafasitamab has previously demonstrated efficacy in diffuse large B-cell lymphoma, prompting investigation into its potential benefit in follicular lymphoma when combined with lenalidomide and rituximab.

Study Methods

The randomized, double-blind, placebo-controlled, international inMIND trial included 548 patients with relapsed or refractory follicular lymphoma who had received at least one prior systemic therapy including anti-CD20 monoclonal antibodies. Participants were randomly assigned 1:1 to receive either tafasitamab or placebo, both combined with lenalidomide for 12 cycles and rituximab for 4 cycles. Stratification factors included POD24 (disease progression within 24 months of diagnosis) status, refractoriness to previous anti-CD20 therapy, and the number of prior treatment lines.

The primary endpoint was investigator-assessed progression-free survival, with secondary endpoints including overall response rate, complete metabolic response rate assessed by positron-emission tomography, duration of response, time to next treatment, overall survival, and safety.

Significant Improvement in Progression-Free Survival, Secondary Endpoints

As Dr. Trněný reported, the inMIND study met its primary endpoint, showing significant improvement in progression-free survival with tafasitamab compared with placebo (median = 22.4 vs 13.9 months; hazard ratio = 0.43). The overall response rate was higher with tafasitamab than with placebo (84% vs 72%), and the rate of complete metabolic response also significantly increased with tafasitamab (49% vs 40%).

The duration of response and the time to next treatment also notably favored the tafasitamab arm, said Dr. Trněný. The median time to next treatment was not reached with tafasitamab vs 29 months with placebo.

Safety profiles were similar between both treatment arms, with comparable rates of grade 3 or 4 adverse events (71% with tafasitamab vs 70% with placebo). Neutropenia was the most frequent severe event. Serious adverse events and discontinuations due to adverse events occurred at comparable rates in both groups, highlighting the manageable nature of tafasitamab.

“The benefit [of adding tafasitamab] was consistently observed across all key prespecified patient subgroups, including those with POD24 [status], patients refractory to prior anti-CD20 monoclonal antibody therapies, and individuals previously treated with multiple lines of therapy,” Dr. Trněný concluded. “Although overall survival data remain immature, preliminary analyses suggest a favorable trend with tafasitamab treatment, warranting further long-term follow-up.”

Disclosure: Dr. Trněný reported financial relationships with AbbVie, Amgen, Bristol Myers Squibb, Gilead Sciences, Incyte Corporation, Janssen, MorphoSys, Roche, Takeda, and Celgene.