Research Summary

Tafasitamab Added to Lenalidomide–Rituximab Improves Progression-Free Survival in Relapsed or Refractory Follicular Lymphoma

Edited by:
Anthony Calabro, MA

Key Highlights

  • Tafasitamab plus lenalidomide and rituximab significantly prolonged progression-free survival compared with lenalidomide–rituximab alone.
  • Median progression-free survival was 22.4 months with tafasitamab vs 13.9 months with placebo.
  • The trial enrolled patients across North America, Europe, and the Asia–Pacific region.

Follicular lymphoma is marked by repeated cycles of remission and relapse, often necessitating multiple lines of therapy. In a phase 3 randomized controlled trial published in The Lancet, investigators reported that adding tafasitamab to lenalidomide and rituximab significantly improved progression-free survival in patients with relapsed or refractory disease.

The inMIND study was a double-blind, randomized, placebo-controlled trial conducted at 210 centers, including community-based hematology clinics, major hospitals, and academic institutions across North America, Europe, and the Asia–Pacific region. Eligible adults had relapsed or refractory follicular lymphoma and had received at least one prior systemic therapy. Participants were randomly assigned in a 1:1 ratio to receive tafasitamab or placebo, both in combination with lenalidomide and rituximab, for up to 12 cycles of 28 days each. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, with safety assessed in all patients who received at least one dose of study medication.

Study Findings

Between April 16, 2021, and August 10, 2023, 817 patients were screened, and 548 were enrolled and randomized to tafasitamab (n = 273) or placebo (n = 275). The median age and disease characteristics were balanced between treatment groups (men = 55%, women = 45% of patients).

At the planned primary analysis, the addition of tafasitamab resulted in a significantly lower risk of progression, relapse, or death compared with placebo. Median progression-free survival was 22.4 months (95% CI, 19.2 to not evaluable) in the tafasitamab group versus 13.9 months (95% CI, 11.5–16.4) in the placebo group, corresponding to a hazard ratio of 0.43 (95% CI, 0.32–0.58; P < .0001). The progression-free survival benefit was confirmed by an independent review committee.

Adverse events occurred in 99% of patients in both groups. The most common adverse events were neutropenia (49% with tafasitamab vs 45% with placebo) and diarrhea (38% vs 28%, respectively). No deaths due to treatment-related adverse events were reported in the tafasitamab group, while two fatal treatment-related adverse events occurred in the placebo group.

Clinical Implications

According to the study authors, the findings suggest that incorporating tafasitamab into the lenalidomide–rituximab backbone provides a clinically meaningful improvement in progression-free survival with an acceptable safety profile for patients with relapsed or refractory follicular lymphoma.

Expert Commentary

“The addition of tafasitamab to lenalidomide and rituximab resulted in a statistically significant and clinically meaningful improvement in progression-free survival, with an acceptable safety profile in patients with relapsed or refractory follicular lymphoma,” the researchers concluded. “This combination represents a potential new standard-of-care treatment.”

Reference
Sehn LH, Hübel K, Luminari S, et al. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. Published online December 5, 2025. doi:10.1016/S0140-6736(25)01778-