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inMIND: Positive phase 3 results for tafasitamab combination in FL

Presented by
Prof. Marek Trneny, Charles University, Czech Republic
Conference
EHA 2025
Trial
Phase 3, inMIND
The combination of tafasitamab, lenalidomide, and rituximab yielded clinically relevant benefits in survival outcomes in patients with relapsed or refractory follicular lymphoma (FL). Together with an acceptable safety profile, this regimen may potentially represent a new standard-of-care option for this indication.

The phase 3 inMIND study (NCT04680052) randomised 548 participants with FL 1:1 to the CD19-targeting monoclonal antibody tafasitamab plus lenalidomide and rituximab, or to placebo plus lenalidomide and rituximab [1]. The included patients had received at least 1 prior systemic therapy, including an anti-CD20 monoclonal antibody. The primary endpoint was progression-free survival (PFS), and Prof. Marek Trneny (Charles University, Czech Republic) presented the results.

After a median follow-up of 14.1 months, the median PFS was 22.4 months in the tafasitamab arm and 13.9 months in the placebo arm (HR 0.43; 95% CI 0.32–0.58; P<0.0001). “This effect was consistent across POD24 status, refractoriness to prior anti-CD20 therapy, and the number of previously administered therapies,” added Prof. Trneny. Serious adverse events (AEs) were reported in 36% and 32% of participants in the experimental arm and control arm, respectively. Neutropenia (40%; 38%) was the most common grade 3 or 4 AE in both arms, and 11% and 7% of participants discontinued the study due to treatment-emergent AEs.

“We observed an improved PFS and a trend towards an improved overall survival for patients in the tafasitamab arm,” Prof. Trneny summarised. “The combination therapy can be administered in community and academic settings, potentially providing a feasible option for the relapsed/refractory FL population.”

  1. Trneny M, et al. Tafasitamab plus lenalidomide and rituximab for patients with relapsed or refractory follicular lymphoma: results from the phase 3 INMIND study. S230, EHA2025 Congress, 12–15 June, Milan, Italy.

Medical writing support was provided by Robert van den Heuvel.
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