Data Supporting Tafasitamab, Lenalidomide, and Rituximab in Second-Line Follicular Lymphoma

The clinical data supporting the addition of tafasitamab to lenalidomide and rituximab as a preferred second-line regimen for follicular lymphoma stems from the pivotal, randomized phase 3 InMIND trial (NCT04680052). This study directly compared the novel triplet combination (tafasitamab, lenalidomide, and rituximab, or Tafa-Len-R) against the established doublet of lenalidomide and rituximab (R-Len).

The InMIND trial met its primary end point by demonstrating a statistically significant and clinically meaningful improvement in disease control. The most crucial finding was the substantial gain in progression-free survival (PFS). Patients treated with the Tafa-Len-R combination achieved a median PFS of 22.4 months, a significant improvement over the 13.9 months observed in the R-Len control arm. This translated to a 57% reduction in the risk of progression, relapse, or death for patients receiving the triplet, confirming its superior efficacy in this setting. The combination also yielded better overall response (OS) rates.

These results led to the triplet being recognized as a recommended regimen for relapsed or refractory follicular lymphoma in the National Comprehensive Cancer Network (NCCN) Guidelines. The combination has not yet achieved the highest level of evidence, NCCN Category 1, primarily due to the relatively short follow-up of the initial data set (around 14 months) and the subsequent lack of mature OS data. While the efficacy based on PFS is robust, the committee requires longer-term OS metrics to assign the Category 1 classification. This underscores the need for continued monitoring, but does not diminish the Tafa-Len-R combination as a preferred treatment choice.