Progression-Free Survival Improved With Addition of Tafasitamab to Lenalidomide and Rituximab

Adding tafasitamab (Monjuvi; Incyte) to lenalidomide (Revlimid) and rituximab (Rituxan) resulted in a 57% reduction in investigator-assessed risk of progression, relapse, or mortality in patients with relapsed or refractory (R/R) follicular lymphoma (FL), according to results from the inMIND trial, which were presented at the 66th ASH Annual Meeting and Exposition held in San Diego, CA.¹

Tafasitamab is a humanized CD19-directed monoclonal antibody (mAb) that induces direct cytotoxicity and enhances NK cell and macrophage immune-mediated mechanisms. It is currently indicated to be used in combination with lenalidomide in the United States and Europe for treating patients with RR diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplantation.

Adult patients with R/R CD19+ and CD20+ FL and an ECOG performance status of 2 or lower, who required treatment after at least 1 prior systemic therapy that included an anti-CD20 mAb, were randomly assigned in a 1-to-1 fashion to receive either tafasitamab or a placebo on days 1, 8, 15, and 22 for the first three 28-day cycles, and on days 1 and 15 of cycles 4 to12, in combination with standard doses of lenalidomide and rituximab for up to twelve 28-day cycles.

Investigator-assessed progression-free survival (PFS), with analysis planned after 174 events, was the primary end point of the study. Additional end points included complete response rate assessed by PET scans in FDG-avid patients, overall survival (OS), and others.

The researchers noted a “significant and clinically meaningful improvement in PFS, representing a 57% reduction in risk of progression, relapse, or death in patients with R/R FL. Although OS data are immature, a trend in favor of tafasitamab was observed. The safety profile was manageable and consistent with expected toxicities.”

“This late-breaking presentation provides valuable insights into the potential role of tafasitamab in improving outcomes for FL patients who currently face limited effective treatment options,” said President and Head of Research and Development of Incyte Pablo J. Cagnoni, MD, in a press release about the findings.²

References

1. Sehn LH, Luminari S, Scholz CW, et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Presented at: 66th ASH Annual Meeting and Exposition. December 7-10, 2024; San Diego, CA. Abstract LBA-1.
2. Incyte to spotlight new data, including a late breaking oral presentation for tafasitamab in follicular lymphoma, at the 2024 ASH Annual Meeting. Press release. Business Wire. Published November 25, 2024. Accessed December 3, 2024. www.businesswire.com/news/home/20241125630696/en/Incyte-to-Spotlight-New-Data-Including-a-Late-Breaking-Oral-Presentation-for-Tafasitamab-in-Follicular-Lymphoma-at-the-2024-ASH-Annual-Meeting