Photo Credit: Nemes Laszlo
A treatment regimen of tafasitamab plus lenalidomide and rituximab outperformed lenalidomide plus rituximab and a placebo in patients with relapsed or refractory follicular lymphoma in a phase 3 study, representing a potential new standard of care.
The phase 3 inMIND study (NCT04680052) enrolled 548 patients with relapsed or refractory follicular lymphoma and randomly assigned participants 1:1 to either the CD19-targeting monoclonal antibody tafasitamab or a placebo; both groups also received standard dosing of lenalidomide and rituximab1. Progression-free survival (PFS) was the primary outcome.
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, meeting the trial’s primary endpoint (HR 0.43; 95% CI 0.32–0.58; P<0.0001). “This result was consistent in participants with a POD24 status, in participants who were refractory to anti-CD20 therapy, and in participants who had received two or more prior lines of therapy,” added Laurie Sehn, MD, MPH, from the University of British Columbia, in Canada. The overall survival data were not yet mature and will be evaluated at 5 years of follow-up.
Neutropenia was the most common grade 3 or higher AE in both groups (39.8% vs 37.5%). “The occurrence of grade 3 or 4 pneumonia (8.4% vs 5.1%) and grade 3 or 4 COVID-19 (5.8% vs 2.2%) was numerically higher in the tafasitamab arm,” said Dr. Sehn. Besides these events, the safety profiles of the treatment regimens were comparable, according to Dr. Sehn.
“This is the first study to validate the approach of combining two antibodies for treating follicular lymphoma,” mentioned Dr. Sehn. “Tafasitamab plus lenalidomide and rituximab can be administered in the community setting and in the academic setting and has the potential to become a new standard of care for patients with relapsed or refractory follicular lymphoma.”
Medical writing support was provided by Robert van den Heuvel.
Copyright ©2024 Medicom Medical Publishers
