Dr. LaCasce Discusses the FDA Approval of Lenalidomide/Rituximab in Non-Hodgkin Lymphoma

Ann S. LaCasce, MD, MMSc, director of Dana-Farber/Partners CancerCare Hematology-Medical Oncology Fellowship Program, institute physician, Dana-Farber Cancer Institute, and associate professor of medicine, Harvard Medical School, discusses the FDA approval of lenalidomide (Revlimid) and rituximab (Rituxan; R²) in non-Hodgkin lymphoma.

On May 28, 2019, the FDA approved the R² regimen of lenalidomide plus rituximab for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL). In the double-blind, phase III AUGMENT trial, patients with relapsed/refractory follicular lymphoma or MZL were randomized to receive either rituximab plus lenalidomide or rituximab alone. Across the study, 295 patients had follicular lymphoma and 63 patients had MZL. Patient had to have received at least 1 prior chemotherapy, immunotherapy, or chemoimmunotherapy regimen, and could not be rituximab-refractory.

Overall survival (OS) data across the entire population showed that at a median follow-up of 28.3 months, the hazard ratio for OS was 0.61 (95% CI, 0.33-1.13). Furthermore, the 2-year OS rate was 93% (95% CI, 87-96) for R² and 87% (95% CI, 81-92) for rituximab alone. The combination will be an effective regimen for patients who relapse early, says LaCasce, and the toxicities of lenalidomide can be easily mitigated.