The FDA has granted Priority Review to Celgene’s application for lenalidomide in combination with rituximab for previously untreated follicular lymphoma.
The US Food and Drug Administration has granted Priority Review to Celgene’s application for lenalidomide in combination with rituximab for previously untreated follicular lymphoma and marginal zone lymphoma.
The application is based on results of the phase III AUGMENT study in which combination lenalidomide/rituximab significantly improved progression-free survival compared with rituximab plus placebo. These results were previously presented at the 2018 American Society of Hematology (ASH) Annual Meeting.
The trial included 358 patients (295 with follicular lymphoma) who were randomly assigned to lenalidomide/rituximab or rituximab plus placebo. With a median follow-up of 28.3 months, the median progression-free survival was 39.4 months for the combination compared with 14.1 months for rituximab alone (P = .001). The median duration of response was longer than 3 years for combination treatment compared with less than 2 years for rituximab alone (36.6 vs 21.7 months; P = .0007).
At 2 years, the overall survival rate was 93% in the combination arm compared with 87% for rituximab alone (hazard ratio [HR], 0.61; 95% CI, 0.33–1.13).
About 70% of patients in the combination arm reported grade 3/4 treatment-emergent adverse events (TEAEs) compared with only about one-third of patients assigned to rituximab alone. TEAEs occurring more commonly with lenalidomide/rituximab included neutropenia (50% vs 13%) and leukopenia (7% vs 2%).
Jonathan W. Friedberg, MD, director of the Wilmot Cancer Institute at the University of Rochester, told Cancer Network that lenalidomide has been shown in several settings to have significant activity in follicular lymphoma.
The randomized RELEVANCE trial, which compared lenalidomide/rituximab with chemotherapy in newly diagnosed follicular lymphoma, demonstrated equivalence of the two regimens.
“The trial was written as a superiority trial, so it was technically negative; however, the fact that lenalidomide with 3 years’ follow-up did as well as chemotherapy suggests it is very active,” Friedberg said.
“Importantly, in the AUGMENT trial, there was fixed duration of treatment-patients were not on lenalidomide forever,” Friedberg said. “There was more toxicity associated with lenalidomide than rituximab, but the toxicity was very manageable and mainly cytopenias that could be dealt with by adjusting doses of lenalidomide or using occasional growth factors.”
“Lenalidomide will be an important addition to the therapeutic armamentarium in follicular lymphoma,” concluded Friedberg.