Follicular lymphoma (FL) is a cancer that affects lymphocytes. Rituximab plus chemotherapy is routinely prescribed to patients with advanced untreated FL, but most patients end up with a relapse. This study aims to evaluate the efficacy of combination immunotherapy with lenalidomide and rituximab in patients with advanced untreated FL (indolent B-cell non-Hodgkin’s lymphoma).

This international, international, phase 3 superiority trial included a total of 1,030 patients with previously untreated FL. The patients were randomly assigned in a 1:1 ratio to receive rituximab plus lenalidomide (n=513) or rituximab plus chemotherapy (n=517), both followed by maintenance monotherapy. The primary outcomes of the study were complete response at 120 weeks and progression-free survival.

At 120 weeks, the rate of confirmed and unconfirmed complete response was 48% in the rituximab–lenalidomide group and 53% in the rituximab–chemotherapy group. The 3-year rate of progression-free survival was 77% and 78% in the two groups, respectively. The risk of adverse events was higher in the rituximab–lenalidomide group, with commonly occurring events being grade 3 or 4 neutropenia and febrile neutropenia. The risk of grade 3 or 4 cutaneous reactions was higher in the rituximab–chemotherapy group.

The research concluded that in patients with advanced untreated FL, rituximab-lenalidomide, and rituximab-chemotherapy had comparable efficacy but differed in safety profiles.