Lenalidomide Plus Rituximab Maintains Survival Benefit in R/R Indolent Non-Hodgkin Lymphomas
Clinical Summary:
- Design/Population: Long-term follow-up analysis of the phase 3 AUGMENT trial evaluated lenalidomide plus rituximab in patients with relapsed/refractory indolent non-Hodgkin lymphoma, including a subgroup with follicular lymphoma aged ≥70 years.
- Key Outcomes: Lenalidomide plus rituximab improved progression-free and overall survival compared with rituximab plus placebo, with durable benefit and manageable long-term safety.
- Clinical Relevance: These findings continue to support lenalidomide plus rituximab as a standard-of-care option for relapsed/refractory indolent non-Hodgkin lymphomas, including older adults.
Long-term follow-up results from the phase 3 AUGMENT trial demonstrated that lenalidomide plus rituximab sustained survival benefit among adult patients with relapsed or refractory (R/R) indolent non-Hodgkin lymphomas (NHL).
In this study, 358 previously treated adult patients with indolent NHLs including follicular lymphoma (FL) were randomized 1:1 to receive rituximab plus either lenalidomide (n = 178) or placebo (n = 180) for up to 12 cycles or until relapse, disease progression, or unacceptable toxicity.
The primary end point was investigator-assessed progression-free survival (PFS). Key secondary end points included overall survival (OS) and safety. End points were assessed in the intention-to-treat population, as well as in patients with FL (lenalidomide n = 147; placebo n = 148) and in patients with FL aged ≥70 years (lenalidomide n = 34; placebo n = 32).
At a median follow-up of 65.9 months, median PFS was 27.6 months in the rituximab plus lenalidomide arm and 14.3 months in the rituximab plus placebo arm. Median OS was not reached in either treatment arm. Any-grade treatment-emergent adverse events were reported in 99% of patients in the rituximab plus lenalidomide arm and 96% of patients in the rituximab plus placebo arm. Grade 3/4 treatment-emergent adverse events were reported in 69% and 32% of patients, respectively.
Among patients with FL, median PFS was 30.4 months in the rituximab plus lenalidomide arm and 13.9 months in the rituximab plus placebo arm. Among patients aged ≥70 years, median PFS was 32.3 months and 16.6 months, respectively. Median OS was not reached in either treatment arm among patients aged <70 years. Among patients aged ≥70 years, median OS was not reached in the rituximab plus lenalidomide arm and was 70.1 months in the rituximab plus placebo arm.
Among patients aged ≥70 years, any-grade treatment-emergent adverse events were reported in 100% of patients in the rituximab plus lenalidomide arm and 94% of patients in the rituximab plus placebo arm. Grade 3/4 treatment-emergent adverse events were reported in 68% and 34% of patients, respectively.
“These data continue to support [rituximab plus lenalidomide] as a standard of care for patients with R/R [indolent] NHL, an important benchmark for new approaches, and an attractive platform on which to build with the addition of novel agents,” concluded Dr Leonard et al.
Source:
Leonard J, Trneny M, Zhang H, et al. Lenalidomide plus rituximab for relapsed/refractory indolent non-Hodgkin lymphoma: 5-year follow-up and subgroup analyses from the phase III AUGMENT trial. J Clin Oncol. Published online: April 16, 2026. doi:10.1200/JCO-25-01770
