AUGMENT phase III 5-year follow-up: Lenalidomide + rituximab in R/R iNHL

Results from the 5-year follow-up of the phase III AUGMENT study (NCT01938001), evaluating lenalidomide + rituximab (R2) vs rituximab + placebo (R-placebo) in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL; N = 358), were published in the Journal of Clinical Oncology by Leonard et al. Endpoints included progression-free survival (PFS) and overall survival (OS), and prespecified subgroup analyses included patients with follicular lymphoma (FL; n = 295), including those aged ≥70 years (n = 66).

Key data: At a median follow-up of 65.9 months, median PFS was 27.6 months in the R2 group vs 14.3 months in the R-placebo group (hazard ratio [HR], 0.50; 95% confidence interval [CI], 0.38–0.66). In patients with FL, median PFS was 30.4 months with R2 vs 13.9 months with R-placebo (HR, 0.43; 95% CI, 0.32–0.59). In patients aged ≥70 years with FL, median PFS was 32.3 vs 16.6 months (HR, 0.62; 95% CI, 0.33–1.17) in the R2 and R-placebo groups, respectively. While the median OS was not reached (NR) in either arm of the intent-to-treat (ITT) population, there was an improvement with R2 vs R-placebo (HR, 0.59; 95% CI, 0.37–0.95). Median OS was NR in either arm in the FL cohort. In patients aged ≥70 years with FL, OS was NR in the R2 group and was 70.1 months in the R-placebo group. Any grade treatment-emergent adverse events (TEAEs) occurred in 99% and 96% of patients in the R2 and R-placebo groups, respectively, and Grade 3/4 TEAEs occurred in 69% and 32% of patients, respectively.

Key learning: At 5 years of follow-up, R2 demonstrated superior PFS and OS vs R-placebo, with a manageable safety profile, supporting R2 as a standard of care (SoC) therapy for patients with R/R iNHL, including older populations.