New Reference: Lenalidomide-Rituximab for Indolent Non-Hodgkin Lymphoma

In the phase III AUGMENT trial with 5-year follow-up, lenalidomide plus rituximab significantly improved progression-free survival compared with rituximab plus placebo in patients with relapsed or refractory indolent NHL, including follicular lymphoma and older patients aged 70 and above. Overall survival was also improved in the intent-to-treat population. The safety profile was manageable, with neutropenia being the most common grade 3 or higher adverse event and no new safety concerns observed with extended follow-up.

Study

Double-blind, phase III AUGMENT trial (NCT01938001)

Rel/ref indolent NHL (N=358, 295 with follicular lymphoma {FL})

Lenalidomide plus rituximab (R2, n=178) or rituximab plus placebo (R-placebo, n=180)

Efficacy

mPFS (all pts): 27.6 mos vs 14.3 mos (R2 vs. R-placebo) (HR 0.50 [0.38-0.66])

mPFS (FL): 30.4 mos [22.3-NR] vs 13.9 mos [11.4-16.8] (HR 0.43 [0.32-0.59])

mOS (all pts): NR vs NR (HR 0.59 [0.37-0.95])

OS (FL): NR vs NR (HR 0.62 [0.29-1.30])

Safety

Grade >=3 TEAEs: neutropenia (69% vs 32%), diarrhea

Any-grade TEAEs occurred in 99% with R2 vs 96% with R-placebo

J Clin Oncol 2026;44:1-7

Leonard JP, Trneny M, Zhang H Lenalidomide Plus Rituximab for Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: 5-Year Follow-Up and Subgroup Analyses From the Phase III AUGMENT Trial

http://doi.org/10.1200/JCO-25-01770

Reviewed by Ulas D. Bayraktar, MD on May 15, 2026

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