As reported in the Journal of Clinical Oncology by Leonard et al, the 5-year follow-up of the phase III AUGMENT trial has shown continued benefit of lenalidomide plus rituximab (R2) vs rituximab with placebo (R-placebo) in patients with relapsed or refractory indolent non-Hodgkin lymphoma.
Study Details
In the double-blind international trial, patients were randomly assigned to receive R2 (n = 178) or R-placebo (n = 180). The primary analysis of the trial showed improved progression-free survival with R2. The 5-year follow-up includes findings in subgroups of patients with follicular lymphoma and those with follicular lymphoma aged 70 years or older.
Key Findings
Among 358 patients in the intent-to-treat (ITT) population, 295 had follicular lymphoma, with 66 aged ≥ 70 years.
At a median follow-up of 65.9 months in the ITT population, hazard ratios for the R2 group vs the R-placebo group were 0.50 (95% confidence interval [CI] = 0.38–0.66) for progression-free survival and 0.59 (95% CI = 0.37–0.95) for overall survival.
Hazard ratios for the R2 group vs the R-placebo group among patients with follicular lymphoma were 0.43 (95% CI = 0.32–0.59) for progression-free survival and 0.62 (95% CI = 0.29–1.30) for overall survival. For patients with follicular lymphoma aged ≥ 70 years, respective hazard ratios were 0.62 (95% CI = 0.33–1.17) and 0.47 (95% CI = 0.18–1.23).
Safety findings were consistent with the primary analysis.
The investigators concluded: "Improved long-term efficacy with R2 vs R-placebo and manageable safety with R2 were observed in patients with follicular lymphoma, including those 70 years and older. With a follow-up of > 5 years, data from the AUGMENT trial continue to support the use of R2 as a standard of care for patients with relapsed or refractory indolent non-Hodgkin lymphoma.”
John P. Leonard, MD, of Perlmutter Cancer Center, NYU Grossman School of Medicine, NYU Langone Health, New York, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by Bristol Myers Squibb. For full disclosures of the study authors, visit ascopubs.org.
