- In patients with relapsed or refractory indolent non-Hodgkin lymphoma, the addition of lenalidomide to rituximab significantly improved PFS without a meaningful effect on safety.
Why this matters
- Rituximab monotherapy is a common treatment in this setting.
- Phase 3 AUGMENT study to investigate lenalidomide+rituximab vs placebo+rituximab in patients with marginal zone lymphoma (n=63) or follicular lymphoma (n=295).
- Median patient age, 63 (range, 26-88) years.
- Funding: Celgene Corporation.
- Median PFS with lenalidomide+rituximab, 39.4 months (95% CI, 22.9-not reached [NR]) vs 14.1 (95% CI, 11.4-16.7) months with placebo+rituximab (HR, 0.46; 95% CI, 0.34-0.62; P<.001>
- Overall response rate with lenalidomide+rituximab, 78% (95% CI, 71%-83%) vs 53% (95% CI, 46%-61%) with placebo+rituximab.
- Complete response with lenalidomide+rituximab, 34% (95% CI, 27%-41%) vs 18% (95% CI, 13%-25%) with placebo+rituximab.
- 69% of patients who received lenalidomide+rituximab and 32% who received placebo+rituximab experienced grade 3/4 adverse events, most of which were neutropenia or leukopenia and were manageable.
- Difference in median PFS by independent review committee (39.4 months) and investigator assessment (25.3 months).