Indolent NHL: lenalidomide-rituximab ups PFS in phase 3 trial

  • Leonard JP & al.
  • J Clin Oncol
  • 21 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Difference in median PFS by independent review committee (39.4 months) and investigator assessment (25.3 months).

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit