FDA Approves Lenalidomide in Combination for Previously Treated Follicular and Marginal Zone Lymphomas
Today, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid) in combination with a rituximab product for previously treated follicular and marginal zone lymphoma.
AUGMENT and MAGNIFY Trials
Approval was based on two clinical trials: AUGMENT and MAGNIFY. In AUGMENT, 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomly assigned 1:1 to receive lenalidomide and rituximab or rituximab and placebo. In the single-arm component of MAGNIFY, 232 patients with relapsed or refractory follicular, marginal zone, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab.
In AUGMENT, the primary endpoint was progression-free survival (PFS) in the intent-to-treat population, as determined by an independent review committee (IRC). Median PFS was 39.4 months (95% confidence interval [CI] = 22.9–NE) in the lenalidomide arm and 14.1 months (95% CI = 11.4–16.7) in the placebo-containing arm (hazard ratio [HR] = 0.46; 95% CI = 0.34–0.62; P < .0001). The objective response rate (ORR) by IRC assessment for patients with follicular lymphoma was 80% (118 of 147 patients; 95% CI = 73–86) in the lenalidomide arm compared with 55.4% (82 of 148 patients; 95% CI = 47–64) in the control arm. For patients with marginal zone lymphoma, the ORR by IRC assessment was 65% (20 of 31 patients; 95% CI = 45–81) compared with 44% (14 of 32 patients; 95% CI = 26–62), respectively.
In MAGNIFY, the ORR by investigator assessment was 59% (104 of 177 patients; 95% CI = 51–66) for patients with follicular lymphoma. Median response duration was not reached with a median follow-up of 7.9 months (95% CI = 4.6–9.2). For patients with marginal zone lymphoma, the ORR by investigator assessment was 51% (23 of 45 patients; 95% CI = 36–66). Median response duration was not reached with a median follow-up of 11.5 months (95% CI = 8.0–18.9).
Across both trials, the most common adverse reactions occurring in at least 20% of patients were neutropenia, fatigue, diarrhea, constipation, nausea, and cough.
The prescribing information includes a Boxed Warning alerting health-care professionals and patients about the risk of embryofetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which may be life-threatening or fatal.
The recommended lenalidomide dose for follicular or marginal zone is 20 mg once daily orally on days 1–21 of repeated 28-day cycles for up to 12 cycles.
View the full prescribing information for lenalidomide.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
