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Revlimid Combo OK’d for Relapsed Indolent Lymphoma

The FDA approved the combination of lenalidomide (Revlimid) and rituximab (Rituxan) on Tuesday for treating relapsed or refractory follicular and marginal zone lymphomas.

Approval for the combination was based on two phase III trials. In AUGMENT, lenalidomide-rituximab led to a 39.4 month median progression-free survival (PFS) compared with 14.1 months for rituximab-placebo (HR 0.46, 95% CI 0.34-0.62, P<0.0001).

While subgroup analyses of PFS showed significant benefit with the combination for the follicular lymphoma group (HR 0.40, 95% CI 0.29-0.56), there was no significant PFS improvement in the marginal zone lymphoma group (HR 1.00, 0.47-2.13).

However, the objective response rate (ORR) in the lenalidomide group versus placebo group, respectively, was improved for both types of lymphoma:

  • Follicular lymphoma (80% vs 55.4%)
  • Marginal zone lymphoma (65% vs 44%)

AUGMENT randomized 358 patients with relapsed or refractory follicular lymphoma (n=295) or marginal zone lymphoma (n=63) to rituximab plus either lenalidomide or placebo.

A second phase III trial, MAGNIFY, also provided support for approval. In this study, ORR in the follicular and marginal zone groups was 59% and 51%, respectively. Duration of response was not reached at a median follow-up of 7.9 months in the follicular group and 11.5 months in the marginal zone group.

Common adverse events in the AUGMENT trial included neutropenia (58%), diarrhea (31%), constipation (26%), cough (24%), fatigue (22%), rash (22%), pyrexia (21%), leukopenia (20%), and pruritus (20%). The FDA also noted that neutropenia, fatigue, diarrhea, constipation, nausea, and cough occurred in at least 20% of patients across both trials. The label will include a boxed warning due to the risk of hematologic toxicity, venous and arterial thromboembolism, and embryo-fetal toxicity.

The combination is also being studied in the RELEVANCE trial, comparing lenalidomide-rituximab with chemoimmunotherapy as a first-line treatment in follicular lymphoma.