The Lymphoma Academic Research Organization (LYSARC) has reported initial data from the phase 3, randomized, double-blind, international REMARC trial. This investigational study evaluated maintenance therapy with lenalidomide (Revlimid, Celgene) compared with placebo in patients with diffuse large B-cell lymphoma (DLBCL) who had responded to first-line rituximab plus CHOP chemotherapy (R-CHOP) induction therapy. LYSARC sponsored the study under a clinical trial agreement with Celgene.
The REMARC trial was a placebo-controlled study designed to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in 650 patients treated with R-CHOP who had responded to induction therapy. The patients had received at least six and up to eight cycles of the R-CHOP 14 or R-CHOP 21 regimen or six R-CHOP 14 or R-CHOP 21 completed by two cycles of rituximab alone in accordance with local preferences. The study’s primary endpoint was PFS. Secondary endpoints included overall survival (OS), event-free survival, the response at the end of maintenance, the improvement in response, and safety.
The study achieved its primary endpoint of a statistically significant improvement in PFS for patients receiving lenalidomide. However, the interim analysis of OS––a key secondary endpoint––showed no benefit in the lenalidomide arm. Based on these interim results, Celgene does not currently plan to seek approval for this indication.
In the United States, lenalidomide in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Lenalidomide is also indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Further, lenalidomide is indicated for the treatment of patients with mantle-cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Lenalidomide is not indicated for the treatment of patients with chronic lymphocytic leukemia outside of controlled clinical studies.
Source: Celgene; July 25, 2016.