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Lenalidomide plus rituximab improves PFS for lymphoma
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A phase 3 trial evaluating lenalidomide plus rituximab for the treatment of relapsed/refractory indolent lymphoma met its primary endpoint of PFS compared with rituximab plus placebo, according to the agent’s manufacturer.
In the randomized, double-blind AUGMENT trial, the researchers assessed 358 patients with relapsed/refractory follicular and marginal zone lymphoma. Investigators randomly assigned patients to rituximab (Rituxan; Genentech, Biogen) plus lenalidomide (Revlimid, Celgene) or placebo.
The AUGMENT trial achieved its primary endpoint of PFS. In addition, researchers observed a favorable trend in OS for patients treated with lenalidomide plus rituximab. However, the OS data are not mature.
The safety profiled of the combination appeared consistent with the known profiles of the individual medicines. Researchers observed no new safety signals with the combination.
“Indolent non-Hodgkin lymphomas, such as follicular lymphoma and marginal zone lymphoma, are diseases of underlying immune dysfunction with a need for new options beyond currently available therapies,” Jay Backstrom, MD, chief medical officer of Celgene, said in a press release. “We are encouraged by the highly significant improvement in PFS observed in this study and look forward to engaging with regulatory authorities as soon as possible. The [lenalidomide plus rituximab] regimen represents a potentially new chemotherapy-free option for these patients.”
Data from AUGMENT will be submitted for presentation at a future medical meeting.