Doctor consulting with patient

Results from a phase III, randomized, double-blind, international clinical study (AUGMENT trial | NCT01938001). lenalidomide (REVLIMID?; Celgene) plus rituximab (MabThera?; Roche / Rituxan?; Genentech) achieved a highly statistically significant improvement in the primary endpoint of progression-free survival (PFS), compared to rituximab plus placebo, in the final PFS analysis.

In the AUGMENT trial, researchers evaluated the efficacy and safety of the investigational combination of lenalidomide plus rituximab versus rituximab plus placebo in patients (N=358) with relapsed/refractory follicular and marginal zone lymphoma.

The final analysis showed highly statistically significant improvement in progression-free survival for lenalidomide plus rituximab compared with rituximab plus placebo

In addition to achieving the primary endpoint of the study, a favorable trend was observed for overall survival (OS) during this analysis and follow-up will continue for the mature OS results. The safety profile of lenalidomide plus rituximab was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

Immune dysfunction
“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,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We are encouraged by the highly significant improvement in progression-free survival 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. Global regulatory submissions planned in the first quarter of 2019.

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Lenalidomide in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. De drug alone or in combination is, at this time, not approved for use in follicular lymphoma or marginal zone lymphoma.

[1] Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin’s Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT trial | NCT01938001)

Last Editorial Review: July 23, 2018

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