Success for Revlimid + Rituxan combination in Phase III AUGMENT trial for follicular and marginal zone lymphoma.- Celgene.

Celgene Corporation announced results from a phase III, randomized, double-blind, international clinical study (AUGMENT). Revlimid (lenalidomide) plus rituximab (R2) 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. AUGMENT evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients (N=358) with relapsed/refractory follicular and marginal zone lymphoma.

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 R2 was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified 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," 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 R2 regimen represents a potentially new chemotherapy-free option for these patients."

Data from AUGMENT will be submitted to a future medical meeting and Celgene plans to prepare global regulatory submissions in the first quarter of 2019. Revlimid alone or in combination is not approved for use in follicular lymphoma or marginal zone lymphoma in any geography.