Celgene Announces Phase III ‘AUGMENT’ Study of REVLIMID® in Combination with Rituximab (R2) for the Treatment of Patients with Relapsed/Refractory Indolent Lymphoma Met Primary Endpoint
- Category: Small Molecules
- Published on Tuesday, 24 July 2018 08:23
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Final analysis showed highly statistically significant improvement in progression-free survival for R2 compared with rituximab plus placebo
Global regulatory submissions planned in the first quarter of 2019
SUMMIT, NJ, USA I July 23, 2018 I Celgene Corporation (NASDAQ: CELG) today 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.
REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)
REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.