Revlimid + rituximab combination fails phase III RELEVANCE study for follicular lymphoma.- Celgene.

Celgene Corporation and the Lymphoma Study Association announced that the Lymphoma Academic Research Organisation (LYSARC) reported results from a phase III, randomized, open-label, international clinical study (RELEVANCE).

This investigational study evaluated Revlimid plus rituximab (R2) followed by R2 maintenance compared to the standard of care with rituximab plus chemotherapy (R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma. The R2 treatment arm did not achieve superiority in the co-primary endpoints of complete response or unconfirmed complete response (CR/CRu) at 120 weeks and progression-free survival (PFS) during the pre-planned analysis (final analysis of CR/CRu and interim analysis of PFS). Neither arm was superior for either of the co-primary endpoints. The safety findings were consistent with the known profiles of the regimens investigated. Additional analyses are ongoing and planned.