Celgene Announces Additional Results From RELEVANCE

(RTTNews) - Celgene Corp. (CELG) announced additional results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented at the 54th Annual American Society of Clinical Oncology Scientific Sessions (ASCO) in Chicago, Illinois.

The investigational study evaluated REVLIMID (lenalidomide) plus rituximab (R2), followed by R2 maintenance, an investigational regimen, compared to the standard of care treatment of rituximab plus chemotherapy (R-chemo: R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma.

Investigators found that treatment with a chemotherapy-free R2 regimen offered numerically similar efficacy results for the primary endpoints of progression free survival (PFS) and complete response or unconfirmed complete response (CR/CRu) at 120 weeks with a different safety profile than treatment with the conventional R-chemo standard.

The co-primary efficacy endpoints of the study were CR and CRu at 120 weeks and PFS during the pre-planned analysis (final analysis of CR/CRu and interim analysis of PFS). An analysis of the findings found that 48% of patients in the R2 arm and 53% of those receiving R-chemo maintained CR/Cru 120 weeks after randomization, with a 3-year estimated interim PFS rate of 77% and 78% respectively (P=0.48, HR (95% CI) 1.10 (0.85-1.43)).

Preliminary overall survival, one of the study's secondary endpoints, showed a 3-year survival rate of 94% in both treatment arms. Other secondary endpoints included number of patients with adverse events, time to treatment failure, event-free survival, time to next anti-lymphoma treatment, time to next chemotherapy treatment, overall response rate at 120 weeks based on International Working Group (IWG) 1999 criteria, and health-related quality of life as measured by the EORTC QLQ-C30.