Updated Results from MM-020/IFM 07-01 (First) Study of REVLIMID Presented at European Hematology Annual Congress

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation CELG today announced updated results of its pivotal phase III FIRSTTM (MM-020/IFM 07-01) trial, comparing continuous REVLIMID® (lenalidomide) plus low-dose dexamethasone (continuous Rd) to a fixed duration of 18 cycles of Rd (72 weeks) (Rd18) or 12 cycles of melphalan, prednisone and thalidomide (72 weeks) (MPT) for the treatment of transplant ineligible patients with newly diagnosed multiple myeloma. The results, as part of the Regulatory submissions which led to the REVLIMID® label expansion in the US and EU in February 2015, were presented during the European Hematology Association annual congress. In the study, the primary endpoint was progression-free survival (PFS) and the primary analysis was between continuous Rd and MPT. Overall survival was a secondary endpoint, along with response rate, duration of response, time to response, safety, time to second-line anti-myeloma treatment and best response achieved to second-line anti-myeloma treatment. An updated analysis of progression-free survival (PFS) demonstrated a median of 26.0 months for patients treated with continuous Rd compared with 21.9 months for MPT (HR 0.69 (95% CI, 0.59‐0.80) p=0.00031). The median PFS for Rd18 was 21.0 months. Continuous Rd treatment (doublet regimen) continued to show an OS advantage, with a 25% reduction in risk of death versus the triple-agent MPT regimen in this updated survival analysis (HR 0.75 (95% CI, 0.62‐0.90), translating into a median OS improvement of 10.4 months (from 48.5 to 58.9 months). The median OS for Rd18 was 56.7 months. The median follow up was 45.5 months. "The updated results of the FIRST study reinforce the survival advantage for continuous REVLIMID therapy in patients newly diagnosed with multiple myeloma," said Prof. Thierry Facon, MD, University of Lille and primary investigator of the study. An updated analysis of safety in the continuous Rd arm remained similar with extended follow-up to previously reported data (N Engl J Med 2014). Those data showed that grade 3/4 adverse events that occurred in at least 8% of patients in the continuous Rd arm, Rd18 arm or MPT arm included neutropenia (28%, 26% and 45%, respectively), anemia (18%, 16% and 19%, respectively), thrombocytopenia (8%, 8% and 11%, respectively), febrile neutropenia (1%, 3% and 3%, respectively), leukopenia (5%, 6% and 10%, respectively), infection (29%, 22% and 17%, respectively), pneumonia (8%, 8% and 6%, respectively), deep-vein thrombosis and/or pulmonary embolism (8%, 6% and 5%, respectively), asthenia (8%, 6% and 6%, respectively), fatigue (7%, 9% and 6%, respectively), and peripheral sensory neuropathy (1%, < 1% and 9%, respectively). An updated analysis of the incidence of invasive second primary malignancies was 3.9% in patients taking continuous Rd, 6.1% in patients taking Rd18 and 5.5% in patients taking MPT. The incidence of solid tumors was similar in the continuous Rd and MPT arms (3.4% and 3.3%, respectively) and 5.9% in the Rd18 arm.