Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID^® (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival (PFS). In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a statistically significant improvement in PFS compared to patients receiving a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).

One of the largest phase III randomized, international studies ever conducted in newly-diagnosed multiple myeloma, MM-020/IFM 07-01 is also known as the FIRST^® (Front-Line Investigation of REVLIMID/Dexamethasone vs. Standard Thalidomide) trial. The international study randomized 1,623 patients who were ineligible for autologous stem cell transplantation to receive continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72 weeks); or melphalan, prednisone and thalidomide for up to twelve 42-day cycles (72 weeks).

The primary endpoint for the study was PFS. Secondary endpoints include overall survival, response rate, quality of life and safety.

The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study are planned to be presented at an upcoming medical meeting.

Based on the results of the FIRST^® study, the Company will commence discussions with regulatory authorities and plans to submit dossiers for registration in the US, Europe and other markets.

These results are from an investigational phase III study. REVLIMID is not approved for the treatment of patients with newly-diagnosed multiple myeloma in any country.