Sanofi and Genzyme Report New Positive Data from First Phase III Study with MS Drug

Sanofi and its Genzyme subsidiary reported positive new results from the first of two Phase III studies comparing alemtuzumab (Lemtrada™) with Rebif® (high-dose subcutaneous interferon beta-1a) in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). The new CARE-MS I study data showed that 78% of patients treated using alemtuzumab remained relapse-free for two years, whereas 59% of Rebif-treated patient remained relapse-free at two years.

Additional new secondary endpoint data from the CARE-MS I study included a greater impact of alemtuzumab therapy (compared with Lemtrada) on reduction in T2 hyperintense lesion volume, and fewer patients demonstrating new and enlarging T2 hyperintense lesions. Alemtuzumab therapy also more effectively reduced changes in brain parenchymal fraction (a measure of brain atrophy).

Alemtuzumab is a CD52-targeting humanized monoclonal antibody. The CARE-MS I study included 581 patients with RRMS who had received no previous treatment to suppress their disease, except steroids. Previously reported data from the study have shown that alemtuzumab therapy resulted in a 55% reduction in relapse rate compared with interferon beta-1a therapy over the two year course of study.  

“Lemtrada’s robust effects over and above those of Rebif on relapses and a variety of clinical and imaging endpoints reinforces its potential as an effective treatment option for MS patients,” comments David Meeker, M.D., Genzyme CEO. “We look forward to the results of CARE-MS II, our second Phase III study, later this year to extend these results by confirming Lemtrada’s effects in patients with continued disease while receiving another MS treatment.” This CARE-MS II study is evaluating alemtuzumab in comparison with interferon beta-1a therapy, in RRMS patients who have relapsed while on therapy.

Submission of alemtuzumab marketing applications in the U.S. and Europe are expected during the first quarter of 2012. The drug has been granted fast track designation by FDA.