Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab (Lemtrada™) to Rebif® (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS). New data show that 78 percent of patients treated with alemtuzumab remained relapse-free for two years, providing statistically significant improvement over interferon beta-1a (78 percent vs 59 percent at two years, p<0.0001) and meeting this secondary endpoint. The CARE-MS I results were presented today at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS). Genzyme is developing alemtuzumab for relapsing MS in collaboration with Bayer HealthCare.
“These data support the robust efficacy profile and potential that alemtuzumab offers for patients with relapsing-remitting multiple sclerosis requiring a more effective option than currently available therapies.”
As previously reported, treatment with alemtuzumab resulted in a 55 percent reduction in relapse rate compared to interferon beta-1a over two years of study (p<0.0001), satisfying this co-primary endpoint and meeting the predefined protocol criteria for declaring the study a success. At the two-year time point, very few alemtuzumab patients (8 percent) experienced a sustained increase, or worsening, in disability as measured by the Expanded Disability Status Scale (EDSS) (vs 11 percent of patients in the interferon beta-1a group). However, the difference between groups for this co-primary endpoint was not statistically significant.
The CARE-MS I trial compared treatment with alemtuzumab (12 mg/day by IV administration for 5-days, with a second 3-day IV administration one year later), to treatment with subcutaneous interferon beta-1a (44 mcg administered by injection three times per week) in 581 patients with relapsing-remitting MS who had received no previous treatment to suppress MS, except for steroids.
"CARE-MS I confirms that, in a head-to-head comparison with Rebif, disease activity is significantly reduced in patients with early relapsing-remitting multiple sclerosis treated with alemtuzumab, over the first two years of observation," said Professor Alastair Compston, Chair of the Steering Committee overseeing the conduct of the study and head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom. "These data support the robust efficacy profile and potential that alemtuzumab offers for patients with relapsing-remitting multiple sclerosis requiring a more effective option than currently available therapies."
"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," said David Meeker, M.D., Chief Operating Officer, Genzyme. "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 activity while receiving another MS treatment."
Additional findings from the CARE-MS I study presented today include other secondary endpoints that suggest positive outcomes with alemtuzumab. Improvement in Multiple Sclerosis Functional Composite (MSFC) scores was observed in alemtuzumab-treated patients, as compared to interferon beta-1a (0.12 vs 0.05 mean change from baseline at year two.
The effect of alemtuzumab on reduction in T2-hyperintense lesion volume compared to interferon beta-1a was -9.3 vs -6.5 median percent change at year two.