Alemtuzumab: Additional Phase II data

Follow-up data from 195 patients in the open-label, U.S. and European Phase II CAMMS223 trial showed that a significantly greater proportion of patients treated with alemtuzumab were SAD-free at 5 years vs. Rebif interferon beta-1a (87% vs. 62%, p<0.0001). The annualized relapse rate (ARR) for alemtuzumab was 0.11 compared to 0.35 for Rebif at 5 years. Additionally, alemtuzumab improved mean Expanded Disability Status Scale (EDSS) scores from baseline to 5 years by 0.3 points vs. a 0.46 point worsening for Rebif.

A subgroup analysis of 185 patients with highly-active RRMS in the CAMMS223 trial showed that alemtuzumab-treated patients had an 81% lower rate of relapse vs. Rebif at 3 years (p<0.0001). Specifically, the ARR for alemtuzumab was 0.09 compared to 0.46 for Rebif. Additionally, alemtuzumab led to a 70% lower risk for SAD compared to Rebif (p=0.0045), with 91% of alemtuzumab-treated patients SAD-free at 3 years vs. 75% for Rebif. Alemtuzumab also significantly improved mean EDSS scores from baseline to 3 years by 0.53 points vs. a 0.45 point worsening for Rebif (p=0.013). Data were presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Gothenburg. Genzyme previously reported that alemtuzumab met both co-primary endpoints of time to sustained SAD and relapse rate at 3 years vs. Rebif (see BioCentury, Oct. 22, 2007; Oct. 27, 2008; & Sept. 28, 2009). ...