October 31, 2012
Phase 3 Trial Updates of Lemtrada for Multiple SclerosisGenzyme, a Sanofi company, announced updated results from the Lemtrada (alemtuzumab) Phase 3 CARE-MS I and CARE-MS II pivotal studies in patients with relapsing-remitting multiple sclerosis (MS).
The CARE-MS trials were global, randomized clinical trials designed to evaluate whether the investigational MS therapy Lemtrada could achieve meaningful efficacy and safety improvements over the approved, active comparator Rebif (subcutaneous interferon beta-1a 44mcg; EMD Serono), a standard treatment for relapsing-remitting MS. The CARE-MS I study evaluated 581 patients naïve to prior MS treatment, except for steroids. The CARE-MS II study evaluated 840 patients who have had at least one relapse occurring while on MS therapy, including standard injectable disease modifying therapies.
In both trials, Lemtrada was given as an IV administration a total of eight times over the course of the two-year study. The first treatment course of Lemtrada was administered on five consecutive days, and the second course was administered on three consecutive days 12 months later. Rebif 44mcg was administered by subcutaneous injection three times per week, each week, throughout the two years of study.
In both studies, Lemtrada was significantly superior to Rebif in reducing relapses. In CARE-MS I, 78% of patients treated with Lemtrada remained relapse-free for two years, providing statistically significant improvement over Rebif (77.6% vs. 58.7%, P<0.0001). In the CARE-MS II trial, 65% of patients treated with Lemtrada were relapse-free at two years, compared to 47% with Rebif (P<0.0001). In addition, in CARE-MS II, Lemtrada reduced relapse rate to a greater extent than Rebif in all subgroups defined by previous therapy, including: with or without any interferon therapy, and those previously treated with Rebif or Copaxone (glatiramer acetate injection; Teva Neuroscience).
Study data also showed a strong clinical benefit by reducing the risk of sustained accumulation of disability in patients taking Lemtrada in CARE-MS ll by 42% as compared with Rebif (P=0.008), with significant improvement in disability scores that suggested a reversal of pre-existing disability in some patients. In the trial, the mean disability score for patients treated with Lemtrada decreased over a two-year period, indicating an improvement in their physical disability, while the mean score for patients given Rebif increased, indicating a worsening of disability (P<0.0001).
Alemtuzumab is a monoclonal antibody that selectively targets CD52 on T and B cells, resulting in the depletion of circulating cells thought to be responsible for the damaging inflammatory process in MS. This depletion is followed by a distinctive lymphocyte repopulation.
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