Sanofi's Genzyme unit announced Thursday that the positive effects of Lemtrada (alemtuzumab) seen in two-year studies for patients with relapsing remitting multiple sclerosis (RRMS) were maintained through three additional years in an extension trial. Bill Sibold, head of Genzyme’s MS business, remarked "the five-year data...are exciting and important for people living with relapsing MS, because of Lemtrada’s potential to change the treatment approach for patients."
The extension trial included more than 90 percent of patients who were treated with Lemtrada in the CARE-MS Phase III trials, which compared Genzyme's drug to Merck KGaA's Rebif (interferon beta-1a) in subjects with RRMS who had active disease and were either new to treatment or who had an inadequate response to another therapy. In the extension study, patients were eligible to receive additional treatment with Lemtrada if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions.
Results showed that the low annualised relapse rates observed in patients who received Lemtrada in the CARE-MS trials, which were 0.18 and 0.27, were maintained from year three, at 0.19 and 0.22, to year five, at 0.15 and 0.18. Genzyme noted that through year five, 80 percent and 76 percent of patients who received Lemtrada in the two CARE-MS studies did not experience worsening of disability progression confirmed over six months as measured by the Expanded Disability Status Scale (EDSS).
Further results demonstrated that through year five, 33 percent and 43 percent of patients who had some disability before receiving Lemtrada in the two CARE-MS studies had improvement in EDSS score confirmed over at least six months as compared with pre-treatment baseline. In addition, through year five, patients who received Lemtrada in the two trials experienced a slowing of brain atrophy as measured by brain parenchymal fraction on magnetic resonance imaging. Genzyme said that in years three, four and five, the median yearly brain volume loss was 0.20 percent or less, which was lower than that seen during the two-year pivotal studies.
According to the company, the incidence of most adverse events during the extension study was comparable or reduced compared with the pivotal studies. The results will be presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
