Genzyme presented new magnetic resonance imaging (MRI) data from the Lemtrada® (alemtuzumab) clinical development program on April 23, 2015, at the 67th American Academy of Neurology (AAN) Annual Meeting. The company showed that in the extension phase of two Phase III trials (years 3 and 4), the drug continued to protect the nervous system from damage. Through year four, drug side effects were the same as those observed during the first two years.
Phase III trials of Lemtrada consisted of two-year studies comparing Lemtrada with high-dose subcutaneous interferon beta-1a (Rebif®). The trials were called CARE-MS I and CARE-MS II (CARE stands for Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis). In Phase III pivotal studies, Genzyme researchers studied people with relapsing remitting multiple sclerosis (RRMS) treated with Lemtrada. The investigators took magnetic resonance imaging (MRI) measurements to assess nervous system damage.
The scientists found that nervous system damage (brain atrophy) decreased over four years among Lemtrada patients in CARE-MS I. In the second trial, CARE-MS II, nervous system damage decreased over three years and was low in the fourth year. In year three and four, brain volume loss was less than during the first two-years for both studies. Treatment with Lemtrada in both studies decreased the risk of developing new lesions compared to interferon beta-1a. About 70% of participants had no new lesions in years 3 and 4 for both studies.
“It is very promising that most Lemtrada patients experienced slowing of brain atrophy and remained free of new lesions despite receiving their last treatment course three years previously,” said Dr. Alasdair Coles, Professor, Department of Clinical Neurosciences, University of Cambridge. “These new MRI data are consistent with the clinical data from the extension study that provide additional evidence of the sustained efficacy of Lemtrada on both relapses and disability.”
“The four-year MRI data support the prolonged efficacy of Lemtrada,” said Genzyme President and CEO, David Meeker, M.D. “These results are encouraging, as they provide further evidence of Lemtrada’s potential to change the treatment approach for people living with relapsing forms of MS.”
Most participants in the CARE-MS Phase III trials enrolled in the extension study — a total of 90% of all participants. They received additional Lemtrada in the extension study if they had at least one relapse or at a minimum of two new or enlarging brain or spinal cord lesions.
The FDA approved Lemtrada in November of 2014, for relapsing forms of MS. In CARE-MS I, Lemtrada was more effective than interferon beta-1a at reducing relapse — a statistically significant effect. However, slowing of disability progression was not different in the two groups at a level that reached statistical significance. However, in CARE-MS II, Lemtrada was more effective than interferon beta-1a at reducing relapse, and disability was slowed down in people taking Lemtrada compared to those who took interferon beta-1a at a rate that reached statistical significance.