Genzyme’s LEMTRADA Maintain’s Effectiveness in Reducing Brain Atrophy According to Recent Study Results

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GenzymeĀ presentedĀ new magnetic resonance imaging (MRI) data from the LemtradaĀ® (alemtuzumab) clinical development programĀ onĀ 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.Ā Through year four, drug side effects were the same as thoseĀ observed during theĀ first two years.

Phase III trials of Lemtrada consisted ofĀ two-year studies comparing Lemtrada withĀ high-dose subcutaneous interferon beta-1a (RebifĀ®). The trials wereĀ called CARE-MS I and CARE-MS II (CARE stands for Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis).Ā In Phase III pivotal studies,Ā Genzyme researchers studiedĀ 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 systemĀ damageĀ (brain atrophy) decreased over four years among Lemtrada patients in CARE-MS I. In the second trial,Ā CARE-MS II, nervous system damage decreasedĀ over three years and wasĀ low in the fourth year. InĀ year three and four, brain volume loss was less thanĀ during the first two-years for both studies. Treatment with Lemtrada in both studies decreased theĀ risk of developing new lesions compared to interferon beta-1a.Ā About 70% of participants had no new lesions in years 3 and 4 for both studies.

ā€œIt 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,ā€ said Dr. Alasdair Coles, Professor, Department of Clinical Neurosciences, University of Cambridge. ā€œThese 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.”

ā€œThe four-year MRI data support the prolonged efficacy of Lemtrada,ā€ said Genzyme President and CEO, David Meeker, M.D. ā€œThese results are encouraging, as they provide further evidence of Lemtradaā€™s potential to change the treatment approach for people living with relapsing forms of MS.ā€

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Most participants in the CARE-MS Phase III trials enrolled in the extension study — a total of 90% of all participants. TheyĀ received additional Lemtrada in the extension study if they hadĀ at least one relapse or at a minimum ofĀ 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 downĀ in people takingĀ Lemtrada compared to those who tookĀ interferon beta-1a at a rate that reached statistical significance.