Genzyme’s Lemtrada Slows Brain Atrophy in Multiple Sclerosis Extension Study

Today, Sanofi’s Genzyme announced its multiple sclerosis (MS) drug Lemtrada slowed brain atrophy in an extension study of a Phase III trial.

The company announced new magnetic resonance imaging (MRI) data from the Lemtrada (alemtuzumab) clinical development program will be presented at the American Academy of Neurology (AAN) Annual Meeting. According to the company, in relapsing remitting multiple sclerosis (RRMS) patients treated with Lemtrada in the Phase III pivotal studies, MRI effects observed in the two-year trials were maintained through two additional years.

After the initial course of treatment in the pivotal studies (CARE-MS I and CARE-MS II) given at months zero and 12, 70 percent of Lemtrada patients did not receive additional treatment during the following three years, through month 48.

Both studies were two-year pivotal studies comparing treatment with Lemtrada to high-dose Rebif (subcutaneous interferon beta-1a) in patients with RRMS. CARE-MS I included patients with RRMS who had active disease and were new to treatment, whereas CARE-MS II included RRMS patients who had an inadequate response to another therapy. Results show that the rate of brain atrophy decreased progressively over four years among Lemtrada patients in CARE-MS I. However, in Lemtrada patients in CARE-MS II, the rate of brain atrophy decreased progressively over three years and remained low in year four. In both studies, the median yearly brain volume loss was less than -0.2 percent in years three and four, which was lower than what was observed during the two-year pivotal studies.

Brain atrophy is seen from the earliest stages of MS and may lead to irreversible neurological and cognitive impairment. Control or prevention of brain atrophy is an important target for MS treatment, since it is associated with disability.

In CARE-MS I and II, Lemtrada treatment significantly reduced the risk of developing new lesions compared to Rebif. In the extension study, most of the patients treated with Lemtrada in both studies were free of new lesions and MRI activity in years three and four.

“It is very promising that most Lemtrada patients experienced slowing of the 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.”

More than 90 percent of the patients treated with Lemtrada in the CARE-MS Phase III trials enrolled in the extension study. These participants were eligible to receive additional treatment with Lemtrada in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions. In CARE-MS I, Lemtrada was significantly more effective than Rebif at reducing annualized relapse rates. In CARE-MS II, Lemtrada was significantly more effective than Rebif at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada versus Rebif.

Source: Genzyme

Last updated: 4/23/15; 2:45pm EST

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