Update on Alemtuzumab (Genzyme’s Lemtrada) Clinical Trial Data Presented at ECTRIMS 2015

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by Patricia Silva PhD |

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Multiple Sclerosis News Today recently attended the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Barcelona, Spain, October 7 to 10, 2015. On Friday, October 9, three parallel sessions entitled “Free Communications” took place. In the first session, several topics related to multiple sclerosis (MS) were discussed including two presentations on the disease-modifying drug alemtuzumab (Lemtrada). Lemtrada is marketed by Genzyme, a Sanofi company.

The first talk was given by Prof. Frederic Barkhof from the VU University Medical Centre in Amsterdam, The Netherlands and was entitled “Alemtuzumab slows brain volume loss over 5 years in patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE MS I and II extension study.

Alemtuzumab has been previously shown to have superior efficacy compared to subcutaneous interferon beta-1a injection in patients with relapsing-remitting MS (RRMS) over a period of two years, and to significantly slow brain volume loss (atrophy, a net effect of neurodegeneration) by 42% in patients under active treatment (CARE-MS I phase 3 study, NCT00530348) and by 24% in patients who had an inadequate response (one or more relapses) to a prior therapy (CARE-MS II phase 3 study, NCT00548405). Alemtuzumab (12 mg) was administered in two annual occasions, at month 0 and month 12 of the studies, and its effects were reported to be sustained for at least four years.

An extension study (NCT00930553) was conducted with 95% of the participants in CARE-MS I (349 patients) and 93% from CARE-MS II (393 patients). Prof. Barkhof showed that, “The slowing of brain volume loss in alemtuzumab patients was maintained through 5 years,” despite the fact that most patients had not received additional treatment over the previous 4 years. The median annual brain volume loss in both studies was reported to be less than 0.2% in years 3, 4 and 5.

Prof. Barkhof explained that it is thought that when “alemtuzumab binds to CD52, a cell surface antigen present on T and B lymphocytes, depleting circulating T and B cells” over time, lymphocytes repopulate. In his presentation, Prof. Barkhof suggested that the durable effect of alemtuzumab in terms of brain volume change in RRMS patients may result from a reduction in inflammation and the immunomodulatory effects of distinct lymphocytes, which re-populate after alemtuzumab treatment.

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The second presentation of the session focused on alemtuzumab was given by Prof. Eva Havrdová from the Charles University in Prague, Czech Republic – “Durable efficacy of alemtuzumab on clinical outcomes over 5 years in treatment-naïve patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE-MS I extension study.

Prof. Havrdová confirmed the results presented by Prof. Barkhof, especially in RRMS patients who enrolled in the CARE-MS I clinical trial. Furthermore, Prof. Havrdová showed that the incidence of adverse events, such as infusion-associated reactions and infections, during the extension study was reduced when compared with the core study, with a low incidence of serious adverse events.

Concerning the adverse events in the CARE MS I study, Prof. Havrdová concluded, “infection rate was highest after the first treatment course, serious infection was low; there were some autoimmunity events and only one death.”

All the studies mentioned were supported by Genzyme and Bayer Healthcare Pharmaceuticals.

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