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