, a Sanofi Company (EURONEXT: SAN and NYSE: SNY),
announced today interim results from the first year of the extension study of LEMTRADA™ (alemtuzumab), being developed for the treatment for multiple sclerosis (MS).
In this analysis of the first year of the extension study, relapse rates and sustained accumulation of disability remained low among patients who had previously received LEMTRADA in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, LEMTRADA was given as two annual courses, at the start of the study and 12 months later. More than 80 percent of patients did not receive further treatment with LEMTRADA during the first year of the extension study.
“These findings are important because they suggest that the benefits of LEMTRADA as observed in the Phase III studies are maintained, even though most patients did not receive further dosing,”
said Edward Fox, M.D., Director of the Multiple Sclerosis Clinic of Central Texas, who presented the study results today at the annual meeting of the American Academy of Neurology in San Diego, Calif.
Extension Study Results
The Phase III trials of LEMTRADA were randomized, two-year pivotal studies comparing treatment with LEMTRADA to Rebif
(subcutaneous interferon beta-1a 44 mcg) in patients with relapsing-remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
More than 90 percent of the patients who participated in the Phase III pivotal trials enrolled in the extension study. Patients who originally received LEMTRADA were eligible to receive additional treatment in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal lesions.
These interim results are from the first year of the extension study for patients who previously received LEMTRADA in the two-year studies. Findings stated below are based on patients who enrolled in the extension study:
“These results underscore the tremendous promise that LEMTRADA holds for MS patients,”
- More than half of patients (67 percent in CARE-MS I and 55 percent in CARE-MS II) who received LEMTRADA in the pivotal trials and enrolled in the extension study were still relapse-free through the first year of the extension study.
- In the first year of the extension phase, the annualized relapse rate for patients who received LEMTRADA in the pivotal trials was 0.24 and 0.25, comparable to the annualized relapse rate for those patients in CARE MS I and CARE-MS II, respectively.
- Through year three, 72.4 percent of patients in CARE MS I and 70.0 percent in CARE MS II had improved or stable disability as measured by EDSS.
- At three years, 88 percent and 80 percent of patients who received LEMTRADA in the pivotal trials, respectively, did not experience six-month confirmed sustained accumulation of disability.
- More than 80 percent of patients treated with LEMTRADA in the pivotal studies did not receive a third course of treatment within a year of entering the extension study.
said David Meeker, M.D., Genzyme’s President and Chief Executive Officer.
“We’re pleased to be able to present these three-year results that provide us with important new information about LEMTRADA and are consistent with the published results from our Phase II extension study.”
Safety results from the first year of the extension study were reported for patients who received LEMTRADA in the Phase III pivotal studies. No new risks were identified. The frequency and type of common and serious adverse events in the first year of the extension study were generally similar to those in the Phase III pivotal studies. The most common adverse events during this period of time were infections, including predominantly mild to moderate upper respiratory and urinary tract infections. There were two deaths. One, as previously reported, was from sepsis. The other death was presumed accidental and deemed unrelated to study treatment. The cumulative incidence of autoimmune thyroid disease over three years was 29.9 percent, as expected based on the Phase II study experience. Additionally, over three years, approximately 1 percent of patients developed immune thrombocytopenia (ITP) and 0.3 percent developed nephropathy, all of whom responded to treatment. These cases were detected early through routine monitoring. Patient monitoring for autoimmune disorders is incorporated in all Genzyme-sponsored trials of LEMTRADA.