Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today new magnetic resonance imaging (MRI) data from the Lemtrada (alemtuzumab) clinical development program. In Lemtrada patients from the two Phase III clinical trials (both treatment-naïve patients and patients who had active disease on another therapy), MRI effects observed after two years were maintained during the first year of the extension study. These data, which are being presented today at the 66th American Academy of Neurology (AAN) Annual Meeting, include:
- Consistent effects were seen across key measures of disease activity (gadolinium (gd)-enhancing, T2 hyperintense and T1 hypointense lesion activity) and effects seen after two years of treatment were sustained at year three.
- During the third year of follow-up, more than 70% of patients were free of MRI activity indicative of acute inflammation, defined as gd-enhancing or new or enlarging T2 hyperintense lesions.
- T2 lesion volumes, which reflect the combined burden of permanent brain injury and new lesion formation, increased from year two to three but remained below pre-treatment baseline.
- The rate of atrophy, as measured by brain parenchymal fraction, already reduced after two years, continued to slow in the third year of follow-up.
- Approximately 80 percent of patients treated with Lemtrada did not receive a third course of treatment in the first year of the extension.
“What’s remarkable about these data is that the positive MRI effects of Lemtrada were sustained into the extension study, even though most patients did not receive additional Lemtrada treatment. This observation is unique amongst the current landscape of MS therapeutics,” said Douglas Arnold, M.D., NeuroRx Research and Department of Neurology and Neurosurgery, Montreal Neurological Institute, McGill University. “The new MRI results are an important addition to the clinical data from the extension study that demonstrated Lemtrada’s effect on key measures of clinical disease activity including annualized relapse rates and sustained accumulation of disability.”
The most common side effects of Lemtrada are infusion associated reactions (headache, rash, pyrexia, nausea, fatigue, urticaria, insomnia, pruritus, diarrhea, chills, dizziness, and flushing), infections (upper respiratory tract and urinary tract), and lymphopenia. Autoimmune conditions (including immune thrombocytopenia, other cytopenias, glomerulonephritis and thyroid disease) and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks. Safety results from the first year of the extension study were previously reported for patients who received Lemtrada in the Phase III CARE-MS studies. No new risks were identified. As previously reported, there were two deaths in the extension study. One was from sepsis and the other was presumed accidental and deemed unrelated to study treatment.