As the FDA continues its review of the Biologics License Application (BLA) for Genentech’s Ocrevus (ocrelizumab), key phase 3 findings reviewing the agent’s safety and efficacy in relapsing and primary progressive multiple sclerosis (MS) have been published in The New England Journal of Medicine (December 21).
In two identical studies known as the OPERA trials, the annualized relapse rate was lower in patients treated with 600 mg ocrelizumab every 24 weeks for 96 weeks than with interferon beta-1a. Moreover, the percentage of patients with disability progression was significantly lower with ocrelizumab than with interferon beta-1a at both 12 and 24 weeks. Regarding adverse events, infusion-related reactions occurred in 34.3 percent of the patients treated with ocrelizumab, the researchers observed. Serious infections, however, were lower in the ocrelizumab group. The researchers concluded that larger and longer studies are needed to better elucidate the safety of ocrelizumab.
In the primary progressive MS trial, the percentage of patients confirmed disability progression at 12 weeks was 32.9 percent in patients treated with ocrelizumab versus 39.3 percent with placebo, while at 24 weeks the percentage of patients with disability progression was 29.6 percent with ocrelizumab versus 35.7 percent with placebo. At the end of the study, performance on the timed 25-foot walk worsened by 38.9 percent in patients treated with ocrelizumab, as compared to 55.1 percent with placebo. Additionally, MRI scans showed a decrease in total volume of brain lesions of 3.4 percent in the ocrelizumab group and an increased of 7.4 percent in the placebo group. However, infusion-related reactions, upper respiratory tract infections, and oral herpes infections occurred more frequently in patients treated with ocrelizumab than with placebo, the researchers noted. In addition, neoplasms occurred in 2.3 percent of patients who received ocrelizumab and in 0.8 percent of patients who received placebo; there was no clinically significant difference between groups in the rates of serious adverse events and serious infections. For these reasons, the investigators suggested that extended observation is required to determine the long-term safety as well as efficacy of ocrelizumab for primary progressive MS.Next Story