New analyses from three trials of Ocrevus (ocrelizumab) in primary progressive MS and relapsing MS- Genentech + Roche

Genentech, a member of the Roche group announced new analyses from the three Ocrevus (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented during the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), from September 14-17 in London, England.

Ocrevus increased disease control in patients with RMS and PPMS in separate post-hoc analyses. In these analyses, two composite endpoints measured disease control using a combination of clinical and MRI outcomes: No Evidence of Disease Activity (NEDA) in patients with RMS and No Evidence of Progression (NEP) in patients with PPMS. These composite endpoints are emerging as new treatment targets.A NEDA analysis of pooled data from the Phase III OPERA I and OPERA II studies compared no evidence of disease activity during different time periods over two years of study. NEDA is achieved when a patient has no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions and no new or enlarging MRI lesions.

The data showed that Ocrevus significantly increased the proportion of RMS patients achieving NEDA by 75 percent compared with interferon beta-1a over 96 weeks (0-96 weeks, p<0.0001). additionally compared with interferon beta-1a ocrevus treatment significantly increased the relative proportion of patients achieving neda by 33 percent in weeks 0-24 and by 72 percent in weeks 24-96 both p><0.0001). a majority of patients achieved neda in the first 24 weeks of ocrevus treatment 60.8 percent and this proportion increased during weeks 24-96 of the study 72.2 percent.>

New post-hoc analyses of the ORATORIO study in PPMS patients measured NEP, which includes three measures of physical disability (confirmed disability progression, walking speed and upper extremity function) and reflects no evidence of worsening of a person�s physical disability. Patients who achieved NEP had no evidence of confirmed disability progression sustained for at least 12 weeks and less than 20 percent worsening of performance on the timed 25-foot walk and 9-hole peg test. Ocrevus treatment significantly increased the proportion of PPMS patients with NEP by 47 percent at week 120 compared with placebo (p=0.0006).