Post hoc analyses of from the Ocrevus (ocrelizumab) phase III clinical trial program for multiple sclerosis.- Genentech

Genentech announced that new post-hoc analyses from the Ocrevus (ocrelizumab) Phase III clinical trial program in people with relapsing and primary progressive forms of multiple sclerosis (RMS and PPMS) will be presented at the 3rd Congress of the European Academy of Neurology (EAN) from June 24 to June 27 in Amsterdam, Netherlands. Ocrevus significantly reduced disease activity and disability progression in patients with RMS and PPMS, as measured by No Evidence of Progression or Active Disease (NEPAD), a novel composite endpoint in MS.

In RMS, Ocrevus significantly increased the proportion of patients maintaining NEPAD by 82 percent compared with Rebif (interferon beta-1a) at 96 weeks in a pooled exploratory analysis of the Phase III OPERA I and II studies (p<0.0001). in ppms patients ocrevus more than tripled the proportion of those who maintained nepad compared with placebo at 120 weeks in an exploratory analysis of the phase iii oratorio study 29.9 percent with ocrevus versus 9.4 percent with placebo p><0.001). nepad is considered a clinically meaningful endpoint because it signifies a patient has no relapses no confirmed disability progression measured by the expanded disability status scale edss no progression equal to or above 20 percent on the timed 25-foot walk t25-fw and the nine-hole peg test 9-hpt no gadolinium-enhancing t1 mri lesions and no new or enlarging t2 mri lesions.>

In separate post-hoc analyses of the OPERA I and II studies , Ocrevus significantly reduced the risk of patients with RMS losing the ability to walk long distances unassisted (EDSS greater than 4) or requiring a cane or crutch (EDSS greater than 6) compared with interferon beta-1a at 96 weeks (p?0.005). In the ORATORIO study , Ocrevus significantly reduced the risk of becoming wheelchair-bound (EDSS greater than 7) compared with placebo at 120 weeks in PPMS patients with baseline EDSS ?6 (p?0.028). Furthermore, in a post-hoc analysis of the placebo-controlled ORATORIO study, Ocrevus consistently reduced the risk of 12- and 24-week confirmed disability progression (CDP) across three different definitions of the measure meant to capture more severe disability worsening than traditionally assessed in PPMS patients.

In addition, interim results from FLOODLIGHT , a sensor-based digital monitoring study to determine adherence and correlation with in-clinic testing in people with and without MS, will be presented. Pregnancy outcomes in all female patients treated with Ocrevus will also be presented. The most common side effects associated with Ocrevus in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.