Genentech announced the new post-hoc data from the Phase 3 program evaluating Ocrevus (ocrelizumab) in patients with relapsing and primary progressive forms of multiple sclerosis (RMS and PPMS). The findings were presented at the 3rd Congress of the European Academy of Neurology (EAN) in Amsterdam, Netherlands.
The post-hoc analyses found Ocrevus to significantly decrease disease activity and disability progression in patients with RMS and PPMS, as assessed by No Evidence of Progression or Active Disease (NEPAD), a new composite endpoint in MS. NEPAD is defined as a patient having no relapses, no confirmed disability progression, no progression ≥20% 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 RMS, Ocrevus significantly increased the proportion of patients maintaining NEPAD by 82% vs. Rebif (interferon beta-1a) at 96 weeks (P<0.0001). In PPMS, Ocrevus increased by more than 3-fold the proportion of those who maintained NEPAD vs. placebo at 120 weeks (29.9% vs. 9.4%; P<0.001).
According to post-hoc analyses of Phase 3 OPERA I and II studies, use of Ocrevus resulted in a significant reduction in the risk of RMS patients losing the ability to walk long distances unassisted (EDSS ≥4) or requiring cane or crutch (EDSS ≥6) vs. interferon beta-1a at 96 weeks. In a separate Phase 3 study, ORATORIO, use of Ocrevus resulted in a significantly reduced risk of becoming wheelchair-bound (EDSS ≥7) vs. placebo at 120 weeks in PPMS patients with baseline EDSS ≤6 (P≤0.28). Ocrevus was also shown to consistently lower the risk of 12- and 24-week confirmed disability progression (CDP) as measured by more strict definitions.
At the EAN Congress, additional data from the sensor-based digital monitoring study (FLOODLIGHT) will be presented as well as pregnancy outcomes in all females treated with Ocrevus.
Ocrevus is a humanized monoclonal antibody that works by targeting CD20-positive B cells, a type of immune cell thought to contribute to myelin and axonal damage. It is available as 300mg/10mL single-dose vial for intravenous (IV) infusion.
For more information call (844) 627-3887 or visit Ocrevus.com.