Ocrevus (ocrelizumab) significantly reduces disease activity and disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive MS (PPMS), according to results of post-hoc analyses of Genentech’s Phase 3 clinical trial program assessing the drug.
Results will be presented at the upcoming 3rd Congress of the European Academy of Neurology (EAN), June 24-27, in Amsterdam, Netherlands.
By revisiting the data from completed clinical trials, researchers assessed a new endpoint considered to be clinically relevant: the “No Evidence of Progression or Active Disease” (NEPAD).
NEPAD means that a patient has no relapses; no confirmed disability progression measured by the Expanded Disability Status Scale (EDSS); no progression equal to or above 20% on the timed 25-foot walk (a mobility and leg function performance test) and the nine-hole peg test (a measure of finger dexterity); and no disease activity in the brain measured through magnetic resonance imaging (MRI).
An analysis of the pooled data from the Phase 3 OPERA I (NCT01247324) and OPERA II (NCT01412333) trials of Ocrevus for treating relapsing MS patients showed that the number of Ocrevus-treated patients who had maintained NEPAD at 96 weeks after treatment was 82% higher than that of patients treated with Rebif (interferon beta-1a), a therapeutic option for MS.
In PPMS, an analysis of the Phase 3 ORATORIO trial (NCT01194570) found that more than three times the number (29.9%) of patients with PPMS treated with Ocrevus maintained NEPAD at 120 weeks compared to patients receiving a placebo (9.4%).
Ocrevus was also found to reduce the risk of MS patients requiring mobility aids. At 96 weeks, patients with relapsing MS who received Ocrevus had a reduced risk of losing the ability to walk long distances unassisted or requiring a cane or crutch compared to patients treated with Rebif. In patients with PPMS, Ocrevus reduced the risk of becoming wheelchair-bound, assessed at 120 weeks, compared to a placebo.
Genentech trials also revealed that Ocrevus reduced the risk of more severe forms of disability progression, assessed through the 12- and 24-week confirmed disability progression (CDP) measure.
“These results underline that the significant effects of OCREVUS on disability progression are clinically meaningful,” said Ludwig Kappos, MD, chair of University Hospital’s Department of Neurology in Basel, Switzerland, in a press release.
“Slowing disability progression, or preventing people with MS from having to use a cane or wheelchair, makes a great difference to their daily lives. It is particularly exciting to see these benefits in people with PPMS, a disabling form of MS without approved treatments in Europe.” Kappos added.
The company also will present interim results from a pilot study called FLOODLIGHT, which evaluates the feasibility of using a sensor-based digital system to remotely monitor patients with MS.
A complete list of Genentech’s presentations on Ocrevus at the EAN can be found at this link.
The U.S. Food and Drug Administration approved Ocrevus, developed by Roche Group member Genentech, on March 28 as a therapy for relapsing MS and PPMS.