Genentech’s Ocrevus (ocrelizumab) increased the proportion of patients with no evidence of progression (NEP) in the recently concluded ORATORIO Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS).
The evaluation of NEP — a combined measure of three disability assessments — was a secondary exploratory endpoint of the clinical trial. Researchers presented the results of their analysis today at ACTRIMS 2017 Forum, taking place Feb. 23-25 in Orlando, Florida.
The presentation, “Evaluation of no evidence of progression (NEP) in patients with primary progressive multiple sclerosis in the ORATORIO trial,” was part of the Poster Session 1 and Opening Networking Event on the meeting’s first day.
In the ORATORIO trial (NCT01194570), a total of 230 placebo and 461 Ocrevus-treated PPMS patients were evaluated every 12 weeks for up to 120 weeks. Participants received Ocrevus 600 mg or placebo every 24 weeks. During the study period, non-placebo patients received at least five 600 mg Ocrevus doses.
NEP was defined as having no disability progression as measured by the Expanded Disability Status Scale (EDSS) at 12 weeks, and no confirmed progression of 20 percent or more on the timed 25-foot walk test and on the 9-hole peg test. These tests cover the patient’s overall disability, including both arm function and ambulation. Patients continued evaluations until the end of the study or until researchers recorded a pre-specified number of progressions.
At 120 weeks, 42.7 percent of Ocrevus-treated patients reached NEP, compared to only 29.1 percent among those receiving placebo. The difference represents a 47 percent relative increase in the Ocrevus group.
Researchers also assessed the components of NEP in a pairwise manner. They found that more patients treated with Ocrevus did not experience progression on EDSS in combination with the 25-foot walk test (44.7 percent versus 31.3 percent in the placebo group).
Combining the 25-foot walk test and the 9-hole peg test also revealed a greater proportion in the Ocrevus group (48.4 percent) than in the placebo group (36.1 percent). The smallest change was seen when researchers analyzed EDSS and the 9-hole peg test together; for these parameters, there was only a 15 percent relative increase among Ocrevus-treated (61.4 percent) compared to those receiving placebo (53.5 percent).
The U.S. Food and Drug Administration (FDA) is currently reviewing the Biologics License Approval for Ocrevus in the United States and will likely make its verdict public March 28.