New Phase III data analyses show Ocrevus (ocrelizumab) may provide meaningful disability benefits such as delay in the need for a wheelchair for people with primary progressive multiple sclerosis. Genentech will be initiating two new global Phase IIIb studies that will evaluate the efficacy of Ocrevus in a broad range of people with progressive forms of MS.

In a new exploratory analysis from the extended control period of the Phase III ORATORIO study in PPMS, Ocrevus may significantly delay the time to need a wheelchair by seven years, as measured by the length of time until a person reaches Expanded Disability Status Scale seven or greater using 24-week confirmed disability progression. People treated with Ocrevus had a 46 percent reduction in the risk of progressing to a wheelchair compared to the placebo-treated group. When these results were extended to calculate the median time-to-wheelchair, the data suggest Ocrevus treatment may delay the need for a wheelchair by seven years.

Additionally, the analysis showed that the placebo-treated patient population studied in ORATORIO had similar disability progression rates to an untreated real-world PPMS population. The extrapolated median time to wheelchair for placebo-treated people in the ORATORIO study was 12.1 years compared to 12.4 years for people with PPMS in the real-world MSBase registry.

The findings will be presented at the 4th Congress of the European Academy of Neurology from June 16-19 in Lisbon, Portugal.

New progressive MS studies initiating in 2018

Many people with progressive MS eventually transition into a wheelchair, which means that maintaining the ability to use their hands and arms is important, especially in later stages of the disease. To advance the clinical understanding of MS progression and the importance of maintaining upper-limb function in people with progressive MS, Genentech will be initiating two new Phase IIIb studies of Ocrevus in 2018.

A first-of-its-kind study, ORATORIO-HAND, will evaluate the long-term safety and efficacy of Ocrevus in people with PPMS later in their disease course and the Nine-Hole Peg Test — a measure of arm, wrist and hand function — will be used as the primary efficacy outcome. A key secondary endpoint is 12-week CDP. This multicenter, randomized, placebo-controlled, double-blind study is planned to start before the end of 2018 and will enroll approximately 1,000 people with PPMS.

The second study, named CONSONANCE, will evaluate the efficacy of Ocrevus in the complete spectrum of progressive MS. The CONSONANCE study will measure the long-term effectiveness of Ocrevus in progressive MS with novel composite disability endpoints, including No Evidence of Progression and No Evidence of Progression or Active Disease, in addition to a wide range of patient-relevant measures and advanced MRI outcomes. The four-year, Phase IIIb study is currently enrolling 600 people with PPMS or SPMS from across 26 countries. The study will also explore whether technology-enabled, continuous sensor-based and self-administered measures may detect changes in disability progression earlier than conventional clinical measures.