Three studies show clinical significance of Roche's ocrelizumab in MS

Genentech, a unit of Roche (ROG: SIX), has announced results from three studies showing that ocrelizumab was superior to Rebif (interferon beta-1a) from Merck KGaA in patients with relapsing multiple sclerosis.

Ocrelizumab also demonstrated efficacy against placebo in a trial involving patients with primary progressive multiple sclerosis. Roche plans to seek marketing approval for ocrelizumab in both indications in early 2016.

The OPERA I and OPERA II studies, comparing ocrelizumab to Rebif, enrolled 1,656 patients with relapsing multiple sclerosis who were randomly assigned treatment with an intravenous infusion of ocrelizumab every six months, or Rebif, administered by subcutaneous injection three times a week. In these studies, ocrelizumab met the primary endpoint of significantly cutting the annualised relapse rate over a two-year period by 46% and 47% in the OPERA I and OPERA 11 studies respectively. Both studies found that ocrelizumab met the secondary endpoints of significantly delaying confirmed disability progression by approximately 40% sustained through 12 weeks and 24 weeks.