Positive Results Announced from Phase III Clinical Trial of Ocrelizumab in Primary Progressive MS
September 28, 2015
Genentech, a member of the Roche Group, announced that the experimental monoclonal antibody ocrelizumab significantly slowed the progression of disability compared to placebo in a phase III trial.
The study, known as ORATORIO, involved 732 people with primary progressive MS.
There are no approved disease-modifying therapies to treat primary progressive MS, which is characterized by steady worsening of neurologic functioning, without any distinct relapses or attacks, or periods of remission.
The results were announced in a press release which also stated that additional data would be reported at a medical meeting in October, and that it plans to seek marketing approval from the FDA in 2016.
Background: There are no approved disease-modifying therapies to treat primary progressive MS, which is characterized by steady worsening of neurologic functioning, without any distinct relapses or attacks, or periods of remission.
Ocrelizumab binds to a molecule (CD20) on the surface of immune cells called B cells, and depletes them from the circulation. B cells have several functions including making antibodies, and they may play a role in immune-system mediated damage to brain and spinal cord tissues in MS. Previous positive results from two phase III clinical trials of ocrelizumab in relapsing MS were announced earlier this year.
The Study: The trial, called ORATORIO, involved 732 people with primary progressive MS from many parts of the world. Participants were randomly assigned to receive ocrelizumab or placebo (IV infusions every 6 months) and were monitored for worsening of symptoms and other effects. The primary outcome measured was the time to sustained disability progression (an increase in the EDSS disability scale that is sustained for at least 12 weeks). Other outcomes measured included change in timed walk, volume of MS lesions seen on MRI scans, and safety and tolerability.
Results: According to a press release from Genentech, treatment with ocrelizumab significantly reduced the progression of clinical disability compared to placebo. The incidence of infusion reactions and serious infections were similar in the treatment and placebo groups. Results from other assessments were not included in the press release.
The press release stated that additional data would be reported at the European Committee for Treatment and Research in Multiple Sclerosis meeting in October, and that the company plans to seek marketing approval from the FDA in 2016.
Comment: “We look forward to seeing the detailed safety and effectiveness results from this important trial,” says Bruce Bebo, PhD, Executive Vice President, Research at the National MS Society. “This has the potential to be a major advance for people living with primary progressive MS who have waited so long for an effective disease-modifying therapy.”