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Detailed Clinical Trial Results Published On Ocrelizumab for Primary Progressive and Relapsing MS

December 22, 2016

SUMMARY
  • Results from three clinical trials of the experimental therapy ocrelizumab have been published, showing benefits in people with primary progressive and relapsing MS and providing additional details regarding effectiveness and safety, after preliminary findings were reported at medical conferences.
  • The trial in primary progressive MS is the first large-scale clinical trial to show positive results in people with primary progressive MS.
  • The studies were published in two papers in the December 21, 2016 issue of the New England Journal of Medicine: “Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis” (Dr. Xavier Montalban and others); “Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis” (Dr. Stephen Hauser and others). 
  •  Regulatory agencies are now evaluating these results. The U.S. Food and Drug Administration is expected to make an approval decision by March 28, 2017.
DETAILS
Results from three clinical trials of the experimental therapy ocrelizumab (proposed brand name, Ocrevus,™ Genentech, a member of the Roche Group) have been published, showing benefits in people with primary progressive and relapsing MS and providing additional details regarding effectiveness and safety, after preliminary findings were reported at medical conferences. The trial in primary progressive MS is the first large-scale clinical trial to show positive results.
 
“If the FDA approves this treatment, it will a breakthrough for people living with primary progressive MS, who have waited so long for an effective disease modifying therapy,” commented Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “We hope that this success will encourage others to focus more resources into the research and development of treatments for progressive forms of MS.”
 
Dr. Bebo added, “The results from the trial of ocrelizumab in relapsing MS have revealed a new approach to suppressing disease activity. The possibility of another effective disease modifying treatment option for people living with relapsing MS is very encouraging.”
 
About Ocrelizumab
Ocrelizumab is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and reduces the numbers of certain B cells that are circulating in the blood. B cells have several functions including making antibodies, and they are believed to play a role in immune-system-mediated damage to brain and spinal cord tissues in MS. Ocrelizumab is administered by intravenous infusion every 6 months.
 
Potential Benefits
Primary Progressive MS: The ORATORIO study compared ocrelizumab to inactive placebo in people with primary progressive MS for a minimum of 120 weeks. Of 732 participants, 488 were randomly assigned to receive ocrelizumab and 244 received inactive placebo. The trial was successful at meeting its primary endpoint, showing treatment with ocrelizumab significantly reduced the risk of progression of clinical disability by 24% compared with placebo. This reduced risk of progression means that people taking ocrelizumab in the trial were 24% less likely to demonstrate worsening of disability than those taking placebo. Other secondary benefits showed that compared to placebo, ocrelizumab reduced the time required to walk 25 feet, decreased the volume of brain lesions and reduced the rate of brain atrophy (shrinkage).
 
Relapsing MS: In the OPERA I and OPERA II studies involving people with relapsing MS, which compared ocrelizumab to interferon beta-1a (Rebif,® EMD Serono and Pfizer), ocrelizumab significantly reduced the annualized relapse rate by up to 47% compared with Rebif over two years in a total of 1,656 people with relapsing MS. Ocrelizumab also significantly delayed confirmed progression of disability, and reduced active inflammation and total damage on MRI scans compared with Rebif.

Potential Risks
The most common adverse events associated with ocrelizumab in all three trials were mild to moderate infusion-related reactions. Infusion reactions varied, the most frequent being itchy skin, rash, irritation in the throat, flushed face or fever, headache or other symptoms. These reactions decreased and tended to be less severe with subsequent doses. Serious infections occurred at similar rates in treatment and placebo groups. Other less severe infections included flu and oral herpes. A small percentage of participants who took ocrelizumab developed cancers during or after the trial more than those on placebo. This occurrence “warrants ongoing evaluation,” noted the authors of both papers. Extension studies now underway should help track safety and longer-term benefits.
 
There are extension studies involving participants of the clinical trials, plus additional clinical studies taking place which are currently recruiting individuals with MS who meet specific criteria. All participants receive the active therapy, and there is no placebo group. Individuals may contact Genentech about these studies at: 888-662-6728
 
The studies were published in two papers in the December 21, 2016 issue of the New England Journal of Medicine: “Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis” (Dr. Xavier Montalban and others); “Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis” (Dr. Stephen Hauser and others). 
 
What’s Next?
The U.S. Food and Drug Administration and the European Medicines Agency are evaluating these results. The FDA is expected to make an approval decision by March 28, 2017. No approval date has been published for the European review. 
 
Read recent news about ocrelizumab
 
Ocrevus is a trademark of Genentech, a member of the Roche Group.
Rebif is a registered trademark of EMD Serono and Pfizer.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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