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Sunday, October 11, 2015

An MS Patient Advocate's Exclusive Interview on Primary Progressive MS ORATORIO trial results with Peter Chin, MD, Principal Medical Director for Genentech-Roche Global Neuroscience Development

Interview on the PPMS ORATORIO Study
By Laura Kolaczkowski—October 11, 2015

The interview begins below all the legalities needed

People with primary progressive multiple sclerosis (PPMS) finally have something to cheer about in a potential disease modifying therapy. Genentech and Roche pharmaceutical companies announced the results of their studies of ocrelizumab in both relapsing remitting MS (RRMS) and PPMS, at the annual conference hosted by the European committee for the treatment and research in MS. (ECTRIMS), held in Barcelona, Spain.

Dr. Peter Chin, Principal Medical Director, for Genentech-Roche Global Neuroscience Development, took time out from the ECTRIMS meetings to discuss these study results with me. To understand the questions, you might first need more background information on ocrelizumab and ORATORIO. Scroll past the background information to get to my exclusive interview with Dr. Chin.

Ocrelizumab is a humanized monoclonal antibody drug, and works by targeting B cells, which may be key to the destruction of the myelin and axonal damage experienced in MS. Ocrelizumab is a cousin of Rituximab, a drug that has quietly been used off-label for hard to treat cases of MS (think PPMS), but not so coincidentally also has a patent expiration date of 2015 (think small profit in generic drugs). Rituximab is commonly used for treating rheumatoid arthritis.

Ocrelizumab was studied in three separate trials named OPERA I, OPERA II, and ORATORIO. The OPERA studies looked at RRMS, and ORATORIO focused on PPMS. The OPERA studies showed positive results and plenty will also be written about them, but we have seen many RRMS drugs come into use over the past five years. We will take a closer look at OPERA results later – for now the spotlight should be on PPMS treatment.
What makes ORATORIO stand out is this is the first drug that has met the desired endpoints in PHASE III clinical trials for PPMS. ORATORIO was a double-blind, randomized study conducted at multiple sites around the world, and the study participants who received the real drug were given 600mg intravenously, in two separate 300mg doses, two weeks apart. There were 732 people in the trial and the study lasted 120 weeks for the subject on either Ocrelizumab or placebo.

The results of this Phase III study showed significant slowing of disease progression through an increase in walking speed, evidence on MRI with fewer lesions, and slowed brain volume loss.

The criteria for the study participants can be found through the clinical trials registry A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis, but the following is a picture of the study population they used and the outcomes they hoped to meet.

The ORATORIO study was designed with these measures as their benchmarks for success:
“Primary Outcome Measures:
  • Efficacy: Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks [ Time Frame: up to 5.5 years ]
Secondary Outcome Measures:
  • Time to sustained disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks [ Time Frame: up to 5.5 years ]
  • Change in timed 25-foot walk [ Time Frame: from baseline to Week 120 ]
  • Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain [ Time Frame: from baseline to Week 180 ]
  • Safety and tolerability: Incidence of adverse events [ Time Frame: up to 5.5 years ]
Inclusion Criteria:
  • Adult patients, 18-55 years of age
  • Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
  • Expanded Disability Status Scale (EDSS) 3 to 6.5 points
  • Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose.”1

According to the official release from Genentech:
“The ORATORIO study met its primary endpoint, showing treatment with ocrelizumab significantly reduced the risk of progression of clinical disability sustained for at least 12 weeks by 24 percent compared with placebo, as measured by the EDSS (p=0.0321). Additionally, ocrelizumab was superior to placebo in significantly reducing the risk of progression of clinical disability for at least 24 weeks by 25 percent (p=0.0365) and the time required to walk 25 feet (Timed 25-Foot Walk, or T25-FW) over 120 weeks by 29 percent (p=0.0404). Ocrelizumab decreased the volume of hyperintense T2 lesions by 3.4 percent over 120 weeks, compared to placebo which increased T2 volume by 7.4 percent (p<0.0001). Ocrelizumab reduced the rate of whole brain volume loss over 120 weeks by 17.5 percent compared to placebo (p=0.0206).”

Exclusive Interview on Primary Progressive MS ORATORIO trial results

Peter Chin, MD, is Principal Medical Director for Genentech-Roche Global Neuroscience Development, and integral to the design and study of Ocrelizumab in both the OPERA and ORATORIO trials for the use of this drug in treating multiple sclerosis. Dr. Chin has treated people with MS where he learned more about the impact of this disease and its various stages. He took time from the proceedings of the ECTRIMS 2015 Congress to answer my questions.

Q: When will the results of the study ORATORIO be made available through formal papers so we might see all the results of this study?

CLICK HERE to see this answer as well as more questions and answers on the primary topic of this publication

Our thanks to Laura Kolaczkowski for sharing this information

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