MS Speaks

Multiple Sclerosis => TREATMENTS => OCREVUS (ocrelizumab) => Topic started by: agate on September 28, 2015, 03:43:26 pm

Title: (MSAA) Ocrelizumab shows positive results in treating PPMS
Post by: agate on September 28, 2015, 03:43:26 pm
From the MSAA newsletter, September 28, 2015:

Ocrelizumab Shows Positive Results in Treating PPMS

Parent company Genentech announced today that ocrelizumab, an investigational medicine for the long-term treatment of relapsing forms of MS, has also shown positive study results in their Phase III ORATORIO study with primary-progressive multiple sclerosis (PPMS). This is the first medication to show positive effects on disability with this form of the disease, which affects approximately 10 percent of the MS population.

To date, 13 disease-modifying therapies (DMTs) are approved for the long-term treatment of relapsing forms of MS, which exhibit the flare-ups and remissions often seen in MS. However, no treatments are available for individuals diagnosed with PPMS, whose MS steadily progresses without remissions.

According to Genentech, the Phase III ORATORIO study met its primary endpoint, showing that treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo, as measured by the Expanded Disability Status Scale (EDSS). They also state that overall, the incidence of adverse events associated with ocrelizumab was similar to placebo; the most common adverse events were mild-to-moderate infusion-related reactions. The incidence of serious adverse events associated with ocrelizumab, including serious infections, was also similar to placebo.

ORATORIO was a randomized, double-blind, and global multi-center trial that studied the effectiveness and safety of ocrelizumab in 732 people with PPMS. Every six months, two 300-mg infusions (for a total of 600 mgs) were given two weeks apart. Members of the treatment group were compared to a placebo group. The primary endpoint of this study was time to the onset of confirmed disability progression, defined as an increase in EDSS that is sustained for at least 12 weeks.

On July 1, 2015, MSAA posted the news item titled Ocrelizumab Shows Positive Results in Phase III Trials, which announced that ocrelizumab met both the primary and major secondary endpoints in the Phase III, OPERA I and OPERA II studies. These studies evaluated the effectiveness and safety of ocrelizumab in relapsing forms of MS. According to Genentech, when compared to Rebif, ocrelizumab showed "significant reductions" in: annualized relapse rate (ARR) over a two-year period; progression of clinical disability, as measured by the Expanded Disability Status Scale (EDSS); and number of lesions in the brain (areas of disease activity) as measured by MRI.

Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. Genentech notes that these are a specific type of immune cell thought to be a key contributor to myelin and axonal damage, which can result in disability in people with MS. Based on preclinical studies, ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

Genentech plans to submit data from all three of these studies to the United States Food and Drug Administration (FDA) in early 2016. If approved, this medication could potentially be used to treat not only relapsing forms of MS, but also primary-progressive MS, and would represent the first treatment available for this latter form of the disease.

MSAA Chief Medical Officer Dr. Jack Burks states, "This is very exciting news. Ocrelizumab is the first DMT with positive disability results. In addition, the safety data were similar to placebo controls. However, FDA approval will require intense scrutiny of these data. Effectiveness combined with safety is the magic formula, and we’ll see if the FDA agrees that ocrelizumab meets both requirements for approval in not only relapsing forms of MS, but in PPMS as well."


Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer
Title: Roche to pursue Ocrelizumab drug market authorization
Post by: agate on November 17, 2015, 08:51:10 pm
From Multiple Sclerosis News Today, November 16, 2015:

Roche to Pursue MS Ocrelizumab Drug Market Authorization

Data on PPMS and RMS groundbreaking therapy ocrelizumab will be submitted to global regulatory authorities
Patricia Silva, PhD

Roche recently provided an update on their late-stage pipeline products across several therap-eutic areas, including ocrelizumab for the treatment of multiple sclerosis. The data was disclosed on Nov. 5 at the Roche Pharma Day 2015 event in London, U.K.

Ocrelizumab was previously revealed to be the first investigational medicine to have a positive impact in two forms of multiple sclerosis, primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS). Ocrelizumab is a recombinant humanized monoclonal antibody against immune B cells that express CD20 proteins at their surface. These cells are thought to be a key contributor to the myelin and neuron damage that leads to motor function impairment, irreversible neurological disability, and paralysis in multiple sclerosis patients. Roche is planning to submit data on ocrelizumab to global regulatory authorities in early 2016 to obtain marketing authorization for the drug as a potential new therapy for RMS and a first approved treatment for PPMS.

Apart from the update on the company’s most advanced investigational therapeutics presented at the event, executives also briefed investors and analysts on Roche’s strategy, R&D productivity, management and new market opportunities. Roche’s strategy is to continue to focus on innovation and treatment advancement across a range of high medical need areas. The company plans to further explore the wealth of molecular data becoming available and use that information in drug discovery and development.

“Thanks to our diversified late-stage portfolio we are well positioned to maintain our leadership in oncology, expand further in the immunology and ophthalmology segments, and potentially offer new treatments to help improve the lives of people with multiple sclerosis and haemophilia,” said Daniel O’Day, COO of Roche’s Pharmaceuticals Division in a news release. “And we are looking to harness the vast increase in molecular information as the next important step in our efforts to develop even better, more personalized treatment solutions.”