Sept. 11, 2020 05:00 UTC

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data that show Ocrevus (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT). Subgroup analysis from the two-year open-label Phase IIIb CASTING study also demonstrates that patients benefit across a wide range of disease related and demographic subgroups, regardless of prior treatment background. Findings will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

For a wide range of people with MS who experienced a suboptimal response to prior treatment, we continue to see evidence that Ocrevus provides significant benefit in slowing disease progression, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. New real-world Ocrevus data show high persistence and adherence to the only B-cell therapy with a twice-yearly dosing schedule, which we know can be very important to both people with MS and their physicians.

Phase IIIb open-label CASTING study

Approximately 75% of RRMS patients (492/658) had no evidence of disease activity (NEDA; brain lesions, relapses and worsening of disability) two years after switching to twice-yearly Ocrevus treatment (with prespecified MRI re-baselining at 8 weeks) in the primary analysis of the CASTING study. Patients enrolled in the study had prior suboptimal response to at least six months of treatment with up to two DMTs. The analysis also showed the proportion of patients achieving NEDA remained consistently high across all measured patient subgroups, including baseline MRI activity, relapse activity, disability level, age and the number of prior DMTs. Further, 78% of patients treated with only one prior DMT compared with 70% of patients treated with two prior DMTs achieved NEDA.

Additionally, patients treated with Ocrevus experienced an improvement in the majority of symptoms measured by SymptoMScreen after two years. SymptoMScreen is a patient-reported outcome tool to assess symptom severity across twelve domains. The most pronounced significant improvements (p<0.001) were seen in sensory symptoms, fatigue and vision, which are important for daily living.

CONFIDENCE real-world safety study

A 97% treatment persistence for Ocrevus patients at 18 months, and strong adherence to infusions every six months, was seen in an interim analysis of more than 1,600 patients in the ongoing German CONFIDENCE study. Separate data from a U.S. commercial claims database that support high persistence and sustained adherence to Ocrevus treatment will also be presented.

Ocrevus longer-term safety data

New safety data as of January 2020 will be presented, representing 5,680 patients with RMS and PPMS and 18,218 patient-years of exposure to Ocrevus, across all Ocrevus clinical trials. These findings further demonstrate the consistently favorable benefit:risk profile of Ocrevus over seven years.

With rapidly growing real-world experience and more than 170,000 people treated globally, Ocrevus has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS [RRMS] and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and primary progressive MS (PPMS). Ocrevus is approved in 92 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects nearly one million people in the United States, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.

Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85 percent of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15 percent of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus, there had been no FDA approved treatments for PPMS.

People with all forms of MS experience disease activity inflammation in the nervous system and permanent loss of nerve cells in the brain even when their clinical symptoms arent apparent or dont appear to be getting worse. An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a persons disability progresses. Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.

About Ocrevus(ocrelizumab)

Ocrevus is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS) and PPMS, with dosing every six months. Ocrevus is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.

Ocrevus is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

Important Safety Information

What is Ocrevus?

Ocrevus is a prescription medicine used to treat:

It is not known if Ocrevus is safe or effective in children.

Who should not receive Ocrevus?

Do not receive Ocrevus if you have an active hepatitis B virus (HBV) infection.

Do not receive Ocrevus if you have had a life threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.

What is the most important information I should know about Ocrevus?

Ocrevus can cause serious side effects, including:

These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.

If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Ocrevus?

Ocrevus may cause serious side effects, including:

Most common side effects include infusion reactions and infections.

These are not all the possible side effects of Ocrevus.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For more information, go to http://www.Ocrevus.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimers disease, Huntingtons disease, Parkinsons disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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New Data Further Reinforce Genentech's Ocrevus (ocrelizumab) as a Highly Effective Treatment for People With Multiple Sclerosis - BioSpace