New data reveals Roche’s OCREVUS is highly effective for RRMS

Swiss pharma giant Roche announced today new data that demonstrates 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 further revealed that patients benefit across a broad spectrum of disease-related and demographic subgroups, regardless of any previous treatment background. The fresh 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).

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development commented:

“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. 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.”

The Phase IIIb open-label CASTING study

According to the primary analysis of the CASTING study, approximately 75 per cent of RRMS patients (492 out of 658) had no evidence of disease activity (NEDA; brain lesions, relapses and worsening of disability) a couple of years after switching to twice-yearly OCREVUS treatment (with prespecified MRI re-baselining at 8 weeks). Patients enrolled in the study had prior suboptimal response to at least six months of treatment with up to two DMTs. The analysis also showcased 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. Moreover, 78 per cent of patients treated with only one prior DMT compared with 70 per cent of patients treated with two prior DMTs achieved NEDA.

In addition, patients treated with OCREVUS experienced an improvement in most of the symptoms assessed by SymptoMScreen after a couple of years. SymptoMScreen is a patient-reported outcome tool to measure symptom severity across twelve domains. The most pronounced significant improvements (p<0.001) were seen in sensory symptoms, fatigue and vision, which are very important for day to day living.

The ongoing CONFIDENCE real-world safety study

A 97 per cent treatment persistence for OCREVUS patients at 18 months, and strong adherence to infusions every 6 months, was observed 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 is also going to be presented.

OCREVUS longer-term safety data

Fresh safety data as of January this year, representing 5,680 patients with RMS and PPMS and 18,218 patient-years of exposure to OCREVUS, across all OCREVUS clinical trials, will also be presented. These results also show the consistently favourable benefit-risk profile of OCREVUS over 7 years.

With fast-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). Roche’s OCREVUS is approved in 92 countries across the EU, Switzerland, North America, South America, the Middle East, Eastern Europe, as well as in Australia.

About OCREVUS® (ocrelizumab) – the first and only treatment approved for both RMS & PPMS

OCREVUS is the very first and the only approved therapy for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS, in addition to CIS in the U.S.) and PPMS. The medication is a humanised 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 first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

Back in April this year Roche announced a post-hoc analysis demonstrating that OCREVUS can reduce the risk of needing walking aid by 49% in patients with RMS.

About multiple sclerosis (MS)

Multiple sclerosis (MS) is a chronic disease that affects nearly 1 million people in the United States and more than 2.3 million people across the globe. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, vision impairment and fatigue, 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.

Patients suffering from all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system and gradual worsening of disability – at the beginning of their disease even if their clinical symptoms are not apparent or do not appear to be deteriorating. Delays in diagnosis and treatment can have a negative effect on people with MS, in terms of their physical and mental health as well as their financial and emotional wellbeing. A major aim of MS treatment is to slow down and delay the progression of disability as early as possible.

The most common form of the disease is relapsing-remitting MS (RRMS) and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Around 85 per cent of people suffering from MS are initially diagnosed with RRMS. Most of the people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience gradually worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to have relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but commonly without distinct relapses or periods of remission. An estimated 15 per cent of people with MS are diagnosed with the primary progressive form of the disease. Until the approval of OCREVUS by the FDA, there had been no FDA approved treatments for PPMS.

About Roche’s R&D in Neuroscience

Roche is placing a major focus on research and development in neuroscience. The worldwide healthcare company is aiming to pursue groundbreaking science and to develop novel treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne’s muscular dystrophy and autism spectrum disorder. Together with its partners, Roche is committed to pushing the boundaries of scientific understanding and solving some of the most complex challenges in neuroscience today.

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