- Source : Business Wire
- Date : 2021-10-13
- Event type : Phase 3
- Companies : Roche
New Data Up to 8-Years for Genentech's Ocrevus (Ocrelizumab) Show Early and Ongoing Treatment Significantly Reduced Risk of Requiring a Walking Aid in Relapsing Multiple Sclerosis and Disability Progression in Primary Progressive Multiple Sclerosis
– 35% reduction in risk of needing a walking aid in relapsing multiple sclerosis (RMS) after 7.5 years vs. initiation 2 years later in Phase III open-label extension (OLE) –
– 29% reduction in 48-week confirmed disability progression in primary progressive MS (PPMS) after 8 years vs. initiation after double-blind period in Phase III OLE –
– New 8-year safety data show consistent benefit-risk profile across all Ocrevus clinical trials –
– Shorter 2-hour infusion of Ocrevus was equally well-tolerated in Black, African-American, Hispanic and Latino populations compared with overall study populations across three studies –
– Genentech and research partners will be presenting late-breaking data on COVID-19 in treated patients –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data that reinforce the benefit of early initiation and ongoing treatment of Ocrevus® (ocrelizumab) on disability progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS), as well as safety outcomes for an analysis of a shorter two-hour infusion in minority populations. Ocrevus data from all clinical trials consistently show a favorable benefit-risk profile over eight years. Genentech and research partners will also present four late-breaking abstracts to share the latest data regarding COVID-19 and vaccine response in patients treated with Ocrevus. These data are being presented virtually at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
“Many neurologists have had first-hand experience with Ocrevus over eight years in clinical trials and witnessed the consistently favorable efficacy and safety outcomes in RMS and PPMS, especially the reductions in progression to disability when given early in the disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Additionally, the new safety analysis of the shorter two-hour Ocrevus infusion is encouraging particularly for groups that are often underrepresented in clinical trials. We continue our commitment to diversity and health equity in clinical trial participation and access to treatment.”
Phase III OPERA I and OPERA II open-label extension (OLE): Sustained reduction in disability progression and low relapse rates in RMS
Long-term Ocrevus treatment continues to demonstrate sustained reduction in disability progression and suppression of disease activity in people with RMS. Earlier intervention with Ocrevus resulted in a 35% reduction in the risk of patients with RMS needing a walking aid over 7.5 years compared with patients who switched from interferon beta-1a to Ocrevus after the 96-week double-blind period (5.2% vs. 7.0%, respectively; 95% CI: 0.65 [0.44–0.97]; p=0.034). The risk was measured by the length of time until a person reached a score on the Expanded Disability Status Scale of 6 or greater (EDSS≥6) that was sustained for at least 48 weeks in a post-hoc analysis. Data also showed that switching from interferon beta-1a to Ocrevus at the start of the OLE period was associated with a rapid and robust reduction in annualized relapse rate (ARR) that was maintained through the 5.5-year OLE period. ARR was 0.2 pre-switch, 0.1 after one year of Ocrevus treatment and 0.03 after 5.5 years of Ocrevus treatment in the OLE. Ocrevus continuers maintained a low ARR of 0.03 after 7.5 years of Ocrevus treatment.
Phase III ORATORIO OLE: Sustained reduction in overall and upper limb disability progression in PPMS
After eight years, outcomes continue to favor early and ongoing treatment with Ocrevus to slow disability progression in people with PPMS. Earlier intervention with Ocrevus resulted in a 29% reduction in 48-week confirmed disability progression (CDP) in patients with PPMS over eight years compared with patients who switched to Ocrevus from placebo after the double-blind period of at least 120 weeks (95% CI: 0.71 [0.57–0.87]; p=0.001). A 24% (95% CI: 0.76 [0.62–0.92]; p=0.005) reduced risk of recurrent 48-week CDP (re-baselining EDSS after onset of CDP event) was seen in patients who were continuously treated with Ocrevus compared with those who switched from placebo. Many people with PPMS eventually transition into a wheelchair; therefore, maintaining the ability to use their hands and arms is important for these patients. Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was also reduced in patients who were continuously treated with Ocrevus compared with those who switched from placebo (95% CI: 0.66 [0.50–0.86] respectively; p=0.002).
Ocrevus long-term safety data consistent over 8 years
New safety data as of November 2020 will be presented, representing 5,688 patients with RMS and PPMS and 21,675 patient-years of exposure to Ocrevus, across all Ocrevus clinical trials. These findings further demonstrate the consistently favorable benefit-risk profile of Ocrevus over eight years.
Three shorter infusion studies: subgroup analysis in minority populations
When treated with a shorter two-hour Ocrevus infusion, the rate and severity of infusion-related reactions in Black, African-American, Hispanic and Latino populations were similar to those reported in the overall patient population in a subgroup analysis of three studies (SaROD, CHORDS and ENSEMBLE PLUS). These patient populations may experience greater disease severity and faster progression, yet are vastly underrepresented in most clinical trials. A shorter infusion time may help reduce the burden on these patient populations and increase their access to treatment.
Late-breaking abstracts: COVID-19 in patients treated with Ocrevus
Patient safety is Genentech's highest priority and we are closely monitoring the evolving COVID-19 situation. We are committed to working closely with the community to better understand the impact of COVID-19 on people who are treated with Ocrevus, and will continue to share new insights with the MS community as they emerge.
Four late-breaking abstracts on COVID-19 in patients treated with Ocrevus, including vaccination response, will be presented by Genentech and research partners.
With rapidly growing real-world experience and more than 200,000 people treated globally, Ocrevus is the first and only therapy approved for RMS (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. At Genentech, we are constantly striving to optimize the care for people with MS and a shorter two-hour Ocrevus infusion time, dosed twice yearly (six-monthly), is now approved for eligible people with RMS or PPMS in the U.S. and European Union (EU).
Ocrevus is approved in 97 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland, the United Kingdom and the EU.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects nearly one million people in the United States. 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, 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.
People with 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 aren't apparent or don't appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, both in terms of their physical, mental and financial health. An important goal of treating MS is to slow the progression of disability as early as possible.
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% 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% of people with MS are diagnosed with the primary progressive form of the disease. Until the U.S. Food and Drug Administration (FDA) approval of Ocrevus, there had been no FDA-approved treatments for PPMS.
About Ocrevus® (ocrelizumab)
Ocrevus is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. 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.
Indications and Important Safety Information
What is Ocrevus?
Ocrevus is a prescription medicine used to treat:
- Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
- Primary progressive MS, in adults.
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:
- Infusion reactions: Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
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