Wednesday, Jul 12, 2023
Phase III OCARINA II trial met primary and secondary endpoints
Ocrevus 10-minute injection has the potential to further improve the treatment experience and expand Ocrevus® usage in MS centers with IV capacity limitations or without IV infrastructure
Ocrevus remains the first and only therapy approved for both RMS and PPMS, and more than 300,000 people have been treated globally
South San Francisco, CA -- July 12, 2023 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III OCARINA II trial evaluating Ocrevus® (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of MS or primary progressive MS (RMS or PPMS). Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks. Ocrevus subcutaneous injection was also comparable with Ocrevus IV in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks. The safety profile of Ocrevus subcutaneous injection was consistent with that of Ocrevus IV.
The Ocrevus 10-minute injection is designed to be administered without the need for IV infrastructure so it has the potential to expand the usage of Ocrevus in MS centers without IV infrastructure or those with IV capacity limitations. It also retains the twice-yearly dosing regimen of Ocrevus IV that has shown high persistence and adherence since becoming a standard of care MS treatment.1 This provides an additional delivery option so that the administration of Ocrevus can be matched to the individual needs of patients and healthcare professionals.
“These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and healthcare resources,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “This new subcutaneous injection will allow Ocrevus to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’
Detailed results from the trial will be presented at an upcoming medical meeting and submitted to health authorities around the world. Roche is committed to advancing innovative clinical research programs to broaden the scientific understanding of MS, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with the disease.
About the OCARINA II study
OCARINA II is a Phase III, global, multicentre, randomized study evaluating the pharmacokinetics, safety and radiological and clinical effects of the subcutaneous formulation of Ocrevus compared with Ocrevus intravenous (IV) infusion in 236 patients with relapsing MS (RMS) or primary progressive MS (PPMS). The primary endpoint is non-inferiority in serum area under the curve (AUC) from day 1 to 12 weeks after subcutaneous injection compared to IV infusion. Secondary endpoints include maximum serum concentration (Cmax) of Ocrevus, the total number of active, gadolinium-enhancing T1 lesions at 8 and 12 weeks, and new or enlarging T2 lesions at 12 and 24 weeks, as well as safety and immunogenicity outcomes. Exploratory endpoints include patient-reported outcomes.
About the subcutaneous formulation of Ocrevus (ocrelizumab)
The investigational subcutaneous formulation combines Ocrevus with Halozyme Therapeutics’ Enhanze® drug delivery technology.
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.
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for large molecules like Ocrevus to enter, and enables the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream.
Ocrevus IV is the first and only therapy approved for the treatment of adults with either RMS (including relapsing-remitting MS [RRMS] and active secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS]) and PPMS. Ocrevus IV 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.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. 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 – from 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, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression 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 RRMS, CIS and SPMS with clinical or MRI activity. 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 FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.
Indications and 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 https://www.Ocrevus.com or call 1-844-627-3887.
About Genentech in Neuroscience
Neuroscience is a major focus of research and development at Genentech. 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 MS, SMA, NMOSD, Alzheimer’s, Huntington’s, Parkinson’s, Acute ischemic stroke, Duchenne muscular dystrophy and Angelman syndrome. 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.
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.
1Engmann NJ, Sheinson D, Bawa K, Ng CD, Pardo G. Persistence and adherence to ocrelizumab compared with other disease-modifying therapies for multiple sclerosis in U.S. commercial claims data. J Manag Care Spec Pharm. 2021;27(5):639-649.