Wednesday, Sep 2, 2020
New data further reinforce Ocrevus (ocrelizumab) as a highly effective treatment option offering a favorable and consistent benefit:risk profile, with high treatment persistence and adherence
Initiation of Phase IIIb Ocrevus higher dose clinical trial program and Phase IV study evaluating Ocrevus in minority populations
Initiation of Phase III clinical trial program for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS
New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with Enspryng (satralizumab-mwge), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD)
South San Francisco, CA -- September 2, 2020 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) data will be presented at MSVirtual2020, the 8th Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) - European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting from September 11 – 13, 2020.
“While conditions of the nervous system are some of the most complex to understand and treat, we are committed to following the science to reduce relapses in NMOSD and slow and eventually stop disease progression in MS,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “From the success of our first-in-class B cell MS therapy Ocrevus, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of Enspryng.”
Multiple Sclerosis (MS)
New analyses from the two-year open-label Phase IIIb CASTING study will show patients with relapsing-remitting MS (RRMS) who experienced a prior suboptimal response to one or more disease-modifying therapies (DMTs) achieved a high rate of no evidence of disease activity (NEDA) after switching to Ocrevus. Other data to be presented will show high treatment persistence and strong adherence for patients treated with Ocrevus compared to other DMTs in real-world settings. Additionally, new longer-term safety data will reinforce the consistently favorable benefit:risk profile of Ocrevus.
We are exploring potential optimization of Ocrevus, our first-in-class B cell therapy, in a large Phase IIIb clinical trial program to evaluate the impact of higher dose Ocrevus on reducing disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). This decision was based on a post-hoc analyses from the pivotal RMS and PPMS studies presented at the American Academy of Neurology Annual Meeting 2019, which showed higher Ocrevus exposure was associated with lower B-cell levels and with less disability progression, without any associated impact on safety.
Genentech is also deeply committed to addressing barriers to clinical trial participation and advancing inclusive research. The study design of the recently initiated CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial, an open-label, multi-center Phase IV study evaluating disease activity and neurological biomarkers in African-American and Hispanic- and Latinx-American people with RMS treated with Ocrevus, will be presented.
Genentech's commitment to potentially slow or stop disease progression continues with the Phase III clinical trial program initiation of fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor in RMS and PPMS. Fenebrutinib is designed to be a highly selective small molecule and is the only reversible (non-covalent) BTK inhibitor currently in Phase III development in MS.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
New data show Enspryng lowered relapse severity in people with NMOSD in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies also showed Enspryng significantly reduced risk of relapse, further reinforcing the findings from the double-blind period. Preventing relapses, the most severe of which cause cumulative, irreversible neurological damage and disability, is the primary goal for NMOSD disease management.
On August 14, Enspryng was approved by the U.S. Food and Drug Administration (FDA) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive NMOSD, a rare disabling neurological disorder often mistaken for MS. Enspryng can be self-administered every four weeks by a person living with NMOSD or a caregiver, after an initial loading dose and following training by a healthcare provider.
Until recently, people living with NMOSD did not have medicines specifically tested and designed to treat the condition. Many people with NMOSD remain misdiagnosed and untreated.
New data from the double-blind and OLE trials continue to build on one of the largest pivotal clinical trial programs undertaken for this rare neurological disease, further demonstrating Enspryng’s sustained efficacy and favorable safety profile in adults with NMOSD.
Follow Genentech on Twitter via @Genentech and keep up to date with MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting news and updates by using the hashtag #MSVIRTUAL2020.
A full list of Genentech presentations can be found at: https://cslide.ctimeetingtech.com/msdc2020/attendee/confcal/session
Presentations at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting include:
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Medicine |
Abstract Title |
Presentation Number (type) Presentation Date Time |
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Ocrevus (ocrelizumab) for Multiple Sclerosis |
Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis |
#P0389 (on-demand e-poster)
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Rationale and Design of Two Phase IIIb Studies of Ocrelizumab at Higher Than the Approved Dose in Patients with RMS and with PPMS |
#P0230 (on-demand e-poster)
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Ocrelizumab Phase IIIb Efficacy from CASTING: 2-Year NEDA (MRI Re-baselined) Subgroup Rates in RRMS Patients with a Suboptimal Response to Prior DMTs |
#P0219 (on-demand e-poster)
| |
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Improvements in Patient-reported SymptoMScreen Scores Among Ocrelizumab-treated Patients with RRMS: 2-year Results from the CASTING Clinical Trial |
#P1039 (on-demand e-poster)
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Ocrelizumab Treatment in Patients with RRMS Who Had a Suboptimal Response on One or More Prior Disease-modifying Therapies: CHORDS 2-year Results |
#P0221 (on-demand e-poster)
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Ocrelizumab Phase IIIb Efficacy: 1-year NEDA Rates (with MRI Re-baselining) from the ENSEMBLE Study in Early-stage Relapsing-remitting MS Patients |
#P0220 (on-demand e-poster)
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Change in Serum Neurofilament Light Chain Levels: ENSEMBLE 1-year Interim Results |
#P0037 (on-demand e-poster)
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Shorter Infusion Time of Ocrelizumab: Results from the ENSEMBLE PLUS Study in Patients with Relapsing-remitting Multiple Sclerosis |
#P0392 (on-demand e-poster)
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FlywheelMS: The Prevalence of Multiple Sclerosis Subtypes in Digitized Health Records |
#P0875 (on-demand e-poster)
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Treating Minority Patients with Multiple Sclerosis: Development of the CHIMES Trial |
#P0242 (on-demand e-poster)
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Characteristics and Patient Reported Outcomes of Patients Initiating Ocrelizumab in the NARCOMS Registry from 2017 to 2019 |
#P1009 (on-demand e-poster)
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Ocrelizumab Treatment Induces a Sustained Blood NfL Reduction in Patients with PPMS and RMS |
#P0125 (on-demand e-poster)
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Modulation of Cerebrospinal Fluid Immunoglobulins by Ocrelizumab Treatment |
#P0110 (on-demand e-poster)
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Long-term Reduction of Relapse Rate and 48-week Confirmed Disability Progression After 6.5 Years of Ocrelizumab Treatment in Patients with RMS |
#P0216 (on-demand e-poster)
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Sustained Reduction in 48-week Confirmed Disability Progression in Patients with Ocrelizumab in the ORATORIO OLE: 7-year Follow-up |
#P0237 (on-demand e-poster)
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Ocrelizumab Reduces Thalamic Volume Loss and Clinical Progression in PPMS and RMS Independent of Baseline NfL and Other Measures of Disease Severity |
#P0123 (on-demand e-poster)
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Treatment Persistence and Adherence to Ocrelizumab in the Real-world Setting- an Ad-hoc Analysis of the CONFIDENCE Study |
#P1063 (on-demand e-poster)
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Persistence and Adherence to Ocrelizumab Compared with Other Disease-modifying Therapies for Multiple Sclerosis for up to 18 Months in the US |
#P0897 (on-demand e-poster)
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Characteristics of Patients Initiating Ocrelizumab vs Other Disease-modifying Therapies in a US National Multiple Sclerosis Registry |
#P0845 (on-demand e-poster)
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Collecting Real-world MRI Data in Patients with MS: Preliminary Results from FlywheelMS |
#P0856 (on-demand e-poster)
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Pregnancy Outcomes in Patients Treated with Ocrelizumab |
#P1132 (on-demand e-poster)
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Reduced Thalamic Atrophy in Patients Initiating Earlier versus Delayed Ocrelizumab Therapy: Results from the OLE of OPERA I/II and ORATORIO |
#FC03.05 (oral presentation)
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Fenebrutinib for Multiple Sclerosis |
Examination of Fenebrutinib, a Highly Selective BTKi, on Disease Progression of Multiple Sclerosis |
#P0211 (on-demand e-poster)
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Fenebrutinib, a Noncovalent, Highly Selective, Long Residence Time Investigational BTK Inhibitor for the Treatment of MS |
#P0338 (on-demand e-poster)
| |
|
Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder |
Satralizumab in First Incident Treatment-Naive AQP4-IgG Seropositive NMOSD Patients Enrolled to SAkuraStar: A Case Series |
#P0754 (on-demand e-poster)
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Safety of Satralizumab Based on Pooled Data from Phase 3 Studies in Patients with Neuromyelitis Optica Spectrum Disorder |
#P0753 (on-demand e-poster)
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Infection Rates with Satralizumab in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Phase 3 SAkura Studies |
#P0721 (on-demand e-poster)
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Efficacy of Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from Open-Label Extension Periods of SAkuraSky and SAkuraStar |
#P0711 (on-demand e-poster)
| |
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Estimating the Cost of Illness for Patients with Neuromyelitis Optica Spectrum Disorder from US Commercial Claims |
#P0712 (on-demand e-poster)
| |
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Psychometric Validation of the Expanded Disability Status Scale in Neuromyelitis Optica Spectrum Disorder |
#P1046 (on-demand e-poster)
| |
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Autoimmune Comorbidity Increases Healthcare Cost Burden in Patients with NMOSD in the United States: A Retrospective Commercial Claims Analysis |
#P0689 (on-demand e-poster)
| |
|
Cost of Illness for Patients with NMOSD and Nonautoimmune Disease Estimated from Claims Databases in the United States |
#P0705 (on-demand e-poster)
| |
|
Burden of Autoimmune Comorbidity in Patients with NMOSD in the United States Revealed by Retrospective Commercial Claims Analysis |
#P0694 (on-demand e-poster)
| |
|
Treatment Patterns in Patients with Neuromyelitis Optica Spectrum Disorder |
#P0759 (on-demand e-poster)
| |
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Effect of Satralizumab on Relapse Severity in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Phase III SAkura Studies |
#FC01.03 (oral presentation)
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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 Enspryng™ (satralizumab-mwge)
Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets IL-6 receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology, which compared to conventional technology, allows for longer duration of the antibody and subcutaneous dosing every four weeks.
Positive Phase III results for Enspryng, as both monotherapy and used concurrently with baseline immunosuppressant therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.
Enspryng is approved in the U.S., Canada, Japan and Switzerland. Applications are under review with numerous regulators, including in the EU and China.
Enspryng has been designated as an orphan drug in the U.S., Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.
What is Enspryng?
Enspryng is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.
It is not known if Enspryng is safe and effective in children.
Important Safety Information
Patients should not take Enspryng if they:
Enspryng may cause serious side effects including:
Before taking Enspryng, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take , including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of Enspryng include:
For more information about the risk and benefit profile of Enspryng, patients should ask their healthcare provider.
Patients may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at 1-888-835-2555.
Please see the full Prescribing Information for additional Important Safety Information.
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, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s 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.