Thursday, Mar 24, 2022
First data showing Ocrevus (ocrelizumab) treatment effect on disability progression in non-active secondary progressive multiple sclerosis and further data in primary progressive multiple sclerosis will be presented
Evrysdi (risdiplam) data continue to demonstrate long-term efficacy and safety in a broad population of people with spinal muscular atrophy
Longer-term efficacy and safety for Enspryng (satralizumab-mwge) in neuromyelitis optica spectrum disorder reinforce previously seen results
Additional data across neurological disorders, including Alzheimer’s disease, help advance the scientific understanding of these conditions and the potential impact of early treatment
South San Francisco, CA -- March 24, 2022 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data for its approved and investigational medicines across neurological disorders will be presented at the 74th American Academy of Neurology (AAN) Annual Meeting being held April 2-7 in Seattle and virtually April 24-26, 2022. These data include twenty two abstracts highlighting Genentech’s expansive neuroscience portfolio across multiple therapeutic areas, including Ocrevus® (ocrelizumab) in relapsing, secondary and primary progressive multiple sclerosis (RMS, SPMS and PPMS), Evrysdi™ (risdiplam) in spinal muscular atrophy (SMA), Enspryng™ (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD), along with data from investigational programs in Alzheimer’s disease (AD).
“The longer-term efficacy and safety data for Ocrevus, Evrysdi and Enspryng, as well as findings from diverse and underrepresented populations, demonstrate the significant impact of our expanding neuroscience portfolio,” said Levi Garraway, M.D., Ph.D. chief medical officer and head of Global Product Development. “We remain committed to advancing the science and improving the lives of people living with neurological conditions.”
Multiple Sclerosis (MS)
Genentech will present 11 abstracts on MS and Ocrevus at AAN. New data from the one-year interim analysis of CONSONANCE, a first-of-its-kind open-label Phase III trial, will show the treatment effect of Ocrevus in the complete spectrum of progressive MS – SPMS and PPMS – with novel composite disability endpoints.
Additionally, an analysis of a U.S. claims database will highlight treatment disparities between Black and Hispanic/Latino-American patients and non-Hispanic white patients in the two years after diagnosis. Addressing health inequity and inclusion in research is central to Genentech’s mission to improve patient health outcomes. The insights from the data presented at AAN reinforce the importance of Genentech’s CHIMES trial evaluating Ocrevus in Black and Hispanic patients with MS, which is now fully enrolled across sites in the U.S. and Kenya.
Spinal Muscular Atrophy (SMA)
Genentech will present encore data from the clinical development program for Evrysdi, including 3-year data from SUNFISH Part 1 and 2, highlighting the long-term efficacy and safety of Evrysdi in people aged 2-25 years with Type 2 or Type 3 SMA. In addition, updated interim efficacy data from the RAINBOWFISH study in presymptomatic infants with SMA will be presented. The clinical development program represents the broad real-world spectrum of people living with SMA from newborn babies to people aged 60 years old.
Genentech will also share the design of the new MANATEE trial, a multicenter, randomized, placebo-controlled, double-blind trial studying GYM329, an investigational anti-myostatin, in combination with Evrysdi.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Genentech will present encore long-term efficacy and safety data from the Enspryng SAkuraSky and SAkuraStar studies. These data reinforce the previously observed efficacy and safety of Enspryng, the first and only approved treatment designed to target and inhibit the IL-6 receptor activity and that can be administered subcutaneously every four weeks at home after training from a healthcare provider.
To increase the scientific understanding of NMOSD and improve care for all people living with the condition, Genentech has initiated SAkuraBONSAI, a multicenter, Phase IIIb, international study evaluating Enspryng treatment for people with AQP4-IgG seropositive NMOSD who are treatment naïve, or where prior rituximab (or biosimilar) treatment has failed*; SAkuraBONSAI will further evaluate disease activity and progression using comprehensive imaging, biomarker and clinical assessment.
*It is important to note, rituximab (or any biosimilar) is not approved by regulatory authorities for the treatment of NMOSD.
Alzheimer’s Disease (AD)
Genentech will present updates from its AD clinical program, including baseline characteristics from the Phase III GRADUATE studies in patients with early AD.
In addition, the design of the post-GRADUATE open label rollover study evaluating the long-term safety, tolerability and efficacy of gantenerumab in patients from the GRADUATE 1 and 2 studies will be presented.
For more than two decades, Genentech has been studying and developing gantenerumab, a late-stage investigational subcutaneously-administered monoclonal antibody, for the treatment of AD. Data from the pivotal GRADUATE trials are expected in the fourth quarter of 2022. Gantenerumab is also being evaluated in the Phase III SKYLINE prevention trial to better understand the potential of the investigational therapy to slow disease progression in people with the earliest biological signs of AD.
The full range of data from Genentech’s clinical development program in neuroscience being presented at 2022 AAN include:
Medicine and/or Therapeutic Area |
Abstract Title |
Presentation Number (type), Presentation Date, Time
|
Ocrevus (ocrelizumab) for Multiple Sclerosis |
Demographics and Baseline Disease Characteristics of Black and Hispanic Patients with Multiple Sclerosis Enrolled in the CHIMES Trial |
P4.4-005 (poster) Sunday, April 3, 8:00 – 9:00 a.m. PT |
Efficacy and Safety of Ocrelizumab in Patients with RRMS with Suboptimal Response to Prior Disease-Modifying Therapies: 3-Year Data from CASTING and LIBERTO 1-Year Interim Results |
P5.4-003 (poster) Sunday, April 3, 11:45 a.m. –12:45 p.m. PT | |
Long-Term Suppression of MRI Disease Activity and Reduction of Global/Regional Volume Loss: Results from OPERA I/II and ORATORIO Open-Label Extension |
P6.4-002 (poster) Sunday, April 3, 5:30 – 6:30 p.m. PT | |
Repeated Confirmed Disability Progressions Analyses of the OPERA and ORATORIO Studies and their Open-Label Extensions |
P7.4-002 (poster) Monday, April 4, 8:00 – 9:00 a.m. PT | |
Evaluating the Impact of Administration of Ocrelizumab via Home Infusion on Safety and Patient-Reported Outcomes |
P16.4-005 (poster) Thursday, April 7, 8:00 – 9:00 a.m. PT | |
Evaluation of NEDA as a Predictor of Disease Progression in Patients with RMS and PPMS Treated with Ocrelizumab: Post-Hoc Analyses from the OPERA I/OPERA II and ORATORIO Trials |
P16.4-007 (poster) Thursday, April 7, 8:00 – 9:00 a.m. PT | |
Treatment Patterns Among Newly Diagnosed Patients with Multiple Sclerosis by Race and Ethnicity |
S40.001 (presentation) Thursday, April 7, 3:30 p.m. PT | |
A Multicenter, Open-Label, Single-Arm, Phase 3b Study (CONSONANCE) to Assess the Effectiveness and Safety of Ocrelizumab in Patients with Primary and Secondary Progressive Multiple Sclerosis: Year 1 Interim Analysis |
Virtual Session April 24-26 | |
A Multicenter, Open-Label, Single-Arm, Phase 3b Study (CONSONANCE) to Assess Efficacy of Ocrelizumab in Patients with Primary and Secondary Progressive Multiple Sclerosis: Year 1 Interim Analysis of Cognition Outcomes |
Virtual Session April 24-26 | |
Humoral and Cellular Responses to SARS-CoV-2 Vaccines in MS Patients on Ocrelizumab and other Disease-Modifying Therapies: A Prospective Study from NYU Multiple Sclerosis Care Center |
Virtual Session April 24-26 | |
Gantenerumab for Alzheimer’s Disease |
Postgraduate Open-Label Rollover Study: Evaluation of Subcutaneous Gantenerumab Long-Term Safety, Tolerability, and Efficacy in Participants with Alzheimer’s Disease |
P6.3-002 (poster) Sunday, April 3, 5:30 – 6:30 p.m. PT |
Baseline Characteristics of the GRADUATE Studies: Phase III Randomized, Placebo-Controlled Studies Investigating Subcutaneous Gantenerumab in Participants with Early Alzheimer’s Disease |
P16.3-005 (poster) Thursday, April 7, 8:00 – 9:00 a.m. PT | |
Alzheimer’s Disease |
Quantification of Cognitive Impairments in Preclinical and Early Alzheimer’s Disease: A Proof of Concept Study to Investigate the Feasibility, Adherence and Preliminary Clinical Validity of Remote Smartphone Based Self-Assessments of Cognition, Function and Behavior |
P14.3-002 (poster) Wednesday, April 6, 11:45 a.m. – 12:45 p.m. PT |
Evrysdi (risdiplam) for Spinal Muscular Atrophy |
JEWELFISH: Safety, Pharmacodynamic and Exploratory Efficacy Data in Non-Naïve Patients with Spinal Muscular Atrophy (SMA) Receiving Treatment with Risdiplam |
P15.5-004 (poster) Wednesday, April 6, 5:30 – 6:30 p.m. PT |
MANATEE: A Study of RO7204239 in Combination with Risdiplam Treatment in Pediatric Patients with SMA |
P16.5-002 (poster) Thursday, April 7, 8:00 – 9:00 a.m. PT | |
RAINBOWFISH: Preliminary Efficacy and Safety Data in Risdiplam-Treated Infants with Presymptomatic SMA |
P17.5-003 (poster) Thursday, April 7, 11:45 a.m. – 12:45 p.m. PT | |
SUNFISH: 3-year Efficacy and Safety of Risdiplam in Types 2 and 3 SMA |
S39.003 (presentation) Thursday, April 7, 3:54 p.m. PT | |
FIREFISH Parts 1 and 2: 24-month Safety and Efficacy of Risdiplam in Type1 SMA |
S39.005 (presentation) Thursday, April 7, 4:18 p.m. PT | |
Pooled Safety Data from the Risdiplam Clinical Trial Development Program |
P18.5-001 (poster) Thursday, April 7, 5:30 – 6:30 p.m. PT | |
Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder |
Long-Term Efficacy of Satralizumab in Aquaporin-4-IgG-seropositive Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Open-Label Extension Periods of SAkurasky and SAkurastar |
S25.009 (presentation) Tuesday, April 5, 5:06 p.m. PT |
Long-Term Safety of Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Phase 3 SAkurasky and SAkurastar Studies |
S25.010 (presentation) Tuesday, April 5, 5:18 p.m. PT | |
SAkuraBONSAI: A Prospective, Open-Label Study of Satralizumab Investigating Novel Imaging, Biomarker, and Clinical Outcomes in Patients with Aquaporing-4-IgG- seropositive (AQP4-IgG+) NMOSD |
P15.1-002 (poster) Wednesday, April 6, 5:30 – 6:30 p.m. PT |
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:
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 EVRYSDI™ (risdiplam)
Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.
Evrysdi is designed to treat SMA by increasing and sustaining the production of SMN protein in the central nervous system (CNS) and peripheral tissues as demonstrated in animal models. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.
What is Evrysdi?
Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.
It is not known if Evrysdi is safe and effective in children under 2 months of age.
Important Safety Information
These are not all of the possible side effects of Evrysdi. For more information on the risk and benefits profile of Evrysdi, patients should ask their healthcare provider or pharmacist.
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 ENSPRYNGTM (satralizumab)
Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD disease processes, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology. When compared to conventional antibodies, Enspryng’s recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.
Positive Phase III results for Enspryng, as both monotherapy and in combination with baseline immunosuppressive 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 currently approved in 58 countries, including the United States, Canada, Japan, South Korea and the European Union.
Enspryng has been designated as an orphan drug in the United States, Europe, Japan and Russia. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018, which is given to treatments that may demonstrate substantial improvement over other available options.
About ENSPRYNGTM (satralizumab-mwge)
Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD disease processes, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology. When compared to conventional antibodies, Enspryng’s recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.
Positive Phase III results for Enspryng, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD who are AQP4-IgG seropositive. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.
Enspryng is currently approved in 63 countries, including the United States, Canada, Japan, South Korea and the European Union.
Enspryng has been designated as an orphan drug in the United States, Europe, Japan and Russia. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018, which is given to treatments that may demonstrate substantial improvement over other available options.
Indications and 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, Alzheimer’s disease, Parkinson’s disease 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.