Business Wire | Oct 5, 2021 01:00AM EDT

Genentech to Present New Data on Ocrevus (ocrelizumab) in Multiple Sclerosis and Enspryng (satralizumab-mwge) in Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2021

Oct. 05, 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 05, 2021--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new Ocrevus(r) (ocrelizumab) and EnspryngTM (satralizumab-mwge) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 13 - 15, 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both Ocrevus and Enspryng, as well as our ongoing efforts to evaluate the impact of the COVID-19 pandemic for people living with MS. Additional data will show how a deeper scientific understanding of MS and NMOSD in diverse patient populations could help ensure access to treatment.

"The longer-term efficacy and safety data for both Ocrevus and Enspryng reinforce the impact of these treatments - by significantly slowing disease progression in MS and by preventing debilitating relapses in NMOSD, respectively," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We continue to see that early and ongoing treatment markedly improves outcomes, and we'll continue to use scientific and real-world insights to improve our understanding and ways to support people living with these neurological disorders."

Multiple sclerosis (MS)

Genentech will present 27 MS studies, including long-term data that show earlier treatment with Ocrevus continues to impact disability progression up to 8 years in people with primary progressive multiple sclerosis (PPMS) and up to 7.5 years in people with relapsing multiple sclerosis (RMS) in the Phase III open label extension (OLE) studies. Additionally, updated long-term safety analysis of all clinical trials in patients with RMS and PPMS will reinforce the consistently favorable benefit-risk profile of Ocrevus.

Genentech remains committed to addressing health disparities and we believe inclusive research can improve outcomes and derive insights that may address treatment barriers. A subgroup analysis of three studies (SaROD, CHORDS and ENSEMBLE PLUS) in Black, African-American, Hispanic and Latino populations treated with a 2-hour Ocrevus infusion will be presented.

Neuromyelitis optica spectrum disorder (NMOSD)

New longer-term results from the SAkuraStar and SAkuraSky OLE studies for Enspryng will show efficacy observed in the pivotal trials is sustained with high proportions of patients remaining free from relapse over four years of treatment. Similarly, safety data from the SAkuraStar and SAkuraSky OLE studies will show the favorable safety profile of Enspryng is sustained with longer-term treatment. Enspryng has been approved in 58 countries globally, including in the U.S. as the first and only subcutaneous treatment for adults with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD. Enspryng has also been approved for both adults and adolescents in the European Union, Japan, Canada and Switzerland.

Genentech is dedicated to increasing scientific understanding of NMOSD and improving care for all people living with the condition. The study design will be presented for SAkuraBONSAI, a prospective, open-label study of Enspryng to generate data to further the understanding of the disease activity and mechanism of action of Enspryng in patients living with AQP4-IgG seropositive NMOSD who are treatment nave or where prior rituximab (or biosimilar) treatment has failed. Other presentations will examine the development of new tools and techniques to identify patients with NMOSD and assess disability better.

Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2021 news and updates by using the hashtag #ECTRIMS2021.

PresentationMedicine and/or Number (type)Therapeutic Area Abstract Title Presentation Date Time

Presentations scheduled for Wednesday, October 13, 6:00 AM - 3:00 PM ET,unless indicated differently

#158 (Oral Sustained Reduction in 48-week Confirmed presentation) Disability Progression in Patients with Friday, PPMS Treated with Ocrelizumab in the October 15 ORATORIO OLE: 8-Year Follow-up 9:33 - 9:40 AM ET

Long-term Reduction of Relapse Rate and #P723 Confirmed Disability Progression After 7.5 (ePoster) Years of Ocrelizumab Treatment in Patients Thursday, with Relapsing Multiple Sclerosis in the October 14 OPERA OLE 6:00 AM - 3:00 PM ET

#P724 Safety of Ocrelizumab in Multiple (ePoster) Sclerosis: Updated Analysis in Patients Thursday, with Relapsing and Primary Progressive October 14 Multiple Sclerosis 6:00 AM - 3:00 PM ET

Infusion-related Reactions in Black/African #P690 American and Hispanic/Latino Patients (ePoster) Treated with Ocrelizumab Administered as a Shorter Infusion

#161 (Oral Real-world Experience With Ocrelizumab in presentation) Relapsing Multiple Sclerosis: Insights from Friday, The MSOCR-R Cohort, a MSBase Registry October 15 Sub-Study 9:19 - 9:26 AM ET

#029 (Oral Changes in Brain Metabolites Over 1 Year in presentation) Participants of the OBOE Trial for RMS and Wednesday, PPMS October 13 7:57 - 8:04 AM ET

#P407 Long-term Suppression of MRI Disease (ePoster) Activity and Reduction of Global/Regional Thursday, Volume Loss: Results from OPERA I/II and October 14 ORATORIO Open-label Extension 12:10 - 12:15 PM ETOcrevus (ocrelizumab)for Multiple Slowly Evolving Lesions Showed Less Myelin #P480Sclerosis (MS) Content than Non-slowly Evolving Lesions: (ePoster) Insights from a Sub-study of OPERA II

A Broad Effect of Ocrelizumab on the Peripheral Immune Component in Patients #P701 with Early Relapsing-remitting Multiple (ePoster) Sclerosis The Effectiveness of Ocrelizumab in #P828 Real-world Patients with Relapsing Multiple (ePoster) Sclerosis Over 18 months: A CONFIDENCE Interim Analysis

Efficacy and Safety of Ocrelizumab in #P627 Patients with RRMS with Suboptimal Response (ePoster) to Prior Disease-modifying Therapies: Thursday, 3-Year Data from CASTING and LIBERTO 1-Year October 14 Interim Results 12:00 - 12:05 PM ET Recently Diagnosed Early-stage RRMS: NEDA, ARR, Disability Progression, Serum #P628 Neurofilament and Safety: Full Cohort (ePoster) 1-Year Data from the Ocrelizumab Phase IIIb ENSEMBLE Study A Brain White Matter Atlas of Probabilistic #P411 Lesion Distribution in All Forms of (ePoster) Multiple Sclerosis

Demographic Features and Clinical Course of #P654 Pediatric-onset MS Patients on Newer Used (ePoster) Disease-modifying Treatments

#P783 COVID-19 Infections and Vaccinations in the (ePoster) Swiss Multiple Sclerosis Cohort Study

Pregnancy and Infant Outcomes in Women #P641 Receiving Ocrelizumab for the Treatment of (ePoster) Multiple Sclerosis

Rationale and Design of a Phase 4 Study Exploring B-cell Levels and Immune Responses in Infants Born to Women with MS #P655 Who Were Exposed to Ocrelizumab Up to 6 (ePoster) Months Before or During the First Trimester of Pregnancy (the MINORE Study)

B-cell Levels and Immunity in Breastfed #P686 Infants of Women with MS Treated with (ePoster) Ocrelizumab: Design of a Phase 4 Study (SOPRANINO)

Real World Experience with Ocrelizumab in #P117 Patients with Primary Progressive Multiple (ePoster) Sclerosis: Insights from the German NeuroTransData Registry

CELLO: A Phase IV, Multicenter, Randomized, #P702 Double-blind, Placebo-controlled Study (ePoster) Assessing Efficacy of Ocrelizumab in Radiologically Isolated Syndrome

Impact of the COVID-19 Pandemic on #P830 Healthcare Utilization in U.S. People (ePoster) Living with Multiple Sclerosis: An Analysis of the FlywheelMS Cohort

A Patient-focused Qualitative Study to #P309 Support Content Validity of Digital (ePoster) Performance Assessments in MS

Novel Smartphone Sensor-based Scores for #P306 Remote Measurement of Gait and Hand (ePoster) Function Impairment in People with MS

A Digital Remote Monitoring Assessment for #P303Floodlight Measuring Impairment in Information (ePoster)for MS Processing Speed in People with MS

Establishing Consensus Definitions of #P308 Smartphone-based Digital Outcome (ePoster) Measurements in Multiple Sclerosis

The Importance of Quality Checks for #P305 Digital Health Studies Using Remote (ePoster) Unsupervised Assessments to Study Functional Impairment in MS

Fenebrutinib Reduces Disease Activity in a #P680Fenebrutinib for MS Mouse Model of Inflammatory Multiple (ePoster) Sclerosis, which is Associated with Reduced Microglial Activation

Long-Term Safety of Satralizumab in NMOSD: #P023 Results from the Open-label Extension (ePoster) Periods of SAkuraSky and SAkuraStar

Long-term Efficacy of Satralizumab in #P024 Aquaporin-4-IgG- Seropositive NMOSD: (ePoster) Results from the Open-label Extension Periods of SAkuraSky and SAkuraStar

SAkuraBONSAI: A Prospective, Open-label #P039 Study of Satralizumab Investigating Novel (ePoster) Imaging, Biomarker, and Clinical Outcomes in Patients with AQP4-IgG Seropositive NMOSD

Exploring Steroid Tapering in NMOSD #P038 Patients Treated with Satralizumab in the (ePoster) Open-label Extension Period of SAkuraSky: A Case Series

Characterization of a Neuromyelitis OpticaEnspryng Mice Model Induced #P321(satralizumab-mwge) (ePoster)for Neuromyelitis by AQP4 Peptide ImmunizationOptica SpectrumDisorder (NMOSD) #P031 Novel Assessment of Disability vs Cognition (ePoster) and Pain in NMOSD: A CIRCLES Cohort Study

#P030 Novel Disability Assessment of NMOSD (ePoster) Derived from the CIRCLES Experience

Using Cognitive Interviews to Develop a #P049 Conceptual Claims-Based Algorithm to (ePoster) Identify Patients with NMOSD

Comparing Healthcare Resource Utilization #P041 and Costs of Active and Inactive Periods in (ePoster) NMOSD

#P045 Evaluating the Economic and Healthcare (ePoster) Resource Burden Posed by NMOSD

Multinomial Modeling Reveals Insights into #P984 Disability in NMOSD: A CIRCLES Cohort (ePoster) Analysis

About Ocrevus(r) (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:

* itchy skin * trouble breathing * nausea * shortness of breath

* rash * throat irritation or * headache * fatigue pain

* hives * feeling faint * swelling of * fast heart the throat beat

* tiredness * fever * dizziness

* coughing or * redness on your face wheezing (flushing)

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.

* Infection: Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Infections are a common side effect, which can be serious. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away. Signs of herpes include cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone. Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus. PML is a rare brain infection that usually leads to death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on 1 side of your body, strength, or using your arms or legs. Hepatitis B virus (HBV) reactivation: Before starting treatment with Ocrevus, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus. Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

* Low Immunoglobulins: Ocrevus may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

* have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS.

* have ever had hepatitis B or are a carrier of the hepatitis B virus.

* have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required 'live' or 'live-attenuated' vaccines at least 4 weeks before you start treatment with Ocrevus. You should not receive 'live' or 'live-attenuated' vaccines while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened. When possible, you should receive any 'non-live' vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus, talk to your healthcare provider. If you are pregnant or planning to become pregnant talk to your doctor about vaccinations for your baby, as some precautions may be needed.

* are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus. Talk with your healthcare provider about what birth control method is right for you during this time. If you become pregnant while taking Ocrevus, talk to your doctor about enrolling in the Ocrevus Pregnancy Registry. You can enroll in this registry by calling 1-833-872-4370 or visiting http://www.Ocrevuspregnancyregistry.com. The purpose of this registry is to monitor the health of you and your baby.

* are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus.

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?

Ocrevusmay cause serious side effects, including:

* Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider's instructions about standard screening guidelines for breast cancer.

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 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. 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.

Indications and Important Safety Information

Patients should not take Enspryng if they:

* are allergic to satralizumab-mwge or any of the ingredients in Enspryng * have an active hepatitis B infection * have active or untreated inactive (latent) tuberculosis (TB)

Enspryng may cause serious side effects including:

* Infections. Enspryng can increase risk of serious infections some of which can be life-threatening. Patients should speak with their healthcare provider if they are being treated for an infection and call right away if there are signs of an infection, with or without a fever, such as: chills, feeling tired, muscle aches, cough that will not go away or a sore throat skin redness, swelling, tenderness, pain or sores on the body diarrhea, belly pain, or feeling sick burning when urinating or urinating more often than usual A healthcare provider will check for infection and treat it if needed before starting or continuing to take Enspryng A healthcare provider should test for hepatitis and TB before initiating Enspryng All required vaccinations should be completed before starting Enspryng. People using Enspryng should not be given 'live' or 'live-attenuated' vaccines. 'Live' or 'live-attenuated' vaccines should be given at least 4 weeks before a patient starts Enspryng. A healthcare provider may recommend that a patient receive a 'non-live' (inactivated) vaccine, such as some of the seasonal flu vaccines. If a patient plans to get a 'non-live' (inactivated) vaccine it should be given, whenever possible, at least 2 weeks before starting Enspryng

* Increased liver enzymes. A healthcare provider should order blood tests to check patient liver enzymes before and while taking Enspryng. A healthcare provider will dictate how often these blood tests are needed. Patients should complete all follow-up blood tests as ordered by a healthcare provider. A healthcare provider may wait to start Enspryng if liver enzymes are increased

* Low neutrophil count. Enspryng can cause a decrease in neutrophil counts in the blood. Neutrophils are white blood cells that help the body fight off bacterial infections. A healthcare provider should order blood tests to check neutrophil counts while a patient is taking Enspryng.

* Serious allergic reactions that may be life-threatening have happened with other medicines like Enspryng. Patients should call their healthcare provider right away if they have any of these symptoms of an allergic reaction: shortness of breath or trouble breathing swelling of lips, face, or tongue dizziness or feeling faint moderate or severe stomach (abdominal) pain or vomiting chest pain

Before taking Enspryng, patients should tell their healthcare provider about all of their medical conditions, including if they:

* have or think they have an infection * have liver problems * have ever had hepatitis B or are a carrier of the hepatitis B virus * have had or have been in contact with someone with TB * have had a recent vaccination or are scheduled to receive any vaccination * are pregnant, think they might be pregnant, or plan to become pregnant. It is not known if Enspryng will harm one's unborn baby * are breastfeeding or plan to breastfeed. It is not known if Enspryng passes into breast milk. Patients should speak with their healthcare provider about the best way to feed one's baby while on treatment with Enspryng

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:

* sore throat, runny nose (nasopharyngitis) * headache * upper respiratory tract infection * rash * fatigue * nausea * extremity pain * inflammation of the stomach lining * joint pain

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.

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