Genentech Press Release - New Data for Genentech's Ocrevus (Ocrelizumab) Show Benefit in Disability Progression and Cognitive Decline in Both Secondary Progressive and Primary Progressive Multiple Sclerosis Montag, 04. April 2022 - 07:14

New Data for Genentech's Ocrevus (Ocrelizumab) Show Benefit in Disability Progression and Cognitive Decline in Both Secondary Progressive and Primary Progressive Multiple Sclerosis

75% of patients with secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS) achieved no evidence of progression (NEP) in a one-year interim analysis of CONSONANCE study

70% of patients with SPMS and PPMS demonstrated stable or improved cognition after one year of Ocrevus treatment in CONSONANCE

Separate analysis on treatment disparities showed fewer Black and Hispanic patients with MS initiate high-efficacy treatments within two years of diagnosis

Data at AAN support the body of evidence for Ocrevus more than 450,000 patient years and more than 225,000 patients treated globally

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new Ocrevus® (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN) Annual Meeting April 2-7, 2022 in Seattle. CONSONANCE data will be presented virtually at AAN April 24-26, 2022.

“We continue to work on closing treatment gaps for all people impacted by MS, as everyone living with this neurodegenerative condition experiences disease progression from the start. For people with progressive forms of MS and in some Black and Hispanic subpopulations, the disease may progress faster,” said Levi Garraway, M.D., Ph.D. chief medical officer and head of Global Product Development. “We are encouraged by the low levels of disability progression and cognitive decline in Ocrevus-treated patients seen across the complete spectrum of progressive MS for the first time, since SPMS and PPMS often bring a substantial quality of life burden.”

Treatment with Ocrevus resulted in a majority of patients experiencing no disease progression in a one-year analysis of CONSONANCE, a first-of-its-kind open-label Phase IIIb trial to evaluate the effect of Ocrevus in SPMS and PPMS patients. After one year, 75% of Ocrevus-treated patients with SPMS and PPMS achieved No Evidence of Progression (NEP; no evidence of confirmed disability progression as measured by an increase in Expanded Disability Status Score sustained for at least 24 weeks, and less than 20% worsening of performance on the timed 25-foot walk [T25-FW] and Nine-Hole Peg Test [9-HPT]). NEP is a novel composite endpoint and reflects no evidence of worsening of a person’s physical disability.

Additionally, 59% of Ocrevus-treated patients in the trial achieved No Evidence of Progression or Active Disease (NEPAD; NEP plus no protocol-defined relapses, new and/or enlarging T2 lesions or T1 gadolinium-enhancing lesions) over one year. NEPAD is another novel composite endpoint and reflects no evidence of clinical or MRI disease activity or worsening of a person’s physical disability. Progression was primarily driven by T25-FW (16% of patients) and activity of new and/or enlarging T2 lesions (19% of patients), detected almost exclusively within the first six months of the trial.

The analysis also demonstrated the positive effects of Ocrevus on cognition, with 70% of patients having stable or improved cognition over one year, as measured with the Symbol Digit Modalities Test (SDMT). Clinically meaningful improvement (increase of ≥4 points on the SDMT) was observed in 34% of patients treated with Ocrevus and worsening (decrease of ≥4 points) in 30% of patients treated with Ocrevus. At enrollment, patients had moderate-to-severe dysfunction in information processing speed and visuospatial memory, which was stable or improved in a majority of patients after Ocrevus treatment.

After one year of participating in the trial, 75% of patients had one or more adverse events (AEs) and 7% experienced at least one serious AE. The interim analysis included 629 patients, and longer-term evaluation of Ocrevus will continue for four years with a target of 900 patients with PPMS or SPMS (in a 1:1 ratio) across 26 countries.

Continued research on the treatment patterns of minority populations living with MS

Current treatment guidelines recommend the initiation of high-efficacy disease modifying therapies (DMTs) for patients with highly active disease, as frequently seen with Black and Hispanic populations. However, a recent analysis of a U.S. commercial claims database found that only 30% of non-Hispanic Black, and 20% of Hispanic patients initiated any high-efficacy DMTs, in comparison to 39% of non-Hispanic white patients in the first two years after diagnosis.

These insights further support Genentech’s Phase IV ‘Characterization of ocrelizumab in Minorities with Multiple Sclerosis’ (CHIMES) trial in Black/African-American and Hispanic/Latino patients with relapsing MS (RMS). The results are expected to improve the current understanding of MS disease biology and treatment response to Ocrevus among these populations with MS, to improve standard of care in traditionally underserved communities and improve inclusivity in clinical research.

With rapidly growing real-world experience and more than 225,000 people treated globally, Ocrevus is the first and only therapy approved for relapsing MS (RMS; including relapsing-remitting MS [RRMS] and active SPMS, in addition to clinically isolated syndrome [CIS] in the United States) 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 approved for eligible people with RMS or PPMS in the United States and European Union (EU).

Ocrevus is approved in 100 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 (MS)
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 United States) 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.

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
• rash
• hives
• tiredness
• coughing or wheezing
• trouble breathing
• throat irritation or pain
• feeling faint
• fever
• redness on your face (flushing)
• nausea
• headache
• swelling of the throat
• dizziness
• shortness of breath
• fatigue
• fast heart beat

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.

• 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.

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:

• 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 infection

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 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.