Genentech to Present Five-Year OCREVUS (Ocrelizumab) Efficacy and Safety Data in Relapsing and Primary Progressive Multiple Sclerosis at ECTRIMS

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data on OCREVUS^® (ocrelizumab) in people with relapsing and primary progressive forms of MS will be presented during the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Berlin, Germany, October 10-12. Fifteen abstracts will be presented throughout the congress, including five-year efficacy and safety OCREVUS data and post-hoc analyses of the Phase III studies that evaluate OCREVUS in underrepresented MS patient populations.

A new analysis of the Phase III ORATORIO study shows OCREVUS treatment reduced upper limb disability progression similarly in PPMS patients with or without advanced overall disability (Expanded Disability Status Scale <6.0 and ≥6.0 and nine-hole peg test (9-HPT) times ≤25 seconds and >25 seconds). These analyses informed the ORATORIO-HAND trial, which for the first time ever will use the 9-HPT as the primary outcome to evaluate the long-term efficacy and safety of OCREVUS in people with PPMS including those later in their disease course.

A subgroup analysis of the Phase III OPERA I and OPERA II studies in RMS patients of African-descent, who usually have faster MS disease progression than other populations, showed OCREVUS treatment benefit on MRI and composite efficacy outcomes versus interferon beta-1α. A greater proportion of patients of African-descent treated with OCREVUS achieved no evidence of disease progression (NEDA) compared with interferon beta-1α (46 percent vs. 10 percent, respectively; p=0.002).

“We continue our commitment to people with MS by evaluating OCREVUS in groups that are often overlooked in clinical trials,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “In addition to now having five years of consistent efficacy and safety data results for OCREVUS, other data will be presented at ECTRIMS that advance the clinical understanding of MS. Our goal is to help the MS community better understand and manage their disease.”

New tools to rapidly assess the severity of MS symptoms are crucial to improving patient outcomes and optimizing care. SymptoMScreen, a novel patient-reported outcome tool to assess symptom severity across twelve domains (walking, hand function/dexterity, spasticity, bodily pain, sensation, bladder control, fatigue, vision, dizziness, cognitive function, depression and anxiety), will be used in two Phase IIIb OCREVUS trials (ENSEMBLE and CASTING). Baseline data from these studies show differences in disease severity on all domains, for example, 31 percent of patients in ENSEMBLE (treatment-naïve relapsing-remitting MS (RRMS) patients) and 41 percent of patients in CASTING (RRMS patients who have had a prior suboptimal response to a disease-modifying therapy) experienced moderate to severe fatigue.

Genentech will also present final primary endpoint data for the FLOODLIGHT proof-of-concept study evaluating an innovative smartphone-based self-monitoring technology. The data show FLOODLIGHT may be more sensitive than periodic in-clinic disability assessments. There was also high adherence to the technology, with 76 percent adherence to active tests and 71 percent adherence to passive monitoring. Results also showed that satisfaction among patients with MS who completed the study was good to excellent (patient-reported 75 average score out of a possible 100 at the last visit).

Based on initial results from the FLOODLIGHT proof-of-concept study, Genentech and Roche have initiated a new, global study called FLOODLIGHT Open with plans to enroll 10,000 people in five years. FLOODLIGHT Open will assess the feasibility of monitoring disease activity and disability progression over the 365 days in a year that someone lives with MS, versus the two or three days they visit with their neurologist. It is an open access study, which means anyone can join and the anonymous data collected through the study is freely available to doctors and scientists to help accelerate research and collaboration. FLOODLIGHT Open is currently enrolling in the United States and Canada, and will open in other countries later this year. To learn more and enroll, visit https://floodlightopen.com or download the FLOODLIGHT app on iTunes for iPhone or Google Play for Android.

OCREVUS is now approved in 67 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union. Marketing applications are currently under review in more than 20 countries across the world.

Additionally, Roche is sponsoring two symposia: “Disease activity: Can starting early with effective treatment offer better outcomes in MS?” on Wednesday, October 10 at 6:15 PM CEST in Hall A and “Disease progression: Changing how we think about MS” on Thursday, October 11 at 7:30 AM CEST in Hall B.

Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2018 news and updates by using the hashtag #ECTRIMS2018.

Genentech presentations at ECTRIMS 2018

A full list of Genentech presentations can be found at: https://www.ectrims-congress.eu/2018/scientific-programme/scientific-programme.html. Select poster presentations at ECTRIMS 2018 include:

About the OPERA I and OPERA II studies in relapsing forms of MS

OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses. A similar proportion of patients in the OCREVUS group experienced serious adverse events and serious infections compared with patients in the high-dose interferon beta-1a group in the RMS studies.

About the ORATORIO study in primary progressive MS

ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with primary progressive MS (PPMS). The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study. A similar proportion of patients in the OCREVUS group experienced adverse events and serious adverse events compared with patients in the placebo group in the PPMS study.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects an estimated 400,000 people in the U.S., for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the 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.

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 percent 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 percent of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there have been no FDA approved treatments for PPMS.

People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse. An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person’s disability progresses. Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.

About OCREVUS^® (ocrelizumab)

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 multiple sclerosis (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, and therefore 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.

OCREVUS U.S. Indication

OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.

It is not known if OCREVUS is safe or effective in children.

Important Safety Information

Who should not receive OCREVUS?

Do not receive OCREVUS if you are a patient that has an active hepatitis B virus (HBV) infection. Do not receive OCREVUS if you are a patient that has had a life threatening allergic reaction to OCREVUS. Patients should tell their healthcare provider if they have had an allergic reaction to OCREVUS or any of its ingredients in the past.

What is the most important information about OCREVUS?

OCREVUS can cause serious side effects, including:

• Infusion Reaction: OCREVUS can cause infusion reactions that can be serious and require a patient to be hospitalized. A patient will be monitored during the infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Patients should tell their healthcare provider or nurse if they get any of these symptoms: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the face (flushing), nausea, headache, swelling of the throat, dizziness, shortness of breath, fatigue, fast heart beat.

These infusion reactions can happen for up to 24 hours after the infusion. It is important that patients call their healthcare provider right away if they get any of the signs or symptoms listed above after each infusion. If a patient gets infusion reactions, the healthcare provider may need to stop or slow down the rate of the infusion.

• Infection: OCREVUS increases a patient’s risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Patients should tell their healthcare provider if they have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after a patient has received their last dose of OCREVUS. If a patient has an active infection, their healthcare provider should delay treatment with OCREVUS until the infection is gone.
• Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Patients should tell their healthcare provider right away if they have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on one side of the body, strength, or using arms or legs.
• Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, a patient’s healthcare provider will do blood tests to check for hepatitis B viral infection. If a patient has 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. A healthcare provider will monitor a patient if they are at risk for hepatitis B virus reactivation during treatment and after they stop receiving OCREVUS.
• Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase a patient’s risk of getting infections.

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

• have ever taken, take, or plan to take medicines that affect the 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. A patient should receive any required vaccines at least 6 weeks before they start treatment with OCREVUS. A patient should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while being treated with OCREVUS and until their healthcare provider tells them that their immune system is no longer weakened;
• are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm an unborn baby. Patients should use birth control (contraception) during treatment with OCREVUS and for 6 months after the last infusion of OCREVUS;
• are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into the breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if the patient takes OCREVUS.

What are possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Patients should follow their healthcare provider’s recommendations 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.

Patients should call their doctor for medical advice about side effects. Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see the OCREVUS full Prescribing Information and Medication Guide. For more information, go to http://www.OCREVUS.com or call 1-844-627-3887.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Genentech and Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Huntington’s disease and autism spectrum disorder.

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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