PRESS RELEASE: OCREVUS (OCRELIZUMAB) DATA SHOW EARLY INITIATION OF TREATMENT REDUCES DISABILITY PROGRESSION OVER FIVE YEARS IN RELAPSING AND PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
Dear Advocates,
OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression over Five Years in Relapsing and Primary Progressive Multiple Sclerosis
- People with relapsing MS (RMS) treated sooner with OCREVUS had earlier reduction in disease activity and less disability progression vs. those who switched from interferon beta-1α
- People with primary progressive MS (PPMS) treated with OCREVUS earlier had less disability and upper limb progression than those who switched from placebo
- Longer-term safety data are consistent with OCREVUS’ favorable benefit-risk profile for both RMS and PPMS
- OCREVUS approved in 68 countries, with over 70,000 patients treated globally
South San Francisco, CA — October 9, 2018 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS® (ocrelizumab) data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 10-12 in Berlin, Germany. Five-year data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO show OCREVUS efficacy is maintained on key measures of disease activity and that people treated earlier with OCREVUS had superior disability progression outcomes compared with RMS patients who switched from interferon beta-1α or PPMS patients who switched from placebo.
“From the moment of diagnosis, reducing disease progression is an important goal for people with MS. The new data presented at ECTRIMS demonstrate that OCREVUS’ efficacy continued over five years in relapsing and primary progressive MS, and notably, include the largest body of evidence for any medicine to significantly slow disability progression in primary progressive MS,” said Stephen Hauser, M.D., chair of the Scientific Steering Committee of the OPERA studies, professor of neurology at the University of California, San Francisco, and director of the UCSF Weill Institute for Neurosciences. “The data also suggest that OCREVUS rapidly suppressed relapse and MRI disease activity in people with relapsing MS who switched from interferon beta-1α, and additionally, that earlier treatment with OCREVUS reduced disability progression and brain atrophy.”
In the open-label extension of the Phase III OPERA I and OPERA II trials, people with RMS who had continuous OCREVUS treatment over five years had better outcomes in brain atrophy and confirmed disability progression (CDP) than patients who switched to OCREVUS after the first two years of interferon beta-1α treatment. People with RMS who initiated OCREVUS two years earlier maintained lower whole brain, white matter and cortical grey matter tissue loss after five years of continuous treatment. People with RMS who initiated OCREVUS treatment two years earlier achieved significant and sustained reductions in 24-week CDP compared to those who switched from interferon beta-1α (16.1 percent vs. 21.3 percent progression after Year 5, respectively, p=0.014).
Additionally, people with RMS who switched to OCREVUS from interferon beta-1α after the controlled trial period had a rapid suppression of disease activity, measured with annualized relapse rate and MRI measures of T1-gadolinium enhancing (T1-Gd+) lesions and new/enlarging T2 (N/E T2) lesions. Switching to OCREVUS reduced the annualized relapse rate from 0.2 pre-switch to 0.07 after three years of OCREVUS treatment. People also experienced near-complete suppression of T1-gadolinium enhancing (T1-Gd+) lesions from 0.49 lesions/scan on interferon beta-1α treatment to 0.004 lesions/scan after three years of OCREVUS treatment. Similarly, the number of new or enlarging T2 (N/E T2) lesions were suppressed from 2.58 to 0.038 lesions/scan.
PPMS patients who were treated with OCREVUS three to five years earlier had less disability progression in the open-label extension study of the Phase III ORATORIO trial. Disability progression was significantly reduced by 9.6 percent in people who were continuously treated with OCREVUS compared with those who switched from placebo as measured by 24-week CDP (p=0.023). Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was significantly reduced by 13.4 percent in people who were continuously treated with OCREVUS compared with those who switched from placebo (p=0.001).
Furthermore, data from the open-label Phase IIIb CHORDS study evaluating OCREVUS in people with relapsing-remitting MS (RRMS) who had a suboptimal response to at least six months of treatment with another disease-modifying therapy will be presented. An interim analysis shows 59 percent of people who switched to OCREVUS had no relapse, no T1-Gd+ lesion MRI activity, no N/E T2 lesion MRI activity and no 24-week CDP at 48 weeks.
Ongoing safety data presented at ECTRIMS representing 3,811 RMS and PPMS patients and 10,919 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, remain consistent with the medicine’s favorable benefit-risk profile.
A post-hoc analysis of the ORATORIO study demonstrating OCREVUS treatment increased the proportion of patients with PPMS who achieved no evidence of progression or active disease (NEPAD), a comprehensive measure of MS, compared to placebo were published August 29, 2018 in Annals of Neurology.
OCREVUS is now approved in 68 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.
Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2018 news and updates by using the hashtag #ECTRIMS2018.
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-1α (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-1α 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 had 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 have 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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