Tuesday, Oct 10, 2023

First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity

Black and Hispanic / Latinx people with multiple sclerosis (MS) often experience more severe disease and greater disability

 

Results from the Phase IV CHIMES trial demonstrate safety and efficacy consistent with data from the Ocrevus Phase III studies

 

CHIMES sets new standard for inclusive research in MS, providing critical insights for improving clinical trial recruitment and retention among historically underrepresented communities

South San Francisco, CA -- October 10, 2023 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial evaluating Ocrevus^® (ocrelizumab) in Black and Hispanic / Latinx people with relapsing multiple sclerosis (MS). One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations. Approximately half of all trial participants (n=182) achieved no evidence of disease activity (NEDA) at week 48 (46% of Black participants; 58% of Hispanic / Latinx participants), with over 94% of participants experiencing no relapses (94.7% of Black participants; 95.7% of Hispanic / Latinx participants) during this period. The safety and efficacy profile demonstrated in the trial was consistent with the large body of clinical evidence from other Ocrevus studies. The results (abstract #P691) were presented at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis) in Milan.

 

“We know that Black and Hispanic / Latinx people with MS often experience more severe disease and greater disability compared with their white counterparts. But until now, there has been limited research conducted in these populations,” said Mitzi Joi Williams, M.D., lead trial investigator and founding medical director at Joi Life Wellness MS Center. “The CHIMES trial is a critical step in breaking the cycle of health inequity. The results, for the first time, provide evidence on the benefit of treatment in Black and Hispanic / Latinx people with MS. The study unlocks new insights into the role of social determinants of health in the recruitment and retention of these populations in clinical trials.”

 

Additional results from the CHIMES trial showed more than 90% of trial participants had no 24-week confirmed disability progression (94.7% of Black participants; 94.2% of Hispanic / Latinx participants) and no T1-Gd+ lesions (95% of Black participants; 97% of Hispanic / Latinx participants). During the trial period, no new or enlarging T2 lesions were observed in about half of Black participants (46%) and more than half of Hispanic / Latinx participants (64%). No new safety signals were reported.   

 

Black and Hispanic / Latinx communities often face socioeconomic and cultural barriers to care that contribute to inequitable differences in health outcomes. Despite making up almost 20% of the MS population,¹ Black and Hispanic / Latinx people living with the disease are vastly underrepresented in clinical research. This has limited the collection of complete and accurate data on the disease biology of MS in these populations. Genentech designed the CHIMES trial in collaboration with people living with MS, advocacy groups and clinical investigators to broaden understanding of MS progression and response to treatment in Black and Hispanic / Latinx populations. 

 

“The CHIMES trial delivers on our intention to lay a strong foundation for more equitable and inclusive care for everyone with MS,” said Quita Highsmith, vice president and chief diversity officer at Genentech. “Research has shown that MS is more common in Black and Hispanic / Latinx people than previously thought, so it is urgent that we understand how to best care for these communities through high-efficacy disease-modifying treatment.”     

 

The CHIMES trial has set a new standard for inclusive clinical research, incorporating proactive measures to overcome circumstantial barriers to recruitment and promote retention among Black and Hispanic / Latinx people with MS. Trial sites, across the U.S., Kenya and Puerto Rico, included academic institutions, hospitals, outpatient clinics, community centers and healthcare provider practices. To facilitate enrollment, trial-related materials were available in multiple languages (English, Spanish and Swahili) and reviewed by an advisory panel to ensure understanding and cultural appropriateness. Trial participants were offered flexible scheduling options; appropriate compensation or reimbursement for loss of earnings, childcare, accommodation, travel and meals; and utilization of ride-sharing companies for transportation. The CHIMES trial has been extended to three years to gather long-term data on MS progression among Black and Hispanic / Latinx populations, with further results anticipated to be available in 2024.

 

About the CHIMES study

The CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis (CHIMES) trial is the first-ever clinical trial that exclusively focuses on broadening understanding of MS disease biology among Black and Hispanic / Latinx people living with MS. The Phase IV, prospective, open-label, single-arm, multi-center trial is assessing disease activity and biomarkers of neuronal damage in Black and Hispanic / Latinx participants with relapsing MS who are receiving treatment with Ocrevus. The primary endpoint is the proportion of participants with no evidence of disease activity (NEDA) during a 48-week period on treatment. Key secondary endpoints include the proportion of participants free of a protocol-defined event during a 24-week period; confirmed disability progression (CDP) at weeks 24 and 48; and serum biomarkers, including neurofilament light protein levels, B-cell subpopulations and other markers of inflammation. 

 

Insights and key learnings from the CHIMES trial design are being applied across other Genentech clinical programs, including the FENopta trial in MS. The trial will serve as a successful model as Genentech continues to progress toward its 2025 D&I commitments to ensure all clinical programs for investigational medicines include population-specific assessments and inclusive research action plans. 

 

About Ocrevus

Ocrevus is the first and only therapy approved for both relapsing forms of MS (RMS) (including relapsing-remitting MS [RRMS] and active, or relapsing secondary progressive MS [SPMS]), in addition to clinically isolated syndrome [CIS] in the U.S.) and primary progressive MS (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.

 

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. 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 – from 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, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression 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 FDA approval of Ocrevus, there had been no FDA-approved treatments for PPMS.

 

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
• 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

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.
• 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.
• Progressive Multifocal Leukoencephalopathy (PML):   PML is a rare brain infection that usually leads to death or severe disability, and has been reported with Ocrevus. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
• thinking
• eyesight
• strength
• balance
• weakness on 1 side of your body
• using your arms or legs
• Decreased immunoglobulins: Ocrevus may cause a decrease in some types of immunoglobulins. 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 have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus so they can decide when your baby should be vaccinated.  
• 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.
• Pregnancy Registry. There is a pregnancy registry for women who take Ocrevus during pregnancy. If you become pregnant while receiving Ocrevus, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Ocrevus Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Your healthcare provider can enroll you in this registry by calling 1-833-872-4370 or visiting http://www.ocrevuspregnancyregistry.com.
• 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?

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.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
• Diarrhea (loose stools) or more frequent bowel movements than usual
• Stools that are black, tarry, sticky or have blood or mucus
• Severe stomach-area (abdomen) pain or tenderness

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 https://www.Ocrevus.com or call 1-844-627-3887.

 

Please see additional Important Safety Information throughout and click here for the full Prescribing Information and Medication Guide. 

 

About Genentech in Neuroscience 

Neuroscience is a major focus of research and development at Genentech. 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 MS, spinal muscular atrophy (SMA), neuromyelitis optica spectrum disorder (NMOSD), Alzheimer’s, Huntington’s, Parkinson’s, acute ischemic stroke, Duchenne muscular dystrophy and Angelman syndrome. 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.

 

References

¹Hittle M, et al. Population-Based Estimates for the Prevalence of Multiple Sclerosis in the United States by Race, Ethnicity, Age, Sex, and Geographic Region. JAMA Neurol. 2023;80(7):693-701.

 

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