Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis
Genentech announced that its Phase III MUSETTE trial, testing a higher dose of Ocrevus (ocrelizumab) against the standard 600 mg dose in relapsing multiple sclerosis (RMS), did not meet its primary endpoint of showing additional benefit in slowing disability progression.
The study revealed that disability progression rates remained low and consistent with previous pivotal studies. The standard 600 mg dose demonstrated strong efficacy with the lowest annualized relapse rate (ARR) observed in any Phase III RMS study, with relapses occurring approximately once every 16 years.
Ocrevus, the first B-cell therapy approved for RMS and PPMS, has become the most prescribed disease-modifying therapy in the United States, treating over 400,000 patients globally. The company is developing new delivery methods, including Ocrevus Zunovo™ and a high-concentration formulation for on-body device delivery.
Genentech ha annunciato che il suo studio di Fase III MUSETTE, che testava una dose più alta di Ocrevus (ocrelizumab) rispetto alla dose standard di 600 mg nella sclerosi multipla recidivante (RMS), non ha raggiunto il suo obiettivo primario di dimostrare un beneficio aggiuntivo nel rallentare la progressione della disabilità.
Lo studio ha rivelato che i tassi di progressione della disabilità sono rimasti bassi e coerenti con studi fondamentali precedenti. La dose standard di 600 mg ha dimostrato una forte efficacia con il tasso di recidiva annualizzato (ARR) più basso osservato in qualsiasi studio di Fase III sulla RMS, con recidive che si verificano circa una volta ogni 16 anni.
Ocrevus, la prima terapia a base di cellule B approvata per RMS e PPMS, è diventata la terapia modificante la malattia più prescritta negli Stati Uniti, trattando oltre 400.000 pazienti a livello globale. L'azienda sta sviluppando nuovi metodi di somministrazione, inclusi Ocrevus Zunovo™ e una formulazione ad alta concentrazione per la somministrazione tramite dispositivo indossabile.
Genentech anunció que su ensayo de Fase III MUSETTE, que prueba una dosis más alta de Ocrevus (ocrelizumab) en comparación con la dosis estándar de 600 mg en esclerosis múltiple recurrente (RMS), no cumplió con su objetivo primario de mostrar un beneficio adicional en la reducción de la progresión de la discapacidad.
El estudio reveló que las tasas de progresión de la discapacidad se mantuvieron bajas y consistentes con estudios clave anteriores. La dosis estándar de 600 mg demostró una fuerte eficacia con la tasa de recaída anualizada (ARR) más baja observada en cualquier estudio de Fase III de RMS, con recaídas ocurriendo aproximadamente una vez cada 16 años.
Ocrevus, la primera terapia con células B aprobada para RMS y PPMS, se ha convertido en la terapia modificadora de la enfermedad más prescrita en los Estados Unidos, tratando a más de 400,000 pacientes en todo el mundo. La empresa está desarrollando nuevos métodos de entrega, incluidos Ocrevus Zunovo™ y una formulación de alta concentración para la entrega a través de dispositivos portátiles.
제넨텍은 오크레부스 (오크렐리주맙)의 고용량을 표준 600mg 용량과 비교하여 재발성 다발성 경화증 (RMS)에서 시험하는 3상 MUSETTE 임상시험이 장애 진행 속도를 늦추는 추가 이점을 보여주는 주요 목표를 달성하지 못했다고 발표했습니다.
연구 결과, 장애 진행률은 낮고 이전의 주요 연구와 일치하는 것으로 나타났습니다. 표준 600mg 용량은 모든 3상 RMS 연구에서 관찰된 가장 낮은 연간 재발률 (ARR)을 보여주었으며, 재발은 약 16년에 한 번 발생했습니다.
오크레부스는 RMS 및 PPMS에 대해 승인된 최초의 B세포 치료제로, 미국에서 가장 많이 처방되는 질병 수정 치료제가 되었으며 전 세계적으로 40만 명 이상의 환자를 치료하고 있습니다. 이 회사는 Ocrevus Zunovo™ 및 신체 장치 투여를 위한 고농도 제형을 포함한 새로운 전달 방법을 개발하고 있습니다.
Genentech a annoncé que son essai de Phase III MUSETTE, testant une dose plus élevée de Ocrevus (ocrelizumab) par rapport à la dose standard de 600 mg dans la sclérose en plaques récurrente (RMS), n'a pas atteint son objectif principal de montrer un bénéfice supplémentaire dans le ralentissement de la progression du handicap.
L'étude a révélé que les taux de progression du handicap sont restés bas et cohérents avec des études pivots précédentes. La dose standard de 600 mg a démontré une forte efficacité avec le taux de rechute annualisé (ARR) le plus bas observé dans n'importe quelle étude de Phase III sur la RMS, avec des rechutes survenant environ une fois tous les 16 ans.
Ocrevus, la première thérapie à base de cellules B approuvée pour la RMS et la PPMS, est devenue la thérapie modifiant la maladie la plus prescrite aux États-Unis, traitant plus de 400 000 patients dans le monde. L'entreprise développe de nouvelles méthodes d'administration, y compris Ocrevus Zunovo™ et une formulation à haute concentration pour l'administration via un dispositif portable.
Genentech gab bekannt, dass die Phase-III-Studie MUSETTE, die eine höhere Dosis von Ocrevus (Ocrelizumab) gegen die Standarddosis von 600 mg bei rezidivierenden multiplen Sklerose (RMS) testete, ihr primäres Ziel, einen zusätzlichen Nutzen bei der Verlangsamung der Behinderungsprogression zu zeigen, nicht erreicht hat.
Die Studie zeigte, dass die Raten der Behinderungsprogression niedrig und konsistent mit früheren entscheidenden Studien blieben. Die Standarddosis von 600 mg zeigte eine starke Wirksamkeit mit der niedrigsten jährlichen Rückfallrate (ARR), die in einer Phase-III-Studie zur RMS beobachtet wurde, wobei Rückfälle etwa alle 16 Jahre auftraten.
Ocrevus, die erste B-Zell-Therapie, die für RMS und PPMS zugelassen wurde, ist die am häufigsten verschriebene krankheitsmodifizierende Therapie in den Vereinigten Staaten und behandelt weltweit über 400.000 Patienten. Das Unternehmen entwickelt neue Verabreichungsmethoden, darunter Ocrevus Zunovo™ und eine hochkonzentrierte Formulierung für die Verabreichung über tragbare Geräte.
- Current 600 mg dose achieved lowest annualized relapse rate in Phase III RMS studies
- Strong market position as most prescribed MS therapy in US with 400,000+ global patients
- Development of new delivery methods to improve treatment accessibility
- High dose showed comparable safety profile with no new safety signals
- Higher dose failed to show additional benefits in disability progression
- No improvement over current treatment efficacy despite increased dosage
- MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis -
- The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression -
- High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed -
- These data further support the efficacy and safety profile of Ocrevus IV 600 mg dose for RMS -
- Ocrevus set a new standard of care in multiple sclerosis and is the most prescribed disease modifying therapy in
“Ocrevus is the first and only B-cell therapy approved for RMS and PPMS and after more than ten years of treatment, the majority of people with RMS remain free from disease progression,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “These findings reaffirm that the current Ocrevus IV 600 mg is optimally dosed to significantly slow disability progression. Moreover, in several predefined analyses on disease activity, Ocrevus showed clinically meaningful results on relapses with a relapse occurring approximately once every 16 years, a first for an anti-CD20 RMS medicine.”
Since its launch, Ocrevus has set a new standard of care in MS and is the most prescribed disease modifying therapy in
In addition to Ocrevus, Roche has a diverse and promising pipeline of formulations and targets, such as Brainshuttle™ CD20 and a monoacylglycerol lipase (MAGL) inhibitor in early-stage development and Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib in Phase III studies for both RMS and primary progressive multiple sclerosis (PPMS).
Full data from MUSETTE will be presented at an upcoming medical meeting.
About Ocrevus
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. 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 IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the
About the MUSETTE study
MUSETTE (NCT04544436) is a Phase III randomized, double-blind, controlled, parallel-group, multicenter trial to evaluate the efficacy, safety and pharmacokinetics of a high dose of Ocrevus intravenous (IV) infusion (1,200 mg for patients <75 kg or 1,800 mg for patients ≥75 kg) in adult patients with relapsing multiple sclerosis (RMS) compared with the currently approved Ocrevus IV 600 mg dose. Patients received treatment with Ocrevus high dose or IV 600 mg every 24 weeks for a minimum of 120 weeks.
The primary endpoint was the time to first onset of 12-week composite confirmed disability progression (cCDP), defined as any of the following events sustained for 12 weeks: an increase of ≥1.0 point from the baseline Expanded Disability Status Scale (EDSS) score if the baseline EDSS score was ≤5.5 or an increase of ≥0.5 points if the baseline EDSS score was >5.5; a ≥
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than 2.9 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 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 acquired 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 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 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
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, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy 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 Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process and to providing assistance to eligible patients in
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
Indications and Important Safety Information
What are OCREVUS and OCREVUS ZUNOVO?
OCREVUS and OCREVUS ZUNOVO are prescription medicines 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 and OCREVUS ZUNOVO are safe and effective in children.
Who should not receive OCREVUS or OCREVUS ZUNOVO?
Do not receive OCREVUS or OCREVUS ZUNOVO if you:
- have an active hepatitis B virus (HBV) infection.
- have had a life-threatening administration reaction to ocrelizumab.
- have had a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of OCREVUS ZUNOVO. Tell your healthcare provider if you have had an allergic reaction to OCREVUS or OCREVUS ZUNOVO or any of their ingredients in the past.
What is the most important information I should know about OCREVUS and OCREVUS ZUNOVO?
OCREVUS and OCREVUS ZUNOVO can cause serious side effects, including:
Infusion reactions (OCREVUS): 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.
Injection reactions (OCREVUS ZUNOVO): Injection reactions are a common side effect of OCREVUS ZUNOVO, which can be serious and may require you to be hospitalized. You will be monitored for signs and symptoms of an injection reaction when you receive OCREVUS ZUNOVO. This will happen during all injections for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection.
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 pain
- headache
- fatigue
- hives
- feeling faint
- swelling of the throat
- fast heartbeat
- tiredness
- fever
- dizziness
- coughing or wheezing
- redness on your face (flushing)
Additionally, for OCREVUS ZUNOVO:
- injection site pain
- swelling
- redness
These infusion and injection reactions can happen during or up to 24 hours after administration. 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 or injection.
Infection:
Infections are a common side effect. OCREVUS and OCREVUS ZUNOVO increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with OCREVUS and OCREVUS ZUNOVO, which can be life-threatening or cause death. 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, or painful urination. Signs of herpes infection 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 or OCREVUS ZUNOVO. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS or OCREVUS ZUNOVO until your infection is gone.
Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, 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 or OCREVUS ZUNOVO. 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 or OCREVUS ZUNOVO.
Weakened immune system: OCREVUS or OCREVUS ZUNOVO 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 ocrelizumab. 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 and OCREVUS ZUNOVO 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 or OCREVUS ZUNOVO, tell your healthcare provider about all of your medical conditions, including if you:
- have or think you have an infection. See “What is the most important information I should know about OCREVUS and OCREVUS ZUNOVO?”
- have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
- have ever had hepatitis B or are a carrier of the hepatitis B virus.
- have a history of inflammatory bowel disease or colitis.
- 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 or OCREVUS ZUNOVO. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with OCREVUS or OCREVUS ZUNOVO 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 or OCREVUS ZUNOVO. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with OCREVUS or OCREVUS ZUNOVO, talk to your healthcare provider.
If you have a baby and you received OCREVUS or OCREVUS ZUNOVO during your pregnancy, it is important to tell your baby’s healthcare provider about receiving OCREVUS or OCREVUS ZUNOVO 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 and OCREVUS ZUNOVO will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and OCREVUS ZUNOVO and for 6 months after your last dose of OCREVUS or OCREVUS ZUNOVO. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving OCREVUS or OCREVUS ZUNOVO.
- are breastfeeding or plan to breastfeed. It is not known if OCREVUS and OCREVUS ZUNOVO pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS or OCREVUS ZUNOVO.
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 and OCREVUS ZUNOVO?
OCREVUS and OCREVUS ZUNOVO 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
The most common side effects of OCREVUS ZUNOVO include:
- Injection reactions
- Respiratory tract infections
- Skin infections
These are not all the possible side effects of OCREVUS and OCREVUS ZUNOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.
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 full Prescribing Information and Medication Guide for OCREVUS.
Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide for OCREVUS ZUNOVO.
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Source: Genentech
FAQ
What were the results of Genentech's MUSETTE trial for higher dose Ocrevus (RHHBY)?
How effective is the current Ocrevus 600 mg dose for relapsing multiple sclerosis?
How many patients globally are currently treated with Ocrevus (RHHBY)?
What new delivery methods is Genentech developing for Ocrevus (RHHBY)?
