Roche provides update on Phase III OCREVUS high dose study in people with relapsing multiple sclerosis
Roche (RHHBY) announced that its Phase III MUSETTE trial, testing a higher dose of OCREVUS® (ocrelizumab) against the current 600 mg dose in relapsing multiple sclerosis (RMS), did not meet its primary endpoint of showing additional benefit in slowing disability progression over 120 weeks of treatment.
The study revealed that the current 600 mg dose demonstrated optimal efficacy, with disability progression rates remaining low and consistent with previous pivotal studies. Notably, OCREVUS showed the lowest annualized relapse rate ever observed in a Phase III RMS study, with relapses occurring approximately once every 16 years.
OCREVUS maintains its position as the most prescribed disease-modifying therapy in the United States, with over 400,000 patients treated globally. Roche is expanding treatment accessibility through a new subcutaneous formulation and is developing a high-concentration formulation for convenient on-body device delivery.
Roche (RHHBY) ha annunciato che il suo studio di Fase III MUSETTE, che testava una dose più alta di OCREVUS® (ocrelizumab) rispetto all'attuale dose di 600 mg nella sclerosi multipla recidivante (RMS), non ha raggiunto il suo obiettivo primario di dimostrare un ulteriore beneficio nel rallentare la progressione della disabilità dopo 120 settimane di trattamento.
Lo studio ha rivelato che la dose attuale di 600 mg ha mostrato un'efficacia ottimale, con tassi di progressione della disabilità che rimangono bassi e coerenti con studi pivotal precedenti. È importante notare che OCREVUS ha mostrato il tasso di recidiva annualizzato più basso mai osservato in uno studio di Fase III sulla RMS, con recidive che si verificano circa una volta ogni 16 anni.
OCREVUS mantiene la sua posizione come la terapia modificante la malattia più prescritta negli Stati Uniti, con oltre 400.000 pazienti trattati a livello globale. Roche sta ampliando l'accessibilità al trattamento attraverso una nuova formulazione sottocutanea e sta sviluppando una formulazione ad alta concentrazione per una somministrazione conveniente tramite dispositivo indossabile.
Roche (RHHBY) anunció que su ensayo de Fase III MUSETTE, que prueba una dosis más alta de OCREVUS® (ocrelizumab) en comparación con la dosis actual de 600 mg en esclerosis múltiple recurrente (RMS), no cumplió con su objetivo principal de mostrar un beneficio adicional en la ralentización de la progresión de la discapacidad durante 120 semanas de tratamiento.
El estudio reveló que la dosis actual de 600 mg mostró una eficacia óptima, con tasas de progresión de la discapacidad que se mantuvieron bajas y consistentes con estudios pivotal anteriores. Notablemente, OCREVUS mostró la tasa de recaída anualizada más baja jamás observada en un estudio de Fase III de RMS, con recaídas que ocurren aproximadamente una vez cada 16 años.
OCREVUS mantiene su posición como la terapia modificadora de la enfermedad más prescrita en los Estados Unidos, con más de 400,000 pacientes tratados a nivel global. Roche está ampliando el acceso al tratamiento a través de una nueva formulación subcutánea y está desarrollando una formulación de alta concentración para una entrega conveniente mediante un dispositivo portátil.
로슈 (RHHBY)는 재발성 다발성 경화증 (RMS)에서 현재의 600mg 용량에 대한 OCREVUS® (오크렐리주맙)의 고용량을 시험하는 3상 MUSETTE 시험이 120주 치료 기간 동안 장애 진행 속도를 늦추는 추가 이점을 보여주는 주요 목표를 달성하지 못했다고 발표했습니다.
연구 결과 현재의 600mg 용량이 최적의 효능을 나타냈으며, 장애 진행 속도는 낮고 이전의 주요 연구와 일치하는 것으로 나타났습니다. 특히 OCREVUS는 3상 RMS 연구에서 관찰된 가장 낮은 연간 재발률을 기록했으며, 재발은 약 16년에 한 번 발생했습니다.
OCREVUS는 미국에서 가장 많이 처방되는 질병 수정 치료제로 자리매김하고 있으며, 전 세계적으로 400,000명 이상의 환자가 치료를 받았습니다. 로슈는 새로운 피하 제형을 통해 치료 접근성을 확대하고 있으며, 편리한 장착 장치 전달을 위한 고농도 제형을 개발하고 있습니다.
Roche (RHHBY) a annoncé que son essai de Phase III MUSETTE, testant une dose plus élevée d'OCREVUS® (ocrelizumab) par rapport à la dose actuelle 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 de l'invalidité sur 120 semaines de traitement.
L'étude a révélé que la dose actuelle de 600 mg a montré une efficacité optimale, avec des taux de progression de l'invalidité restant faibles et cohérents avec des études pivot précédentes. Il est à noter qu'OCREVUS a montré le taux de rechute annualisé le plus bas jamais observé dans une étude de Phase III sur la RMS, avec des rechutes se produisant environ une fois tous les 16 ans.
OCREVUS maintient sa position en tant que thérapie modifiant la maladie la plus prescrite aux États-Unis, avec plus de 400 000 patients traités dans le monde. Roche élargit l'accès au traitement grâce à une nouvelle formulation sous-cutanée et développe une formulation à haute concentration pour une administration pratique via un dispositif portable.
Roche (RHHBY) gab bekannt, dass die Phase-III-Studie MUSETTE, die eine höhere Dosis von OCREVUS® (Ocrelizumab) im Vergleich zur aktuellen Dosis von 600 mg bei schubförmiger Multipler Sklerose (RMS) testete, ihren primären Endpunkt, einen zusätzlichen Nutzen bei der Verlangsamung der Behinderungsprogression über 120 Wochen Behandlung zu zeigen, nicht erreicht hat.
Die Studie ergab, dass die aktuelle Dosis von 600 mg eine optimale Wirksamkeit zeigte, wobei die Raten der Behinderungsprogression niedrig und konsistent mit früheren entscheidenden Studien blieben. Bemerkenswert ist, dass OCREVUS die niedrigste annualisierte Rückfallrate, die jemals in einer Phase-III-RMS-Studie beobachtet wurde, zeigte, wobei Rückfälle etwa alle 16 Jahre auftraten.
OCREVUS behält seine Position als die am häufigsten verschriebene krankheitsmodifizierende Therapie in den Vereinigten Staaten, mit über 400.000 Patienten, die weltweit behandelt wurden. Roche erweitert den Zugang zur Behandlung durch eine neue subkutane Formulierung und entwickelt eine hochkonzentrierte Formulierung für eine bequeme Abgabe über ein tragbares Gerät.
- Current 600 mg dose demonstrated optimal efficacy with low disability progression rates
- Achieved lowest annualized relapse rate ever observed in Phase III RMS studies
- Market leadership position with 400,000+ patients treated globally
- Expanding treatment accessibility through new subcutaneous and high-concentration formulations
- Higher dose failed to show additional benefits in Phase III MUSETTE trial
- 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 the United States with more than 400,000 people treated globally
Basel, 02 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III MUSETTE trial comparing a high dose of OCREVUS® (ocrelizumab) intravenous (IV) infusion to the currently approved OCREVUS IV 600 mg dose in people with relapsing multiple sclerosis (RMS) did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability endpoint over a period of at least 120 weeks of treatment. The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of OCREVUS IV 600 mg. In addition, in several predefined analyses on disease activity, OCREVUS IV 600 mg showed clinically meaningful results with the lowest annualised relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS. The MUSETTE data further support the efficacy and safety profile of the currently approved OCREVUS IV 600 mg dose for RMS.
“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., Roche’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 the United States with more than 400,000 people treated globally. With the recent launch of OCREVUS subcutaneous formulation we aim to improve the treatment experience for people living with multiple sclerosis and expand OCREVUS usage in centres without IV infrastructure or those with IV capacity limitations. In addition, we are developing a novel high concentration formulation for even more convenient on-body device delivery to bring OCREVUS treatment closer to home.
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 the MUSETTE study
MUSETTE (NCT04544436) is a Phase III randomised, double-blind, controlled, parallel-group, multicentre 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 OCREVUS (ocrelizumab)
OCREVUS is a humanised 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 U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, or relapsing secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both OCREVUS IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. OCREVUS SC is given as a single 920 mg subcutaneous injection every six months.
About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. Multiple sclerosis 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 multiple sclerosis 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 multiple sclerosis experience disease progression from the beginning of their disease. Therefore, delays in diagnosis and treatment can negatively impact people with multiple sclerosis, 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 multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.
Approximately
About Roche in Neuroscience
Neuroscience is a major focus of research and development at 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.
Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. 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 Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
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