Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III MUSETTE trial comparing a high dose of Ocrevus

基因泰克（Genentech），罗氏集团（SIX：RO，ROG；OTCQX：RHHBY）的成员，今天宣布了三期MUSETTE试验的高剂量Ocrevus对比结果。

(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.

在复发性多发性硬化症（RMS）患者中，将（ocrelizumab）静脉（IV）输注与目前批准的Ocrevus IV 600 mg剂量进行比较，在至少120周的治疗期间，通过综合残疾终点测量，未达到其主要终点，未能显示出延缓残疾进展的额外益处。

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 annualized relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS.

残疾进展率较低，与之前Ocrevus IV 600 mg的关键研究中观察到的进展率一致。此外，在几项针对疾病活动的预设分析中，Ocrevus IV 600 mg在复发缓解型多发性硬化症（RMS）的III期研究双盲阶段显示出具有临床意义的结果，其年化复发率（ARR）为最低。

The MUSETTE data further support the efficacy and safety profile of the currently approved Ocrevus IV 600 mg dose for RMS..

MUSETTE 数据进一步支持了目前批准的 Ocrevus IV 600 毫克剂量对 RMS 的有效性和安全性。

“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.

“Ocrevus是首个且唯一获批用于治疗RMS和PPMS的B细胞疗法，在超过十年的治疗中，大多数RMS患者仍然没有出现疾病进展，”基因泰克首席医学官兼全球产品开发负责人Levi Garraway博士表示。“这些研究结果再次证实，目前Ocrevus静脉注射600毫克的剂量能够显著减缓残疾进展，是最优的剂量。”

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.’’ .

此外，在几项关于疾病活动的预定义分析中，奥克雷珠单抗在复发方面显示出具有临床意义的结果，复发大约每16年发生一次，这是抗CD20 RMS药物的首次突破。

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 Zunovo™, we aim to improve the treatment experience for people living with multiple sclerosis and expand Ocrevus usage in centers without IV infrastructure or those with IV capacity limitations.

自推出以来，Ocrevus 在多发性硬化症（MS）治疗中树立了新的标准，是美国处方量最大的疾病修正疗法，全球已有超过 40 万人接受治疗。随着 Ocrevus Zunovo™ 的近期上市，我们的目标是改善多发性硬化症患者治疗体验，并在没有静脉输液设施或静脉输液能力有限的中心拓展 Ocrevus 的使用。

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. .

此外，我们正在开发一种新型高浓度制剂，以实现更便捷的贴身设备递送，让Ocrevus治疗更加贴近家庭。

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). .

除了奥瑞珠单抗，罗氏还拥有多种配方和靶点的多样化且前景广阔的研发管线，例如Brainshuttle™ CD20、处于早期开发阶段的单酰甘油脂肪酶（MAGL）抑制剂，以及正在针对复发缓解型多发性硬化症（RMS）和原发进展型多发性硬化症（PPMS）进行III期研究的布鲁顿酪氨酸激酶（BTK）抑制剂芬布替尼（fenebrutinib）。

Full data from MUSETTE will be presented at an upcoming medical meeting.

MUSETTE 的完整数据将在即将召开的医学会议上公布。

About Ocrevus

关于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.

Ocrevus是一种人源化单克隆抗体，旨在靶向CD20阳性B细胞，这是一种特定类型的免疫细胞，被认为是对髓鞘（神经细胞的绝缘和支持）和轴突（神经细胞）损伤的主要贡献者。这种神经细胞损伤可能导致多发性硬化症患者的残疾。

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. .

基于临床前研究，Ocrevus 能与某些 B 细胞（而不是干细胞或浆细胞）表达的 CD20 细胞表面蛋白结合，这表明免疫系统的重要功能可能会得以保留。

Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo

奥克雷武斯静脉注射和奥克雷武斯皮下注射（SC；市场名称为奥克雷武斯祖诺沃）

[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).

[ocrelizumab hyaluronidase-ocsq]在美国是唯一获批用于治疗RMS（包括复发缓解型多发性硬化症[RRMS]、活动性或复发性继发进展型多发性硬化症[SPMS]，以及美国的临床孤立综合征[CIS]）和原发进展型多发性硬化症（PPMS）的疗法。

Both Ocrevus IV and Ocrevus Zunovo 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 Zunovo is given as a single 920 mg subcutaneous injection every six months. .

Ocrevus IV和Ocrevus Zunovo每六个月给药一次。初始IV剂量分两次300 mg输注，间隔两周，随后的剂量为单次600 mg输注。Ocrevus Zunovo每六个月进行一次单次920 mg皮下注射。

About the MUSETTE study

关于MUSETTE研究

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.

MUSETTE（NCT04544436）是一项III期随机、双盲、对照、平行组、多中心试验，旨在评估高剂量Ocrevus静脉（IV）输注（体重<75公斤的患者为1,200毫克，体重≥75公斤的患者为1,800毫克）与目前获批的Ocrevus IV 600毫克剂量相比，在复发缓解型多发性硬化症（RMS）成年患者中的疗效、安全性和药代动力学。

Patients received treatment with Ocrevus high dose or IV 600 mg every 24 weeks for a minimum of 120 weeks..

患者每24周接受高剂量Ocrevus或静脉注射600毫克的治疗，持续至少120周。

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 ≥20% increase in time to perform the timed 25-foot walk (T25FW); a ≥20% increase in time to perform the nine-hole peg test (9HPT). .

主要终点是首次出现12周复合确认残疾进展（cCDP）的时间，定义为以下任何事件持续12周：如果基线扩展残疾状态量表（EDSS）评分≤5.5，则EDSS评分从基线增加≥1.0分；如果基线EDSS评分>5.5，则增加≥0.5分；完成25英尺步行测试（T25FW）时间增加≥20%；完成九孔钉测试（9HPT）时间增加≥20%。

About multiple sclerosis

关于多发性硬化症

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.

多发性硬化症 (MS) 是一种慢性疾病，影响全球超过 290 万人。当免疫系统异常攻击中枢神经系统（大脑、脊髓和视神经）中神经细胞的绝缘层和支持结构（髓鞘）时，就会发生 MS，从而引发炎症并导致损害。

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..

这种损害可能导致各种各样的症状，包括虚弱、疲劳和视力困难，并最终可能导致残疾。大多数多发性硬化症患者在20至40岁之间出现第一个症状，这使得该疾病成为年轻成年人获得性非创伤性残疾的主要原因。

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.

所有形式的多发性硬化症患者从发病初期就会经历疾病进展——即中枢神经系统中神经细胞的永久性丧失——即使他们的症状不明显或似乎没有恶化。诊断和治疗的延误会对多发性硬化症患者的身心健康产生负面影响，并对个人和社会造成负面的经济影响。

An important goal of treating MS is to slow, stop and ideally prevent progression as early as possible..

治疗多发性硬化症的一个重要目标是尽可能早地减缓、停止并理想地防止病情进展。

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.

复发缓解型多发性硬化症（RRMS）是最常见的疾病形式，其特征是出现新的或恶化的症状（复发）的发作，随后是恢复期。大约85%的多发性硬化症患者最初被诊断为RRMS。大多数被诊断为RRMS的人最终会转变为继发进展型多发性硬化症（SPMS），在这种类型中，他们会随着时间的推移经历持续加重的残疾。

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.

多发性硬化症的复发形式（RMS）包括患有复发缓解型多发性硬化症（RRMS）的人，以及继续经历复发的继发进展型多发性硬化症（SPMS）患者。原发进展型多发性硬化症（PPMS）是一种致残性的疾病形式，其特征是症状持续恶化，但通常没有明显的复发或缓解期。大约15%的多发性硬化症患者被诊断为原发进展型。

Until the FDA approval of Ocrevus intravenous (IV) infusion, there had been no FDA-approved treatments for PPMS and Ocrevus IV and Ocrevus Zunovo are the only approved treatments for PPMS..

在FDA批准Ocrevus静脉（IV）输注之前，尚无FDA批准的针对PPMS的治疗方法，而Ocrevus IV和Ocrevus Zunovo是唯一获批用于PPMS的治疗药物。

About Genentech in neuroscience

关于基因泰克在神经科学领域

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.

神经科学是基因泰克和罗氏研究与开发的重点领域。我们的目标是追求开创性的科学，开发新的治疗方法，帮助改善慢性病和潜在毁灭性疾病患者的生活。

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..

基因泰克和罗氏正在研究十几种治疗神经系统疾病的药物，包括多发性硬化症、中风、阿尔茨海默病、亨廷顿病、帕金森病、杜氏肌营养不良症和自闭症谱系障碍。我们与合作伙伴一起，致力于推动科学理解的边界，以解决当今神经科学领域中最艰巨的挑战。

About Genentech Access Solutions

关于Genentech访问解决方案

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 the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine.

Access Solutions 是 Genentech 致力于帮助人们获得其处方的 Genentech 药品的承诺的一部分，无论其支付能力如何。Access Solutions 的内部专家团队专注于帮助人们解决药品获取和报销流程问题，并为美国符合条件的无保险或无法承担自付药费的患者提供援助。

About Genentech

关于基因泰克

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.

成立于40多年前的基因泰克是一家领先的生物技术公司，致力于发现、开发、生产及销售用于治疗严重和危及生命的疾病的药物。该公司隶属于罗氏集团，总部位于加利福尼亚州南旧金山。