Roche's Subcutaneous OCREVUS One-year Data Demonstrates Near-complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS
Roche's Subcutaneous OCREVUS One-year Data Demonstrates Near-complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks
The twice-yearly, 10-minute SC injection has the potential to expand the usage of OCREVUS to treatment centres without IV infrastructure or with IV capacity limitations
U.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
III 期研究的结果显示，皮下（SC）注射与静脉输注一致，并且在 48 周内几乎完全抑制了复发活动（97%）和 MRI 病变（97.2%）
每年两次、每次10分钟的SC注射有可能将OCREVUS的使用范围扩大到没有静脉输液基础设施或静脉输液能力限制的治疗中心
美国食品和药物管理局根据OCARINA II的数据接受了申请，预计欧盟将在2024年中期获得批准，美国预计在2024年9月获得批准
Basel, 17 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III OCARINA II study (S31.006) of OCREVUS (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation. Treatment with OCREVUS SC led to rapid and sustained B-cell depletion in the blood. The data will be presented as an oral presentation at the 76th American Academy of Neurology (AAN) Annual Meeting taking place April 13-18 in Denver and has been recognised as an abstract of distinction by the AAN scientific committee.
巴塞尔，2024年4月17日——罗氏（SIX：RO，ROG；OTCQX：RHHBY）今天公布了OCREVUS（奥克雷珠单抗）的三期OCARINA II研究（S31.006）的数据，这是一项研究性的，每年两次，每次10分钟的皮下（SC）注射。结果显示，复发或原发性进行性多发性硬化症（RMS或PPMS）患者的临床复发和脑部病变几乎完全得到抑制，这增强了这种研究性制剂的潜在益处。使用OCREVUS SC进行治疗会导致血液中的B细胞快速持续消耗。这些数据将在4月13日至18日在丹佛举行的第76届美国神经病学会（AAN）年会上以口头陈述的形式公布，并已被AAN科学委员会认可为杰出摘要。
"With a full year of data demonstrating near-complete suppression of relapse activity and minimal progression of lesion development, this 10-minute subcutaneous OCREVUS injection shows results that are consistent with the long-established benefits of intravenous OCREVUS," said Levi Garraway, M.D., Ph.D., Roche's chief medical officer and head of Global Product Development. "We look forward to continuing ongoing conversations with regulatory bodies worldwide to potentially bring an additional treatment option to more people living with MS, in a shorter injection time."
罗氏首席医学官兼全球产品开发主管李维·加拉威医学博士说：“整整一年的数据表明，复发活动几乎完全抑制，病变发展进展微乎其微，这种10分钟的皮下OCREVUS注射的效果与静脉注射OCREVUS的长期益处一致。”“我们期待与全球监管机构继续进行对话，以便有可能在更短的注射时间内为更多的多发性硬化症患者提供额外的治疗选择。”
Updated, longer-term results showed that OCREVUS SC injection (920 mg; n=236; both treatment arms [OCR SC/SC and OCR IV/SC]) resulted in near-complete suppression of relapse activity (97.2% had no relapse during the treatment phase) and MRI up to 48 weeks with an ARR of 0.04, and most patients having no T1 gadolinium-enhancing (T1 Gd+) lesions and no new/enlarging T2 lesions. These lesion types are markers of active inflammation and burden of disease, respectively. Additionally, in exploratory patient reported outcome measures (n=52) patients reported a high level of satisfaction (92.3% were satisfied or very satisfied) and convenience (90.1% felt it was convenient or very convenient) with OCREVUS SC injection.
更新的长期结果显示，OCREVUS SC 注射（920 mg；n=236；两个治疗组 [OCR SC/SC 和 OCR IV/SC]）几乎完全抑制了复发活动（97.2% 在治疗阶段没有复发）和长达 48 周的 MRI，ARR 为 0.04，大多数患者没有 T1 镓增强型 (T1 Gd+) 病变，也没有新的/扩大的 T2 病变。这些病变类型分别是活动性炎症和疾病负担的标志。此外，在探索性患者报告的预后衡量标准（n=52）中，患者表示OCREVUS SC注射的满意度很高（92.3％表示满意或非常满意）和便利性（90.1％的人认为很方便或非常方便）。
"Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS," said Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine. "Patients treated with subcutaneous OCREVUS experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity. These results demonstrate the potential of subcutaneous OCREVUS as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals."
约翰·霍普金斯大学医学院主要作者、博士斯科特·纽瑟姆说：“OCARINA II的最新结果进一步突显了皮下OCREVUS对复发和进行性多发性硬化症患者的潜在益处。”“接受皮下OCREVUS治疗的患者经历了适当的B细胞抑制，并对新的炎症性疾病活性进行了令人印象深刻的近乎完全的抑制。这些结果表明，皮下OCREVUS有可能作为一种治疗选择，可以满足多发性硬化症患者和医疗保健专业人员的个人需求。”
Additional data continued to show that the safety profile of OCREVUS SC injection was consistent with the well-established safety profile of OCREVUS IV infusion. No new safety signals were identified for OCREVUS SC. The most common adverse events in the OCREVUS SC group were injection reactions (51.5% of all exposed patients), including erythema (34.8%; skin redness or irritation), pain (17.2%), swelling (9.4%) and pruritus (5.6%; skin itching), all of which were either mild or moderate and none of which led to treatment withdrawal. A total of seven serious AEs were experienced by three (2.6%) and four (3.4%) patients in the OCREVUS SC injection and IV infusion groups, respectively.
其他数据继续显示，OCREVUS SC注射剂的安全性与OCREVUS IV输液的既定安全性一致。OCREVUS SC 没有发现新的安全信号。OCREVUS SC组中最常见的不良事件是注射反应（占所有暴露患者的51.5％），包括红斑（34.8％；皮肤发红或刺激）、疼痛（17.2％）、肿胀（9.4％）和瘙痒（5.6％；皮肤瘙痒），均为轻度或中度，均未导致停止治疗。在OCREVUS SC注射组和静脉输液组中，三名（2.6％）和四名（3.4％）患者共经历了七例严重不良事件。
The OCARINA II abstract was selected as an abstract of distinction by the AAN, based on the quality of the study and the interest to the neurology community.
根据研究质量和神经病学界的兴趣，OCARINA II摘要被AAN选为区分摘要。
The twice-yearly, 10-minute SC injection has the potential to expand the usage of OCREVUS to treatment centres without IV infrastructure or with IV capacity limitations. Data from the Phase III OCARINA II trial were submitted to health authorities around the world following the first presentation of these results during ECTRIMS-ACTRIMS 2023. Both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have accepted Roche's submissions, with a target decision date of mid-2024 for the EMA and September 2024 for the FDA.
每年两次、每次10分钟的SC注射有可能将OCREVUS的使用范围扩大到没有静脉输液基础设施或静脉输液能力限制的治疗中心。在ECTRIMS-ACTRIMS 2023年期间首次公布这些结果后，OCARINA III期三期试验的数据已提交给世界各地的卫生当局。欧洲药品管理局（EMA）和美国食品药品监督管理局（FDA）都接受了罗氏的申请，EMA的目标决定日期为2024年年中，FDA的目标决定日期为2024年9月。
More than 300,000 people with MS have been treated with OCREVUS IV globally. OCREVUS IV is approved in more than 100 countries across North America, South America, the Middle East, Eastern Europe, Asia, Australia, Switzerland, the United Kingdom and the EU.
全球已有超过30万多发性硬化症患者接受了OCREVUS IV治疗。OCREVUS IV 已在北美、南美、中东、东欧、亚洲、澳大利亚、瑞士、英国和欧盟的 100 多个国家获得批准。
Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of MS, further reducing disability progression in RMS and PPMS and improving the treatment experiences for those living with the disease. There are more than 30 ongoing OCREVUS clinical trials designed to help us better understand MS and its progression.
罗氏致力于推进创新的临床研究计划，以扩大对多发性硬化症的科学理解，进一步减少多发性硬化症和PPMS的残疾进展，改善该病患者的治疗体验。目前有30多项OCREVUS临床试验正在进行中，旨在帮助我们更好地了解多发性硬化症及其进展。
About the subcutaneous formulation of OCREVUS (ocrelizumab)
The investigational subcutaneous (SC) formulation combines OCREVUS with Halozyme Therapeutics' Enhanze drug delivery technology.
关于 OCREVUS（奥克雷珠单抗）的皮下制剂
研究中的皮下（SC）配方将OCREVUS与Halozyme Therapeutics的Enhanze药物递送技术相结合。
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 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 是一种人源化单克隆抗体，旨在靶向 CD20 阳性 B 细胞，这是一种特殊类型的免疫细胞，被认为是造成髓磷脂（神经细胞隔热和支持）和轴突的（神经细胞）损伤的关键因素。这种神经细胞损伤可能导致多发性硬化症患者残疾。根据临床前研究，OCREVUS 与某些 B 细胞上表达的 CD20 细胞表面蛋白结合，但不会与干细胞或浆细胞上表达的CD20细胞表面蛋白结合，这表明免疫系统的重要功能可以保留。
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the SC space. This increases the permeability of the tissue under the skin, allowing space for large molecules like OCREVUS to enter, and enables the SC formulation to be rapidly dispersed and absorbed into the bloodstream.
Enhanze药物递送技术基于专有的重组人透明质酸酶PH20（rhUpH20），该酶可在SC空间中局部暂时降解透明质酸（一种糖胺聚糖或体内天然糖链）。这增加了皮肤下组织的渗透性，为 OCREVUS 等大分子留出了进入的空间，并使 SC 配方能够迅速分散并吸收到血液中。
OCREVUS IV is the first and only therapy approved for both 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 PPMS. OCREVUS IV 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 IV是第一种也是唯一一种获准同时用于RMS（包括复发缓解型多发性硬化症 [RRMS] 和活动性或复发性继发性进行性多发性硬化症 [SPMS]，以及美国临床孤立综合征 [CIS]）和PPMS的疗法。OCREVUS IV 每六个月通过静脉输液给药一次。初始剂量为两次 300 mg 的输液，间隔两周。后续剂量以单次 600 mg 输液的形式给出。