VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

开始日期2011-08-01

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT01147393

/ Terminated临床1/2期IIT

Phase I/II Study of Combination Veltuzumab (Anti-CD20) and Fractionated 90Y- Epratuzumab (Anti-CD22) Radioimmunotherapy in Patients With Follicular Lymphoma

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.
The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

开始日期2010-10-01

申办/合作机构

Weill Medical College of Cornell University

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100 项与维妥珠单抗相关的临床结果

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100 项与维妥珠单抗相关的转化医学

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100 项与维妥珠单抗相关的专利（医药）

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项与维妥珠单抗相关的文献（医药）

2025-03-01·Neurology-Neuroimmunology & Neuroinflammation

Alterations in Gut Microbiome-Host Relationships After Immune Perturbation in Patients With Multiple Sclerosis

Article

作者: Hafler, David A. ; Lele, Nikhil ; Cohen, Inessa ; Janda, Guneet S. ; Sung, Jaeyun ; Cruz, Isabella ; Gupta, Vinod K. ; Ruff, William E. ; Longbrake, Erin E. ; Pump, Heather K.

BACKGROUND AND OBJECTIVES:

Gut microbial symbionts have been shown to influence the development of autoimmunity in multiple sclerosis (MS). Emerging research points to an important relationship between the microbial-IgA interface and MS pathophysiology. IgA-secreting B cells are observed in the MS brain, and shifts in gut bacteria-IgA binding have been described in some patients with MS. However, the relationships between the gut microbiome and the host immune response, particularly regarding B-cell-depleting immunomodulation, remain underexplored. This study aimed to evaluate the composition of the gut microbiome in patients with newly diagnosed MS at baseline and after B-cell depletion, using long-read sequencing for enhanced taxonomic resolution. We further aimed to investigate the host/microbiome interface by evaluating microbe/immunoglobulin A relationships.

METHODS:

We collected stool samples from 43 patients with newly diagnosed, untreated MS and 42 matched healthy controls. Nineteen patients with MS initiated anti-CD20 monoclonal antibody treatment and donated additional stool samples after 6 months of treatment. We evaluated the host-microbial interface using bacterial flow cytometry and long-read 16S rRNA gene amplicon sequencing. We used Immune Coating Scores to compare the proportions of bacteria identified in the IgA-coated vs IgA-uncoated bacterial fractions.

RESULTS:

Patients with untreated, newly diagnosed MS showed significant reductions in IgA-bound fecal microbiota compared with controls. Using multiple linear regression models adjusted for potential confounders, we observed significant (p < 0.05) changes in the abundance and prevalence of various strain-level gut bacteria amplicon sequence variants (ASVs) within both total and IgA-coated bacterial fractions. Some changes (e.g., decreased relative abundance of a Faecalibacterium prausnitzii variant in MS) were consistent with previous reports, while others (e.g., increased relative abundance and prevalence of Monoglobus pectinyliticus in MS) were novel. Immune Coating Scores identified subsets of organisms for which normal IgA-coating patterns were disrupted at the onset of MS, as well as those (particularly Akkermansia muciniphila) whose IgA-coating became more aligned with controls after therapy.

DISCUSSION:

This analysis of gut microbial ASVs reveals shifts in taxonomic strains induced by immune modulation in MS.

2025-03-01·Radiology case reports

Rituximab (monoclonal anti-CD20 antibody) induced posterior reversible encephalopathy syndrome (PRES): A case report and literature review

Article

作者: Sukumar, Pujitha Duvooru ; Sharma, Praveen K ; Vikram, Michael Antony ; Balachandar, Sanjaykanth

Posterior reversible encephalopathy syndrome (PRES) is an uncommon neurological condition characterized by reversible subcortical vasogenic edema that primarily affects the posterior areas of the brain. Subcortical vasogenic edema resulting from endothelial injury and hypertension is the pathogenesis. Here, we present a 23-year-old female patient with systemic lupus erythematosus (SLE) and lupus nephritis who developed PRES following Rituximab (a monoclonal anti-CD-20 antibody) administration. The patient initially presented with severe headaches, visual disturbances, and an altered mental status. Neurological examination revealed bilateral cortical blindness, hyperreflexia, and seizures. Brain imaging, including MRI, demonstrated characteristic findings of PRES, with symmetric hyperintensities involving the occipital and parietal lobes on T2-weighted and FLAIR sequences, consistent with vasogenic edema. Rituximab is promptly discontinued, and the patient was managed with supportive care, including antiepileptic drugs and blood pressure control. Within days of Rituximab cessation, the patient showed gradual improvement in symptoms, with resolution of cortical blindness and normalization of MRI findings. Follow-up assessments revealed complete neurological recovery without residual deficits. This instance emphasizes how crucial it is to take into account PRES as a possible side effect in patients receiving Rituximab therapy, especially if those individuals have sudden neurological symptoms. The offending agent must be located and eliminated immediately for the best outcomes. Clinicians should maintain a high index of suspicion for PRES in patients receiving monoclonal anti-CD20 antibody therapies, immunosuppressants, and corticosteroids, facilitating timely diagnosis and intervention to prevent potentially life-threatening complications. More studies are necessary to clarify the pathophysiological mechanisms causing the PRES produced by Rituximab and to improve therapeutic approaches.

2025-02-01·Neurology-Clinical Practice

Impact of Continuous Ofatumumab Exposure During Pregnancy in Multiple Sclerosis

Article

作者: Moser, Tobias ; Otto, Ferdinand ; Hellwig, Kerstin ; Hefner, Simon ; Casaccia, Tiago Lerda ; Hofstaetter, Edda

Objectives:

Anti-CD20 therapies are highly effective treatment options for patients with multiple sclerosis (MS), an inflammatory disorder of the CNS commonly affecting women of childbearing age. Anti-CD20 therapies are however unlicensed for use in pregnancy. Belonging to the IgG1 family, anti-CD20 monoclonal antibodies are likely to cross the placenta, especially after the 20th week of gestation. Our objective was to analyze the impact of ofatumumab (OFA), a subcutaneous anti-CD20 monoclonal antibody, during pregnancy.

Methods:

We present the case of a woman with MS who accidentally administered OFA every 4 weeks until delivery. In addition to detailing the clinical and laboratory outcomes of both mother and child, we provide a summary of the available evidence regarding anti-CD20 treatment during pregnancy and breastfeeding.

Results:

Our patient gave birth to a healthy girl between estimated gestational weeks 32-35. Notably, at 3 months postpartum and 4 months after the last OFA administration, the mother remained fully B-cell depleted while the B-cell counts of the child were within the normal range.

Discussion:

Further data are necessary to confirm that OFA treatment during pregnancy does not affect neonatal B cells.

项与维妥珠单抗相关的新闻（医药）

2025-01-14

·PipelineReview

Bio-Thera Solutions Publishes Phase I Clinical Study Results for BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorders

GUANGZHOU, China I January 14, 2025 I Bio-Thera Solutions, Ltd. today announced the publication of the Phase I clinical study results for BAT4406F , an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody in Chinese patients with neuromyelitis optica spectrum disorders (NMOSD) in the journal CNS Neuroscience & Therapeutics. Neuromyelitis optica spectrum disorder (NMOSD) is a rare immune-mediated central nervous system (CNS) inflammatory demyelinating disease with high recurrence and disability, primarily characterized by severe optic neuritis (ON) and longitudinally extensive transverse myelitis (LETM). ON might result in a decrease in visual acuity, visual field defects, and even blindness. Spinal cord inflammation will also cause paralysis and bladder rectal damage. B-cell depletion therapy by monoclonal antibody (mAb) against CD20 can reduce the recurrence of NMOSD and slow the progression of neurological dysfunction and has a significant therapeutic effect. BAT4406F, a Class 1 innovative drugs developed by Bio-Thera, is a glycosylation-optimized fully anti-CD20 human mAb of IgG1 subclass with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect. In preclinical studies, BAT4406F has showed stronger B-cell depletion activity than the marketed anti-CD20 monoclonal antibodies including rituximab. In this first-in-human, open-label, dose-escalation Phase I clinical study of BAT4406F injection in Chinese NMOSD patients, the overall objective was to assess the tolerability, safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BAT4406F in NMOSD patients. The efficacy of BAT4406F in NMOSD was also preliminarily explored (ClinicalTrials.gov identifier: NCT04146285 ). Five fixed dose groups ranging from 20 mg to 750 mg were set. Fifteen eligible patients were enrolled in this trial and administered with a single intravenous infusion of BAT4406F followed by a 6-month observation period. No subjects experienced DLT at the studied doses. BAT4406F injection has shown favorable safety, with most of the adverse events (AE) of CTCAE Grade 1 or 2 in severity, and no Grade ≥3 adverse drug reactions (ADR) or serious adverse reactions occurred in any subjects. With the dose increase of BAT4406F, C max , AUC 0-t and AUC 0-inf showed an increasing trend, whereas the CL, l Z , and V d decreased. The mean elimination half-life (T 1/2 ) ranged from 9.0-16.4 days. PK profile of BAT4406F was generally nonlinear. BAT4406F led to a rapid and significant B-cell depletion in all dose groups. Single dose of BAT4406F administration maintains B lymphocyte at a low level, and the duration of B lymphocyte suppression and depletion depends on the dose. During the observation period, 13 (86.7%) subjects remained relapse free and 2 (13.3%) subjects relapsed. On day 180 postdose, 100 mg, 500 mg, and 750 mg groups had decreased expanded disability status scale (EDSS) scores compared to baseline. Three subjects were antidrug antibody (ADA) positive and all were neutralizing antibody (NAb)-negative. No obvious effects of ADA positivity on PK, safety, pharmacodynamics, or efficacy were observed. In this study, BAT4406F was well tolerated and showed an expected pharmacodynamic effect of significant and long-term depletion of CD19 + B lymphocytes. BAT4406F also demonstrated preliminary evidence of activity as a NMOSD maintenance treatment. Based on this Phase I study, a Phase II/III multicenter, randomized, double-blind, placebo-controlled trial of BAT4406F in Chinese NMOSD patients is currently undergoing ( NCT06044350 ). About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE / BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter ( @bio_thera_sol ) and WeChat (Bio-Thera). 1. QLETLI ® is a registered trademark of Bio-Thera Solutions, Ltd. 2. POBEVCY ® is a registered trademark of Bio-Thera Solutions, Ltd. 3. BETAGRIN ® is a registered trademark of Bio-Thera Solutions, Ltd. 4. Avzivi ® is a registered trademark of Sandoz AG SOURCE: Bio-Thera Solutions

临床1期临床结果抗体药物偶联物免疫疗法上市批准

2024-11-18

·诺诚健华

诺诚健华宣布奥布替尼多项研究成果入选第66届美国血液学会（ASH）年会

2024年11月18日，中国北京——生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码：09969）今日宣布，新型BTK抑制剂奥布替尼的多项研究成果入选第66届美国血液学协会（ASH）年会，其中包括9个海报展示。本次ASH年会将于2024年12月7-10日在美国加利福尼亚州圣地亚哥举办。海报展示1标题：A Prospective, Multicenter, Single-Arm Study on the Combination of Orelabrutinib and Rituximab in the Second-Line Treatment of Relapsed/Refractory Marginal Zone Lymphoma (Abstract No.: 4391)奥布替尼联合利妥昔单抗二线治疗复发/难治性边缘区淋巴瘤的前瞻性、多中心、单臂研究（摘要代码：4391）分会场：623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III 623. 套细胞、滤泡、华氏巨球蛋白血症和其他惰性B细胞淋巴瘤：临床和流行病学：海报III太平洋时间：2024年12月9日（星期一）下午6:00-8:00 主要作者：欧阳桂芳海报展示2标题：Orelabrutinib in Patients with Indolent Non-Hodgkin Lymphoma (iNHL) Who Are Intolerant to Prior Bruton Tyrosine Kinase Inhibitors (BTKi): Updated Results from a Phase 2 Study (Abstract No.: 4399)奥布替尼治疗对布鲁顿酪氨酸激酶抑制剂（BTKi）不耐受的惰性非霍奇金淋巴瘤（iNHL）患者的2期临床研究最新结果（摘要代码：4399）分会场：623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III 623. 套细胞、滤泡、华氏巨球蛋白血症和其他惰性B细胞淋巴瘤：临床和流行病学：海报III太平洋时间：2024年12月9日（星期一）下午6:00-8:00 主要作者：王黎海报展示3标题：Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study) (Abstract No.: 3244)奥布替尼、氟达拉滨、环磷酰胺联合奥妥珠单抗(OFCG)一线治疗慢性淋巴细胞白血病的多中心、研究者发起的研究（cwCLL-001研究）（摘要代码：3244）分会场：642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II 642.慢性淋巴细胞白血病：临床和流行病学：海报II太平洋时间：2024年12月8日（星期日）下午6:00-8:00 主要作者：李建勇/朱华渊海报展示4标题：Orelabrutinib, Rituximab, and Thiotepa (ORT) in Combination with or without High-Dose Methotrexate in Untreated Primary Central Nervous System Lymphoma (Abstract No.: 4487) 奥布替尼、利妥昔单抗和塞替派（ORT）联合或不联合高剂量甲氨蝶呤治疗初治原发性中枢神经系统淋巴瘤（摘要代码：4487）分会场：627. Aggressive Lymphomas: Pharmacologic Therapies: Poster III 627.侵袭性淋巴瘤：药理学治疗：海报III 太平洋时间：2024年12月9日（星期一）下午6:00-8:00 主要作者：俞文娟海报展示5标题：Preliminary Data of a Single-Arm, Phase II Study of Orelabrutinib with/without Rituximab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma after BTK Inhibitor Therapy (Abstract No.: 3240) 奥布替尼联合或不联合利妥昔单抗治疗经BTK抑制剂治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的单臂II期临床研究的初步数据（摘要代码：3240）分会场：642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II 642.慢性淋巴细胞白血病：临床和流行病学：海报II 太平洋时间：2024年12月8日（星期日）下午6:00-8:00 主要作者：丁凯阳海报展示6标题：Preliminary Data on the Efficacy and Safety of Orelabrutinib Combined with Rituximab and Methotrexate (ORM Regimen) As First-Line Treatment for Primary Central Nervous System Lymphoma, and the Exploration of Cerebrospinal Fluid Ctdna Dynamic Monitoring (Abstract No.: 4500)奥布替尼联合利妥昔单抗和甲氨蝶呤（ORM治疗方案）一线治疗原发性中枢神经系统淋巴瘤的有效性和安全性的初步数据，以及脑脊液Ctdna动态监测的探索（摘要代码：4500）分会场：627. Aggressive Lymphomas: Pharmacologic Therapies: Poster III 627.侵袭性淋巴瘤：药理学治疗：海报III 太平洋时间：2024年12月9日（星期一）下午6:00-8:00 主要作者：欧阳桂芳海报展示7标题：Preliminary Efficacy of Orelabrutinib Targeted Therapy in Induction Therapy of Primary Central Nervous System Diffuse B-Cell Lymphoma (Abstract No.: 4496) 奥布替尼靶向治疗原发性中枢神经系统弥漫性大B细胞淋巴瘤的初步疗效（摘要代码：4496）分会场：627. Aggressive Lymphomas: Pharmacologic Therapies: Poster III 627.侵袭性淋巴瘤：药理学治疗：海报III 太平洋时间：2024年12月9日（星期一）下午6:00-8:00 主要作者：周沙海报展示8标题：The Primary Results of R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) As the First-Line Induction Therapy Followed By Autologous Stem Cell Transplantation in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: 1742) R-MTO方案（利妥昔单抗、甲氨蝶呤、塞替派和奥布替尼）作为一线诱导疗法联合自体干细胞移植治疗初治原发性中枢神经系统淋巴瘤的主要研究结果（摘要代码：1742）分会场：627. Aggressive Lymphomas: Pharmacologic Therapies: Poster I 627.侵袭性淋巴瘤：药理学治疗：海报I 太平洋时间：2024年12月7日（星期六）下午5:30-7:30 主要作者：李增军海报展示9标题：Efficacy and Safety of Orelabrutinib in Relapsed/Refractory Idiopathic Multicentric Castleman Disease: A Single-Center, Retrospective Study (Abstract No.: 1656) 奥布替尼治疗复发/难治性特发性多中心Castleman疾病的疗效和安全性：一项单中心回顾性研究（摘要代码：1656）分会场：623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I 623. 套细胞、滤泡、华氏巨球蛋白血症和其他惰性B细胞淋巴瘤：临床和流行病学：海报I太平洋时间：2024年12月7日（星期六）下午5:30-7:30 主要作者：高雨菡此外，多项研究成果入选了2024 ASH年会的在线发布。1. A Retrospective Analysis of Efficacy and Safety of Orelabrutinib Maintenance in Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma (Abstract No.: 6542)奥布替尼维持治疗初治弥漫性大B细胞淋巴瘤的疗效和安全性的回顾性分析（摘要代码：6542）2. A Retrospective Analysis of Orelabrutinib-Containing Regimen for Marginal Zone Lymphoma (Abstract No.: 6332) 奥布替尼治疗方案治疗边缘区淋巴瘤的回顾性分析（摘要代码：6332）3. Efficacy and Safety of Lenalidomide, PD-1 Monoclonal Antibodies Combined with Orelabrutinib in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Multicenter, Open-Label, Single-Arm, Phase II Study (Abstract No.: 6488) 来那度胺、PD-1单抗联合奥布替尼治疗复发/难治性弥漫性大B细胞淋巴瘤的疗效和安全性：一项多中心、开放标签、单臂、II期临床研究（摘要代码：6488）4. Orelabrutinib-Bruton Tyrosine Kinase Inhibitor-Based Regimens in the Treatment of Marginal Zone Lymphoma: A Retrospective Study (Abstract No.:6308)以布鲁顿酪氨酸激酶抑制剂奥布替尼为基础的治疗方案治疗边缘区淋巴瘤的回顾性研究（摘要代码：6308）5. Pomalidomide, Rituximab, Orelabrutinib, and Minichop-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large-B Cell Lymphoma: Updated Results from a Phase II Study (Abstract No.: 6479) 泊马度胺、利妥昔单抗、奥布替尼联合miniCHOP样（PRO-minichop）方案治疗初治弥漫性大B细胞淋巴瘤老年患者的II期研究最新结果（摘要代码：6479）6. Preliminary Results of a Retrospective Study on a Regimen Based on Orelabrutinib Combined with Anti-CD20 Monoclonal Antibody in Patients with Marginal Zone Lymphoma (Abstract No.: 6293)奥布替尼联合抗CD20单抗治疗边缘区淋巴瘤的回顾性研究的初步结果（摘要代码：6293） 7. Real-World Efficacy and Safety of Orelabrutinib in Marginal Zone Lymphoma: A Retrospective Analysis of Mucosa-Associated Lymphoid Tissue Lymphoma Patients (Abstract No.: 6299)奥布替尼治疗边缘区淋巴瘤的真实世界疗效和安全性：对黏膜相关淋巴组织淋巴瘤患者的回顾性分析（摘要代码：6299） 8. Orelabrutinib with or without Anti-CD20 Monoclonal Antibodies is Highly Effective and Well Tolerated as First-line Therapy for Marginal Zone B cell Lymphoma (Abstract No.: 6541)奥布替尼联合或不联合抗CD20单抗一线治疗边缘区淋巴瘤：高效且耐受性好（摘要代码：6541）9. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab Followed By Orelabrutinib Maintenance Therapy for Untreated Marginal Zone Lymphoma (MZL): A Prospective, Multicenter, Clinical Study (Optimize Study) (Abstract No.: 6280) 奥布替尼联合苯达莫司汀-利妥昔单抗或奥妥珠单抗后序贯奥布替尼维持治疗初治边缘区淋巴瘤（MZL）：一项前瞻性、多中心临床研究（Optimize研究）（摘要代码：6280）10. Practical Application of Orelabrutinib in Patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Analysis of Real-World Evidence (OCARE Study) (Abstract No.: 6772) 奥布替尼在慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者中的实际应用：真实世界分析（OCARE研究）（摘要代码：6772）11. A Retrospective Analysis of the Efficacy and Safety of Orelabrutinib-Containing Regimens in Marginal Zone Lymphoma (Abstract No.: 6282) 奥布替尼治疗方案治疗边缘区淋巴瘤的疗效和安全性的回顾性分析（摘要代码：6282）关于诺诚健华诺诚健华（上交所代码：688428；香港联交所代码：09969）是一家商业化阶段的生物医药高科技公司，专注于恶性肿瘤及自身免疫性疾病领域的一类新药研制。公司现有多个新药产品处于商业化、临床及临床前研发阶段。公司在北京、南京、上海、广州、香港以及美国设有分支机构。

临床2期临床结果临床1期细胞疗法

2024-09-18

·novartis

New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients

Nearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study1 More than 80% of patients receiving first-line Kesimpta were progression-free for up to six years, reinforcing the value of introducing Kesimpta early1 Patients switching to Kesimpta from IV anti-CD20 therapy showed no new active lesions (Gd+ T1) 12 months after switch in separate US single-arm, open-label, Phase IIIb OLIKOS study2 Basel, September 18, 2024 – Novartis today announced new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta® (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from teriflunomide1. A separate US-based single-arm OLIKOS Phase IIIb study showed that at 12 months, all clinically stable RMS patients who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions, a commonly used marker of disease activity, compared to baseline2. These data will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting in Copenhagen, Denmark on September 18-20. “We continue to study the efficacy and safety of Kesimpta in different populations of people living with relapsing multiple sclerosis as part of our mission to advance care,” said Norman Putzki, M.D., Ph.D., Global Development Unit Head, Neuroscience & Gene Therapy, Novartis International AG. “Novartis is committed to understanding and solving some of the most burdensome neurological conditions to improve the quality of life for patients and their caregivers, and to make a positive impact on society.” Kesimpta benefits in first-line patients Data from the overall ALITHIOS study population showed that continuous use of Kesimpta was associated with numerically fewer 6-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) events up to six years compared to those who switched from teriflunomide1. These benefits appeared more pronounced in the RDTN subgroup, defined as starting treatment within three years of diagnosis1. RDTN patients receiving continuous Kesimpta were more likely to remain free from 6mCDW compared to those who switched to Kesimpta from teriflunomide (83.4% vs. 76.3%)1. RDTN patients receiving continuous Kesimpta were also more likely to be free of 6mPIRA vs. switching from teriflunomide (88.9% vs. 83.3%)1. “These data showed that people recently diagnosed with relapsing multiple sclerosis who received first-line Kesimpta had fewer disability worsening events and greater likelihood of being progression-free,” said lead investigator Amit Bar-Or, M.D., Director of the Center for Neuroinflammation and Neurotherapeutics at the University of Pennsylvania. “The reduction of disability accumulation observed early in the disease course supports earlier adoption of Kesimpta.” Limitations of the results include a potential for attrition bias and the open-label nature of the extension study1. No new T1 lesions in patients who switched from IV therapy to KesimptaThe US-based OLIKOS study analyzed 102 clinically stable RMS patients who switched from previous IV anti-CD20 therapy (99% from ocrelizumab) to Kesimpta2. For 84 patients with MRI results, no new Gd+ T1 lesions were observed at 12 months, the study’s primary endpoint. Additionally, 98% of patients did not develop new/enlarging T2 (NeT2) lesions at 12 months, an exploratory endpoint in the study2. Treatment-emergent adverse events (TEAEs) occurred at a similar frequency as in the core Phase III ASCLEPIOS clinical trials, with no new safety signals identified2. The most commonly reported (≥10%) TEAEs were COVID-19, headache, fatigue, and urinary tract infection. Mean serum immunoglobulin G (IgG) and IgM levels remained stable up to 12 months2. About Multiple SclerosisMultiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord3. MS, which affects nearly 3 million people worldwide4, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)5. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease3. About Kesimpta® (ofatumumab)Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously6-9. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional6,7. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen10. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 201511. Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 90 countries worldwide with more than 100,000 patients treated as of August 20246,7,12. Novartis in NeuroscienceAt Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, pediatric neurology, neurodegeneration and neuroinflammation and psychiatry. DisclaimerThis media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise. About NovartisNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Bar-Or A, Hauser SL, Cohen JA, et al. Early Initiation of Ofatumumab Delays Disability Progression in People With Relapsing Multiple Sclerosis: 6-Year Results From ALITHIOS Open-Label Extension Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting; September 18–20, 2024; Copenhagen, Denmark. Hua LH, Brown B, Camacho E, et al. Efficacy and Safety in Patients With Relapsing Multiple Sclerosis Who Switched to Subcutaneous Ofatumumab From Intravenous Anti-CD20 Therapies: Results From the OLIKOS Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting; September 18–20, 2024; Copenhagen, Denmark. Guthrie E. Multiple sclerosis: A primer and update. Adv Studies Pharm. 2007;4(11):313-317. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977. National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS Accessed September 10, 2024 Kesimpta. Prescribing Information. Novartis Pharmaceuticals Corporation East Hanover. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl… Accessed September 11, 2024. Kesimpta. Summary of Product Characteristics. Novartis Ireland Limited. 2023. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf Accessed June 23, 2024. Hauser SL, Kappos L, Bar-Or A, et al. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol Ther. 2023;12(5):1491-1515. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Annual Forum; February 27–29, 2020; West Palm Beach, FL, US. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting 2016; September 14–17, 2016; London, UK. Genmab. Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Available from: https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d Accessed September 10, 2024. Novartis. Data on file. Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414 Anna Schäfers +41 79 801 7267 Switzerland Satoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck +41 61 324 7188 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 3809 Jonathan Graham +1 201 602 9921 Imke Kappes +41 61 324 8269 Parag Mahanti +1 973 876 4912

临床结果临床3期上市批准

100 项与维妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09031	维妥珠单抗	-	DB05656

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	加拿大	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	捷克	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	德国	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	意大利	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	墨西哥	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	波兰	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	西班牙	Takeda Pharmaceutical Co., Ltd.	2011-08-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ECTRIMS2023	N/A	复发-缓解型多发性硬化	-	anti-CD20 monoclonal antibody (Treatment-naïve RRMS)	遞繭蓋範範構繭齋願齋(顧壓淵築醖願鏇廠衊鏇) = 廠範網製觸繭網襯積網夢網襯糧選窪膚遞遞鹽 (鑰築遞繭齋醖構憲夢繭 )	积极	2023-09-30
				anti-CD20 monoclonal antibody (RRMS treated with ocrelizumab or rituximab for 6 months)	遞繭蓋範範構繭齋願齋(顧壓淵築醖願鏇廠衊鏇) = 衊淵齋網鹹積鹹鏇鑰簾夢網襯糧選窪膚遞遞鹽 (鑰築遞繭齋醖構憲夢繭 )
ECTRIMS2022	N/A	复发-缓解型多发性硬化 CD20	-	Anti-CD20 mAb treated patients with RRMS	壓網醖築衊蓋衊顧範糧(鬱憲鹹鏇鬱獵艱範簾糧) = 積鏇積遞製網艱顧繭鏇鏇觸鹹廠淵衊鏇鑰餘齋 (廠夢鑰獵艱夢鏇窪餘窪 ) 更多	-	2022-10-12
				anti-CD20 monoclonal antibody (Treatment naïve patients with RRMS)	壓網醖築衊蓋衊顧範糧(鬱憲鹹鏇鬱獵艱範簾糧) = 鑰觸窪膚願鏇蓋鬱壓網鏇觸鹹廠淵衊鏇鑰餘齋 (廠夢鑰獵艱夢鏇窪餘窪 ) 更多
ECTRIMS2022	N/A	anti-CD20 IgG1 monoclonal antibodies	57	Ocrelizumab 300mg	築獵襯獵蓋鏇鑰範襯窪(齋鏇糧糧憲簾選鏇齋範) = 廠繭鑰糧衊壓夢鹹艱鏇繭襯鏇艱廠衊壓淵鏇鬱 (壓憲範齋鑰選鹹鏇糧獵 ) 更多	积极	2022-10-12
				Ocrelizumab 600mg	築獵襯獵蓋鏇鑰範襯窪(齋鏇糧糧憲簾選鏇齋範) = 獵積鹹憲糧願簾鬱糧選繭襯鏇艱廠衊壓淵鏇鬱 (壓憲範齋鑰選鹹鏇糧獵 ) 更多
ACTRIMS2020	N/A	-	-	anti-CD20 monoclonal antibody (RT-PCR)	衊膚繭獵壓積壓餘窪鬱(蓋廠顧夢鬱獵遞衊繭鹹) = 壓網鹹膚鬱齋鹹鏇齋廠觸構鑰觸醖鑰糧艱鹽願 (膚觸構鹽獵壓獵築衊築 ) 更多	-	2020-05-11
				anti-CD20 monoclonal antibody (Flow Cytometry)	衊膚繭獵壓積壓餘窪鬱(蓋廠顧夢鬱獵遞衊繭鹹) = 窪鏇襯鏇範齋糧醖壓觸觸構鑰觸醖鑰糧艱鹽願 (膚觸構鹽獵壓獵築衊築 ) 更多
FP208 (ERA2019)	N/A	抗中性粒细胞胞质抗体相关性血管炎	242	Mabthera	觸選衊齋鑰簾選選築壓(繭網淵鏇衊鏇築簾糧淵) = One episode of anaphylaxis was reported with Mabthera 糧齋觸鏇積壓觸願齋構 (繭夢築鹽築觸顧製鹹網 ) 更多	积极	2019-06-13
				Truxima
NCT00547066 (Pubmed \| Haematologica) 人工标引	临床1/2期	免疫性血小板减少症 CD20 Positive	50	Veltuzumab	構蓋繭餘艱壓餘簾繭餘(壓鏇構膚觸鑰膚獵鬱膚) = transient，mild to moderate 製衊築顧鹹醖遞鏇壓遞 (鑰獵積餘願膚遞淵淵繭 )	积极	2016-11-01
NCT00546793 (Pubmed \| Leukemia \| Leuk Lymphoma) 人工标引	临床1期	慢性淋巴细胞白血病	21	veltuzumab	艱鬱鹹簾鏇選築簾衊糧(遞壓鑰齋窪窪蓋鹽窪觸) = 衊獵願鏇淵製顧膚憲簾獵醖廠齋觸鑰齋選憲衊 (觸襯壓積鬱鹽艱糧遞積 ) 更多	积极	2016-01-01
NCT00989586 (Pubmed \| Int J Radiat Oncol Biol Phys \| Br J Haematol) 人工标引	临床1/2期	B细胞淋巴瘤	35	milatuzumab+veltuzumab	獵願顧廠夢製鑰顧齋顧(窪糧構願壓觸蓋鏇餘獵) = 夢襯膚鏇網築鬱範艱觸醖窪網製衊繭夢襯淵膚 (糧糧夢鬱衊餘窪鹽範糧 ) 更多	积极	2015-06-01
				Veltuzumab 200 mg/m(2) weekly + Milatuzumab 16 mg/kg weekly	-
ASCO2008	临床1/2期	淋巴瘤	-	Veltuzumab	鑰蓋願憲廠鏇艱衊壓廠(齋願鬱憲膚鑰願築餘蓋) = 鏇獵蓋鹹繭壓糧膚艱願願鑰範鏇膚艱觸壓廠築 (獵遞製夢範築獵積鑰鹹 ) 更多	-	2008-05-20
ASCO2006	临床1/2期	非霍奇金淋巴瘤	-	IMMU-106 (hA20) 120 mg/m^2	糧廠齋簾壓觸製膚鹹蓋(蓋繭簾衊觸觸鏇憲醖遞) = 鏇製壓淵糧築獵構願簾築積觸襯範膚憲遞憲蓋 (壓網顧廠觸獵廠選糧艱 ) 更多	-	2006-06-20