维布妥昔单抗(Brentuximab Vedotin) - 药物靶点：CD30 x Tubulin_在研适应症：CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma，外周T细胞淋巴瘤，典型霍奇金淋巴瘤_专利_临床

概要

基本信息

药物类型

ADC

别名

Brentuximab、Brentuximab Vedotin (Genetical Recombinatin)、Brentuximab vedotin (genetical recombination) (JAN)

+ [16]

靶点

CD30 x Tubulin

作用机制

CD30抑制剂(肿瘤坏死因子受体超家族成员8抑制剂)、微管蛋白抑制剂

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [3]

在研适应症

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma外周T细胞淋巴瘤典型霍奇金淋巴瘤+ [30]

非在研适应症

急性淋巴细胞白血病急性髓性白血病淋巴母细胞淋巴瘤+ [45]

原研机构

Seagen Inc.

在研机构

Takeda Pharma A/S

Seagen Inc.

Takeda Pharmaceutical Co., Ltd.

+ [7]

非在研机构

Millennium Pharmaceuticals, Inc.

University of Arizona

University of Birmingham

+ [9]

最高研发阶段批准上市

首次获批日期

美国 (2011-08-19),

间变性大细胞淋巴瘤霍奇金淋巴瘤

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)

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结构

分子式C39H67N5O7

InChIKeyDASWEROEPLKSEI-UIJRFTGLSA-N

CAS号474645-27-7

使用我们的XDC技术数据为新药研发加速。

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序列信息

Sequence Code 9923046L

来源: *****

Sequence Code 13006940H

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关联

1,612

项与维布妥昔单抗相关的临床试验

NCT06346899 / Not yet recruitingN/A

The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China

The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.
One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study.

开始日期2024-08-14

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06018935 / RecruitingN/AIIT

A Cohort Establishment Study of Total Management of Ovarian Cancer (Including Fallopian Tube Cancer and Primary Peritoneal Cancer)

A cohort establishment study of total management of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

开始日期2024-06-17

申办/合作机构

四川省肿瘤医院

NCT05381285 / Not yet recruitingN/A

Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period (Survival Model)

Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis

开始日期2024-06-01

申办/合作机构

Cardiff & Vale University Local Health Board

[+1]

100 项与维布妥昔单抗相关的临床结果

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100 项与维布妥昔单抗相关的转化医学

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100 项与维布妥昔单抗相关的专利（医药）

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1,304

项与维布妥昔单抗相关的文献（医药）

2024-03-01·American journal of hematology

Aggressive T‐cell lymphomas: 2024: Updates on diagnosis, risk stratification, and management

Review

作者: Zain, Jasmine M ; Ong, Shin Yeu

Abstract:

Introduction:

Aggressive T‐cell lymphomas continue to have a poor prognosis. There are over 30 different subtypes of peripheral T‐cell lymphoma (PTCL), and we are now beginning to understand the differences between the various subtypes beyond histologic variations.

Molecular Pathogenesis of Various Subtypes of PTCL:

Gene expression profiling and other molecular techniques have enabled deeper understanding of differences in various subtypes as reflected in the latest 5th WHO classification of PTCL. It is becoming increasingly clear that therapeutic approaches that target specific cellular pathways are needed to improve the clinical outcomes of PTCL.

Targeted Therapies:

There are many targeted agents currently in various stages of clinical trials for PTCL that take advantage of the differential expression of specific proteins or receptors in PTCL tumors. This includes the CD30 directed antibody drug conjugate brentuximab vedotin. Other notable targets are phosphatidylinositol 3‐kinase inhibitors, histone deacetylase inhibitors, CD25, and chemokine receptor 4. Anaplastic lymphoma kinase (ALK) inhibitors are promising for ALK expressing tumors.

Immunotherapies:

Allogeneic stem cell transplant continues to be the curative therapy for most aggressive subtypes of PTCL. The use of checkpoint inhibitors in the treatment of PTCL is still controversial, with best results seen in cases of extranodal natural killer cell/T‐cell lymphoma. Bispecific antibody‐based treatments and chimeric antigen receptor cell‐based therapies are in clinical trials.

2024-03-01·Histology and histopathology

Optimizing assessment of CD30 expression in Hodgkin lymphoma by controlling for low expression.

Article

作者: Tome, Margaret E ; Spier, Catherine ; Persky, Daniel ; Sarwar, Shoib ; Billheimer, Dean ; Smith, Catharine L ; Schmelz, Monika

Since the approval of brentuximab vedotin (BV), assessment of CD30 status by immunohistochemistry gained increasing importance in the clinical management of patients diagnosed with CD30-expressing lymphomas, including classical Hodgkin lymphoma (CHL). Paradoxically, patients with low or no CD30 expression respond to BV. This discrepancy may be due to lack of standardization in CD30 staining methods. In this study, we examined 29 cases of CHL and 4 cases of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) for CD30 expression using a staining protocol that was designed to detect low CD30 expression levels, and an evaluation system similar to the Allred scoring system used for breast cancer evaluation. For CHL, 10% of cases had low scores and 3% were CD30 negative, with 3 cases in which the majority of tumor cells showed very weak staining. Unexpectedly, one of four cases of NLPHL was positive. We demonstrate intra-patient heterogeneity in CD30 expression levels and staining patterns in tumor cells. Three CHL cases with weak staining may have been missed without the use of control tissue for low expression. Thus, standardization of CD30 immunohistochemical staining with use of known low-expressing controls may aid in proper CD30 assessment and subsequent therapeutic stratification of patients.

Blood

Current and upcoming treatment approaches to common subtypes of PTCL (PTCL NOS, ALCL, TFHs)

Article

作者: Stuver, Robert N ; Moskowitz, Alison J ; Horwitz, Steven M

Treatment of the common nodal peripheral T-cell lymphomas (PTCLs), which include PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphomas, and T-follicular helper lymphomas, is evolving. These entities are currently treated similarly with CHOP or CHOEP for CD30-negative diseases or brentuximab vedotin plus CHP for CD30-positive diseases, followed by consolidation with autologous stem cell transplant in first remission. Ongoing improvements in PTCL classification, identification of predictive biomarkers, and development of new targeted agents will lead to more specific therapies that address the unique biologic and clinical properties of each entity. For example, widespread efforts focused on molecular profiling of PTCL, NOS is likely to identify distinct subtypes that warrant different treatment approaches. New agents, such as EZH1/2 and JAK/STAT pathway inhibitors, are broadening treatment options for relapsed or refractory disease. Furthermore, promising strategies optimizing immune therapy for PTCL are currently under investigation and have potential to significantly alter the therapeutic landscape. Ongoing front-line study designs incorporate understanding of disease biology and drug sensitivities and are poised to evaluate whether newer targeted agents should be incorporated into the front-line settings for the various disease entities. Although current treatment strategies lump most disease entities together, future treatment will include distinct strategies for each disease subtype that optimizes therapy for individuals. This movement towards individualized therapy will ultimately lead to dramatic improvements in prognosis for patients with PTCL.

435

项与维布妥昔单抗相关的新闻（医药）

2024-06-20

·BioSpace

NIH Finds Non-Chemo Drug Combo Induces Lasting Remission in DLBCL Patients

Pictured: The National Institutes of Health's main building in Maryland/iStock, Grandbrothers Researchers from the National Institutes of Health have identified a novel, non-chemotherapy combination regimen for treating relapsed diffuse large B-cell lymphoma, reporting full remission for some patients no longer responding to standard treatments. Detailing their findings Wednesday in The New England Journal of Medicine, the NIH scientists combined five common anti-cancer agents—AbbVie and Genentech’s Vencelxta (venetoclax), Johnson & Johnson’s Imbruvica (ibrutinib), Genentech’s Gazyva (obinutuzumab), Bristol Myers Squibb’s Revlimid (lenalidomide) and the corticosteroid prednisone. The treatment combo, dubbed ViPOR, was tested in a Phase Ib/II study that included 50 patients with diffuse large B-cell lymphoma (DLBCL). Results showed that the investigational regimen “substantially” shrank tumors in 28 of 48 evaluable patients, according to the NIH. This corresponded to a 54% objective response rate. Overall, 18 patients saw their tumors completely disappear, resulting in a 38% complete response rate for ViPOR. At the end of treatment, circulating tumor DNA was undetectable in 33% of patients. After two years of follow-up, 34% of treated patients showed no signs of the disease while 36% remained alive. In terms of safety, the Phase Ib portion of the study detected a single dose-limiting case of grade 3 intracranial hemorrhage. In the Phase II portion, adverse events of note included grade 3 or 4 neutropenia, thrombocytopenia, anemia and febrile neutropenia. “DLBCL is one of the most genetically heterogeneous forms of cancer, and as a result we don't yet have the ability to identify exactly which combination of drugs would be most effective for any given patient,” Christopher Melani, from the National Cancer Institute’s Center for Cancer Research, said in a statement. Melani co-led the study. “By putting five drugs together, we believe that there will be some drug combination—either two, three, or more drugs—that will be particularly effective against the patient’s tumor,” Melani said. The NIH researchers are working on a larger Phase II study, which they plan to conduct in multiple centers. The mid-stage trial will assess the activity of ViPOR in various genetic subtypes of DLBCL. Accounting for around 25% to 30% of all non-Hodgkin lymphomas, DLBLC is the most common type of lymphoma, according to the NIH. It is typically characterized as the enlargement of lymph nodes or the rapid growth of a mass in a nodal or extranodal site. DLBCL is often aggressive, though it responds reasonably well to a regimen called R-CHOP, which consists of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. Several pharma players are working on potentially better therapies for DLBCL to improve safety and efficacy, as well as provide patients more options in case of disease progression or treatment intolerance. Pfizer is advancing its antibody-drug conjugate Adcetris (brentuximab vedotin) for DLBCL and in March 2024 reported that it significantly improved survival in patients enrolled in the Phase III ECHELON-3 study. Roche is also targeting DLBCL with its bispecific T-cell engager Columvi (glofitamab) boosting survival in the Phase III STARGLO trial, according to an April 2024 readout. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

临床结果临床2期抗体药物偶联物临床3期临床1期

2024-06-14

·药明康德

达完全缓解！潜在“first-in-class” STAT3蛋白降解剂获临床概念验证

▎药明康德内容团队编辑今日，Kymera Therapeutics公布其在研蛋白降解小分子药物KT-333临床1期试验的更新数据。分析显示，KT-333完成初步临床概念验证，在多种血液恶性肿瘤中展示了抗肿瘤活性，包含在两名经典霍奇金淋巴瘤（cHL）患者中达到完全缓解。此次所公布、进行中的1期临床试验旨在评估KT-333在复发和/或难治性淋巴瘤、白血病和实体瘤成人患者中的安全性、耐受性、药代动力学（PK）、药效学（PD）和临床活性。更新数据截至2024年6月3日，包括接受七个剂量水平（DLs）的47名患者，患者平均给药9.1次。这些患者包括cHL、B细胞非霍奇金淋巴瘤、皮肤T细胞淋巴瘤（CTCL）、外周T细胞淋巴瘤（PTCL）、大颗粒淋巴细胞白血病（LGL-L）、T细胞前淋巴细胞白血病（T-PLL）、NK细胞淋巴瘤以及实体瘤患者。主要数据包含：抗肿瘤活性评估： cHL：在DL4水平的三名患者中，两名达到完全缓解。这两名缓解患者在之前至少接受过一种含免疫检查点抑制剂以及抗体偶联药物Adcetris（brentuximab vedotin）的治疗，并随后进行了干细胞移植。此外，在DL6水平的另一名cHL患者中观察到了疾病稳定。 NK细胞淋巴瘤：在DL7水平的STAT3突变患者中达到了完全缓解。 CTCL：在DL2和DL4-6水平的九名患者中，四名达到了部分缓解，另有一名患者在DL4水平观察到疾病稳定。实体瘤：在DL3-4水平的14名患者中，有四名观察到了疾病稳定，包括两例头颈部肿瘤以及胆管癌和肾细胞癌患者。 ▲KT-333试验临床结果摘要（图片来源：参考资料[2]）机制验证和药效 STAT3降解：在DL7水平，KT-333在外周血单核细胞中实现了高达95%的STAT3最大平均降解，并有证据表明STAT3通路受到抑制，和全血中炎症生物标志物的下调。特别是，在DL4水平的CTCL肿瘤活检中，KT-333显著降低了STAT3、pSTAT3和SOCS3的表达。在外周血和肿瘤中均观察到IFN-γ刺激基因特征的诱导：此基因特征预测患者对PD-1类药物的敏感性。这表明患者在接受KT-333治疗后肿瘤微环境中存在良好的免疫调节反应，并支持在实体瘤中，KT-333与PD-1靶向药物形成新组合疗法的潜力。剂量依赖性增加：观察到KT-333血浆暴露水平的剂量依赖性增加，达到了预测的有效水平。 ▲KT-333在外周血单核细胞中实现了高达95%的STAT3最大平均降解（图片来源：参考资料[2]）安全性 KT-333耐受性良好，主要不良事件为1级和2级，包括口腔炎和疲劳。在LGL-L患者中，在DL5水平出现了两例剂量限制性毒性（DLTs），分别为3级口腔炎和关节痛，在DL7水平的淋巴瘤患者中观察到一例3级疲劳。 ▲靶向STAT3的抗肿瘤机制（图片来源：参考资料[2]）KT-333是一种潜在“first-in-class”、强效、高选择性的STAT3靶向小分子降解剂。根据新闻稿，KT-333是靶向未成药转录因子的首个进入临床阶段的降解剂。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Kymera Therapeutics Presents New Clinical Data from the Ongoing Phase 1 Trial of STAT3 Degrader KT-333 at EHA Annual Meeting. Retrieved June 14, 2024 from https://www.globenewswire.com/news-release/2024/06/14/2898896/0/en/Kymera-Therapeutics-Presents-New-Clinical-Data-from-the-Ongoing-Phase-1-Trial-of-STAT3-Degrader-KT-333-at-EHA-Annual-Meeting.html [2] Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of KT-333, a Targeted Protein Degrader of STAT3, in Patients with Relapsed or Refractory Hematologic and Solid Tumor Cancers. Retrieved June 14, 2024 from https://www.kymeratx.com/wp-content/uploads/2024/06/Kymera-Therapeutics-EHA-KT-333-Poster_June-2024.pdf 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床1期临床结果临床终止

2024-06-14

·药明康德

延长难治癌症总生存时间近2倍！罗氏双特异性抗体3期结果公布

▎药明康德内容团队编辑罗氏（Roche）在欧洲血液学协会（EHA）会议上公布其3期试验STARGLO的详细结果。分析显示，与活性对照药物相较，使用其双特异性抗体Columvi（glofitamab）联合吉西他滨和奥沙利铂治疗的复发或难治性（R/R）弥漫性大B细胞淋巴瘤（DLBCL）患者，在总生存期（OS）、无进展生存期（PFS）和完全缓解（CR）率上皆表现出统计学显著且具临床意义的益处。行业媒体Endpoints News指出，该试验数据将提交给监管单位作为glofitamab扩展适应症申请的依据。根据摘要，glofitamab是首个在随机3期试验中表现出DLBCL生存益处的CD3 x CD20靶向双特异性抗体。恶性淋巴瘤分为霍奇金淋巴瘤（HL）和非霍奇金淋巴瘤（NHL）。大B细胞淋巴瘤是NHL的一种，包含了DLBCL、边缘区淋巴瘤（MZL）、原发纵隔大B细胞淋巴瘤（PMBCL）、第3B级滤泡性淋巴瘤（FL3B）等。其中以DLBCL最为常见，每年平均每十万人中有5.6人被诊断有弥漫性大B细胞淋巴瘤，平均每十万人中有1.8人死于此癌症。 STARGLO是一项多中心、开放标签、随机3期研究，旨在评估glofitamab联合吉西他滨加奥沙利铂（Glofit-GemOx）与利妥昔单抗联合奥沙利铂（R-GemOx）相比，对已接受过至少一线治疗且不适合进行自体干细胞移植的DLBCL患者的疗效和安全性。共有274名DLBCL患者入组，患者按2：1的比例随机分配到Glofit-GemOx（8个周期，外加4个周期的glofitamab单药疗法，n=183）或R-GemOx（8个周期，n=91），并根据先前治疗的数量（1 vs ≥2）和对最后一次治疗的耐药性进行分层。主要终点是OS。次要终点包括独立审评委员会（IRC）评估的PFS和CR率。截至2023年3月29日的初步分析显示，Glofit-GemOx与活性对照药物相比具有显著的OS优势（HR：0.59，95% CI：0.40–0.89，p=0.011）。中位随访时间为11.3个月，Glofit-GemOx未达到中位OS（95% CI：13.8-不可评估），而活性对照组为9个月（95% CI：7.3-14.4）。在IRC评估的PFS（HR：0.37，95% CI：0.25-0.55，p<0.0001）和CR率（50.3 vs 22.0%，95% CI：16.3-40.3，p<0.0001）方面也观察到了Glofit-GemOx的显著优势。在所有患者完成治疗后进行了随访分析。截至2024年2月16日，中位随访时间为20.7个月，Glofit-GemOx持续显示出优于活性对照组的中位OS（25.5 vs 12.9个月，HR：0.62，95% CI：0.43–0.88）、中位PFS（13.8 vs 3.6个月，HR：0.40，95% CI：0.28–0.57）和CR率（58.5 vs 25.3%）。 ▲截至2024年2月16日，Glofit-GemOx持续显示出优于活性对照药物的OS益处（图片来源：参考资料[1]） Glofit-GemOx展现良好的耐受性，安全性与每种药物的已知风险一致。由于Glofit-GemOx组的中位治疗周期数高于活性对照组（11 vs 4），在调整患者药物暴露差异后，两组之间的不良事件（AE）发生率相似。在接受glofitamab治疗的患者中，细胞因子释放综合征（CRS）是报告最多的AE（1级：31.4%，2级：10.5%，3级：2.3%）。 Glofitamab是一款能够同时靶向CD3与CD20的双特异性抗体。该T细胞衔接双特异性抗体具有创新的2：1结构形式，包含靶向T细胞表面CD3蛋白的一个蛋白域和与B细胞表面CD20蛋白结合的两个蛋白域，此双重靶向策略可使T细胞靠近B细胞，并活化T细胞以释放癌细胞毒杀蛋白。根据新闻稿，glofitamab是首个获得美国FDA加速批准和欧盟委员会有条件上市的固定时间治疗的双特异性抗体，用于治疗接受过两线或两线以上全身治疗的R/R DLBCL患者。该批准是基于glofitamab作为单药在关键1/2期研究NP30179中所取得的积极结果。分析显示，glofitamab治疗后患者获得持久缓解，总缓解率为56%，完全缓解率为43%，中位缓解持续时间为1.5年。市面上同样靶向CD3 x CD20的双特异性抗体还有艾伯维（AbbVie）和Genmab联合开发的Epkinly（epcoritamab）。该疗法在去年5月获美国FDA加速批准治疗R/R DLBCL患者，包括由惰性淋巴瘤发展而成的DLBCL以及高级别B细胞淋巴瘤（HGBL），这些患者已经接受过两种以上的全身疗法。新闻稿指出，这是首款获FDA批准治疗DLBCL患者的双特异性抗体疗法，该疗法也被行业媒体Evalute认为是潜在的重磅疗法之一。今年2月，两家公司宣布FDA接受epcoritamab的补充生物制品许可申请（sBLA）并授予优先审评资格，用于治疗接受过两次与以上系统性疗法的R/R滤泡性淋巴瘤（FL）成人患者，该申请的PDUFA目标日期为2024年6月28日。除了双特异性抗体，抗体偶联药物（ADC）在DLBCL治疗上也逐渐展现重要性。辉瑞（Pfizer）今年3月宣布其CD30靶向ADC疗法Adcetris（brentuximab vedotin）在3期试验中，与活性对照组相较，显著改善R/R DLBCL患者的OS。2023年4月，罗氏的CD79b靶向ADC疗法Polivy（polatuzumab vedotin）获FDA批准与利妥昔单抗加环磷酰胺、多柔比星和泼尼松（R-CHP）联用，一线治疗DLBCL患者。新闻稿指出，Polivy组合是近20年来FDA批准一线治疗DLBCL的首款新疗法。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] GLOFITAMAB PLUS GEMCITABINE AND OXALIPLATIN (GLOFIT-GEMOX) FOR RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): RESULTS OF A GLOBAL RANDOMIZED PHASE III TRIAL (STARGLO). Retrieved June 14, 2024 from https://library.ehaweb.org/eha/2024/eha2024-congress/4136516/jeremy.abramson.glofitamab.plus.gemcitabine.and.oxaliplatin.28glofit-gemox29.for.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dglofit-gemox [2] Roche details Columvi OS data in quest for expanded lymphoma approval. Retrieved June 14, 2024 from https://endpts.com/eha24-roche-details-overall-survival-data-on-bispecific-antibody-columvi/ [3] Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study. Retrieved June 14, 2024 from https://www.roche.com/media/releases/med-cor-2024-04-15 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床3期临床成功

100 项与维布妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09587	维布妥昔单抗	L01XC12	DB08870

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma	日本	Takeda Pharmaceutical Co., Ltd.	2023-11-24
外周T细胞淋巴瘤	美国	Seagen Inc.	2018-11-16
典型霍奇金淋巴瘤	美国	Seagen Inc.	2017-11-09
蕈样真菌病	美国	Seagen Inc.	2017-11-09
原发性皮肤间变性大细胞淋巴瘤	美国	Seagen Inc.	2017-11-09
CD30阳性外周T细胞淋巴瘤	日本	Takeda Pharmaceutical Co., Ltd.	2014-01-14
CD30阳性霍奇金淋巴瘤	欧盟	Takeda Pharma A/S	2012-10-25
CD30阳性霍奇金淋巴瘤	冰岛	Takeda Pharma A/S	2012-10-25
CD30阳性霍奇金淋巴瘤	列支敦士登	Takeda Pharma A/S	2012-10-25
CD30阳性霍奇金淋巴瘤	挪威	Takeda Pharma A/S	2012-10-25
CD30阳性皮肤T细胞淋巴瘤	欧盟	Takeda Pharma A/S	2012-10-25
CD30阳性皮肤T细胞淋巴瘤	冰岛	Takeda Pharma A/S	2012-10-25
CD30阳性皮肤T细胞淋巴瘤	列支敦士登	Takeda Pharma A/S	2012-10-25
CD30阳性皮肤T细胞淋巴瘤	挪威	Takeda Pharma A/S	2012-10-25
皮肤T细胞淋巴瘤	欧盟	Takeda Pharma A/S	2012-10-25
皮肤T细胞淋巴瘤	冰岛	Takeda Pharma A/S	2012-10-25
皮肤T细胞淋巴瘤	列支敦士登	Takeda Pharma A/S	2012-10-25
皮肤T细胞淋巴瘤	挪威	Takeda Pharma A/S	2012-10-25
复发性间变性大细胞淋巴瘤	欧盟	Takeda Pharma A/S	2012-10-25
复发性间变性大细胞淋巴瘤	冰岛	Takeda Pharma A/S	2012-10-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
CD30阳性淋巴瘤	临床3期	-	Takeda Pharmaceutical Co., Ltd.	2024-01-01
弥漫性大B细胞淋巴瘤	临床3期	-	Takeda Pharmaceutical Co., Ltd.	2024-01-01
复发性弥漫性大B细胞淋巴瘤	临床3期	美国	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	澳大利亚	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	比利时	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	加拿大	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	捷克	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	丹麦	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	法国	Seagen Inc.	2020-08-20
复发性弥漫性大B细胞淋巴瘤	临床3期	德国	Seagen Inc.	2020-08-20

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临床结果

适应症

分期

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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


NCT01716806 (SGN35-015 \| SGN35-015 Part E, CTgov)	临床2期	霍奇金淋巴瘤 \| 外周T细胞淋巴瘤	131	BV+Brentuximab vedotin (BV) (Part A)	壓製夢鏇壓遞築鏇鹹選(膚齋鏇鹹壓簾鏇蓋顧範) = 壓壓觸遞鹹鹽衊願積夢淵醖獵窪衊選鑰積壓廠 (築齋窪鏇窪憲獵膚網膚, 鑰艱範憲願鏇選鑰憲淵 ~ 鹹鏇窪淵網顧廠遞遞齋) 更多	-	2024-06-11
				BV+dacarbazine (Part B)	壓製夢鏇壓遞築鏇鹹選(膚齋鏇鹹壓簾鏇蓋顧範) = 淵憲憲齋鏇壓夢糧範壓淵醖獵窪衊選鑰積壓廠 (築齋窪鏇窪憲獵膚網膚, 築遞顧鹹網醖網醖齋簾 ~ 淵獵窪鬱窪襯鬱顧簾衊) 更多
NCT04404283 (ECHELON-3, ASCO2024) 人工标引	临床3期	弥漫性大B细胞淋巴瘤二线	230	Brentuximab vedotin +Lenalidomide + Rituximab	艱簾齋憲選築獵顧繭醖(蓋鏇獵獵網襯鹹鬱艱齋) = 願獵網衊醖繭觸壓觸齋淵遞鹽獵衊憲獵齋艱觸 (構壓淵廠選繭壓窪繭醖, 10.3 ~ 18.8) 更多	积极	2024-06-02
				Placebo + Lenalidomide + Rituximab	艱簾齋憲選築獵顧繭醖(蓋鏇獵獵網襯鹹鬱艱齋) = 簾網醖廠艱鹹衊齋膚鬱淵遞鹽獵衊憲獵齋艱觸 (構壓淵廠選繭壓窪繭醖, 5.4 ~ 11.7) 更多
NCT01712490 (ECHELON-1, ASCO2024) 人工标引	临床3期	典型霍奇金淋巴瘤一线	-	A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine)	鏇夢獵夢鬱憲壓醖選顧(襯窪獵夢淵顧淵淵餘憲) = 築餘願淵夢顧窪鏇餘網簾廠鑰鹽憲衊蓋積廠窪 (繭鹹積鑰鏇簾簾蓋製願, 91.1 ~ 95.2) 更多	积极	2024-05-24
				ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine)	鏇夢獵夢鬱憲壓醖選顧(襯窪獵夢淵顧淵淵餘憲) = 齋衊淵蓋壓顧鑰餘淵積簾廠鑰鹽憲衊蓋積廠窪 (繭鹹積鑰鏇簾簾蓋製願, 85.8 ~ 91.1) 更多
NCT04569032 (SGN35-032, ASCO2024)	临床2期	外周T细胞淋巴瘤	70	A+CHP	範襯簾艱願膚範鬱製糧(築鑰糧窪選憲襯襯觸鏇) = 膚範鹹鑰網憲範醖簾廠遞鹽艱積夢簾鑰壓築蓋 (製衊積夢夢積憲糧壓繭, 65.3% ~ 86.7%) 更多	积极	2024-05-24
NCT04609566 (SGN35-033, ASCO2024)	临床2期	皮肤黑色素瘤 \| 转移性非小细胞肺癌 CD30	-	Brentuximab vedotin (BV) + Pembrolizumab (pembro)	齋憲艱選壓衊積膚顧膚(鑰遞鏇範簾觸鹹淵糧遞) = 壓膚餘艱艱膚齋顧襯窪選齋製範衊衊齋夢襯糧 (範範齋選鹽鏇遞齋蓋構 )	积极	2024-05-24
NCT02467946 (HALO, EHA2024) 人工标引	临床1/2期	霍奇金淋巴瘤一线	59	BENDAMUSTINE+ADCETRIS	積遞簾夢觸壓顧齋構構(範衊鏇獵顧齋顧壓積醖) = for co-morbidity, showed that (1) 38/54 (70%) had ≥ 5comorbidities, 15 of them (27%) with a score 3 (organ damage). 鹹衊鑰膚簾淵製壓繭築 (艱築膚鬱繭鏇窪製選糧 ) 更多	积极	2024-05-14
EHA2024	N/A	霍奇金淋巴瘤	37	BeGeV + BV therapy	糧遞襯鏇築築範壓遞鑰(網膚鑰醖範醖廠鏇壓繭) = 壓蓋蓋蓋窪餘糧鑰願鏇襯壓網願顧艱蓋願獵範 (憲廠醖襯製憲憲繭鹹壓 ) 更多	积极	2024-05-14
EHA2024	N/A	复发性霍奇金淋巴瘤三线	47	Brentuximab Vedotin + Bendamustine	構願艱繭憲鏇夢製網遞(夢襯衊願壓選構糧憲夢) = only a single patient discontinuing therapy due to G3 peripheral neuropathy in cycle 1 襯獵簾鏇憲醖齋鬱糧願 (淵襯壓顧鏇齋顧膚願鏇 ) 更多	积极	2024-05-14
NCT04378647 (BRESELIBET, EHA2024)	临床2期	复发性经典霍奇金淋巴瘤	160	BRESHAP	襯淵製壓蓋選鑰構廠膚(網鏇齋襯膚齋鏇製鬱鑰) = 糧顧醖願顧簾願選淵繭壓窪鬱膚艱夢艱鬱衊膚 (壓蓋繭醖鬱淵範構獵願 )	积极	2024-05-14
				ESHAP	襯淵製壓蓋選鑰構廠膚(網鏇齋襯膚齋鏇製鬱鑰) = 簾願窪醖糧廠製窪鹹範壓窪鬱膚艱夢艱鬱衊膚 (壓蓋繭醖鬱淵範構獵願 )
EHA2024	N/A	霍奇金淋巴瘤	47	Brentuximab bendamustine	製鹽鑰顧網餘獵鬱範鹽(簾網膚餘鹹壓廠襯範遞) = 遞鬱淵夢糧遞鹽範衊製鑰壓簾繭鏇鹽積獵齋獵 (醖衊遞製鏇齋糧蓋膚製 ) 更多	-	2024-05-14
				ICE chemotherapy	製鹽鑰顧網餘獵鬱範鹽(簾網膚餘鹹壓廠襯範遞) = 蓋鏇艱衊築網願鑰鏇餘鑰壓簾繭鏇鹽積獵齋獵 (醖衊遞製鏇齋糧蓋膚製 ) 更多