达雷妥尤单抗(Daratumumab) - 药物靶点：CD38_在研适应症：免疫球蛋白轻链淀粉样变性，多发性骨髓瘤，阴燃多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Daratumumab (Genetical Recombination)、达雷木单抗、JNJ-54767414

+ [4]

靶点

CD38

作用机制

CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、ADCC(抗体依赖的细胞毒作用)、抗体依赖的细胞吞噬作用

治疗领域

肿瘤免疫系统疾病心血管疾病+ [6]

在研适应症

免疫球蛋白轻链淀粉样变性多发性骨髓瘤阴燃多发性骨髓瘤+ [17]

非在研适应症

结外NK-T细胞淋巴瘤滤泡性淋巴瘤难治性套细胞淋巴瘤+ [8]

原研机构

Janssen Global Services LLC

在研机构

Janssen Research & Development LLCJanssen-Cilag International NVJanssen, Inc.

+ [15]

非在研机构

Janssen-Cilag GmbH

最高研发阶段批准上市

首次获批日期

美国 (2015-11-16),

多发性骨髓瘤

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (英国)、优先审评 (日本)

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序列信息

Sequence Code 9075449L

来源: *****

Sequence Code 9946743H

来源: *****

关联

295

项与达雷妥尤单抗相关的临床试验

NCT06615479 / Not yet recruiting临床3期

A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

开始日期2025-02-15

申办/合作机构

Juno Therapeutics, Inc.

[+1]

NCT06046287 / Recruiting临床2期IIT

Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS

The goal of this clinical trial is to learn about daratumumab and hyaluronidase-fihj in patients with monoclonal gammopathy of undetermined significant (MGUS) who have been diagnosed with peripheral neuropathy suspected to be cause by paraproteinemia. The main question[s] it aims to answer are:
• how well does this medication help improve MGUS associated peripheral neuropathy
Participants will be asked be asked to get some testing done prior to starting the trial in order for us to assess your nerve damage or peripheral neuropathy. This will include blood tests, a complete neurologic examination, surveys and tests called electromyogram and nerve conduction studies. Participants that qualify for the trial will take DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6.

开始日期2024-12-01

申办/合作机构

Georgetown University

[+1]

NCT06570915 / Not yet recruiting临床2期IIT

A Prospective, Single-arm, Multicenter, Open-label , Phase 2 Study to Evaluate Efficacy and Safety of the Daratumumab in T Cell Acute Lymphoblastic Leukemia With Minimal Residual-Positive After Standard Chemotherapy

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Minimal residual disease (MRD) is a strong prognostic indicator for ALL patients. MRD-positive after induction therapy predicts a high risk of relapse. The National Comprehensive Cancer Network (NCCN) considers MRD-positive ALL patients to be at high risk. Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD, which in turn translates into survival benefits. Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells. Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cytophagocytosis (ADCP), and FCγ receptors, which are currently mainly used in the treatment of multiple myeloma. CD38 is highly and stably expressed on the surface of T-ALL cells, and its expression was less influenced by the previous treatment. Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALL(NCT03384654) showed that the effectiveness rate (ORR) was 83.3% in children and 60% in young adults. Compared with the previous historical data, the safety and tolerability were significantly improved. For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate, daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR. These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL. Based on the current difficulties in the treatment of T-ALL and existing research data, we plan to conduct a prospective, single-arm, open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy.

开始日期2024-11-01

申办/合作机构

中国医学科学院血液病医院

100 项与达雷妥尤单抗相关的临床结果

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100 项与达雷妥尤单抗相关的转化医学

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100 项与达雷妥尤单抗相关的专利（医药）

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1,578

项与达雷妥尤单抗相关的文献（医药）

2024-12-31·OncoImmunology

Article

作者: Cartron, Guillaume ; Jacquard, Carine ; Constantinides, Michaël ; Coënon, Loïs ; Robert, Nicolas ; Moreaux, Jérome ; Zemiti, Sara ; Presumey, Jessy ; Gao, Fei ; Campos-Mora, Mauricio ; Villalba, Martin ; Multrier, Caroline

FCGR3A presents a single nucleotide polymorphism at location 158 (V/F), which affects its binding to the fragment crystallizable (Fc) of antibodies (Abs). FcγRIIIa-158 V allotype has the highest affinity and is associated with a better clinical response to IgG1 monoclonal Abs (mAb) treatment. We compared the allele frequency of FCGR3A-F158V polymorphism in cohorts of patients with B-cell lymphoproliferative disorders, including multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), non-Hodgkin lymphoma (NHL), and B-cell chronic leukemia (B-CLL). FCGR3A-158F homozygous were enriched and tended to be in MM and MGUS patients, respectively; but neither in B-CLL nor in NHL patients. We identified a significantly lower concentration of CD8 T-cells and resting memory CD4 T-cells in MM patients bone marrow with the F/F genotype, associated with an increase in the macrophage percentage. In contrast, natural killer cells increased in V/V homozygous patients. This suggests a deregulation of the immune microenvironment in FCGR3A-F/F homozygous patients. However, we did not observe difference in response following treatment combining chemotherapy associated or not with daratumumab, an IgG1 mAb direct against CD38. Our findings suggest that FCGR3A F158V polymorphism can regulate the immune environment and affect the development of tumor plasma cells.

2024-12-31·Cancer biology & therapy

CD46 and CD59 inhibitors enhance complement-dependent cytotoxicity of anti-CD38 monoclonal antibodies daratumumab and isatuximab in multiple myeloma and other B-cell malignancy cells

Article

作者: Gopal, Ajay ; Wang, Hongjie ; Carter, Darrick ; Koob, Theo ; Lieber, André ; Fromm, Jonathan R

Multiple myeloma (MM) is an incurable malignancy of the B-cell lineage. Remarkable progress has been made in the treatment of MM with anti-CD38 monoclonal antibodies such as daratumumab and isatuximab, which can kill MM cells by inducing complement-dependent cytotoxicity (CDC). We showed that the CDC efficacy of daratumumab and isatuximab is limited by membrane complement inhibitors, including CD46 and CD59, which are upregulated in MM cells. We recently developed a small recombinant protein, Ad35K++, which is capable of transiently removing CD46 from the cell surface. We also produced a peptide inhibitor of CD59 (rILYd4). In this study, we tested Ad35K++ and rILYd4 in combination with daratumumab and isatuximab in MM cells as well as in cells from two other B-cell malignancies. We showed that Ad35K++ and rILYd4 increased CDC triggered by daratumumab and isatuximab. The combination of both inhibitors had an additive effect in vitro in primary MM cells as well as in vivo in a mouse xenograft model of MM. Daratumumab and isatuximab treatment of MM lines (without Ad35K++ or rILYd4) resulted in the upregulation of CD46/CD59 and/or survival of CD46^high/CD59^high MM cells that escaped the second round of daratumumab and isatuximab treatment. The escape in the second treatment cycle was prevented by the pretreatment of cells with Ad35K++. Overall, our data demonstrate that Ad35K++ and rILYd4 are efficient co-therapeutics of daratumumab and isatuximab, specifically in multi-cycle treatment regimens, and could be used to improve treatment of multiple myeloma.

2024-12-31·Hematology

Efficacy of daratumumab on multiple myeloma patients with renal insufficiency: a systematic review and meta-analysis

Review

作者: Cui, Canchan ; Guo, Meiyu ; Fu, Weijun ; Mi, Jia ; Li, Meizhang ; Gao, Mingzhao ; Wu, Hao ; Xu, Qianqian ; Li, Lu ; Jiang, Hua ; Chen, Xiaomei

BACKGROUND:

Renal insufficiency (RI) is a key factor affecting the prognosis of multiple myeloma (MM) patients. Because the benefit of daratumumab for treating MM patients with RI remains unclear, our objective was to evaluate the efficacy of daratumumab on MM patients with RI.

METHODS:

We conducted a systematic search of the PubMed, EMBASE, and Cochrane Library databases as of October 24, 2023. Two independent reviewers screened the article titles, abstracts, and full text to identify the randomized controlled trials (RCTs) meeting the inclusion and exclusion criteria. Meta-analyses were performed using RevMan version 5.4. Outcomes of interest were progression-free survival (PFS), overall survival (OS), complete response or better (≥CR), and minimal residual disease (MRD) negativity, all calculated as hazard ratios (HRs) or risk ratios (RRs) with 95% confidence intervals (CIs).

RESULTS:

A total of 10 RCTs with 5003 patients were included. Add-on daratumumab improved PFS and OS among newly diagnosed MM (NDMM) patients with RI (HR 0.48 [95% CI: 0.36, 0.64, I2 = 65%] and HR 0.63 [95% CI: 0.48, 0.82, I2 = 0%]) as well as relapsed/refractory MM (RRMM)-RI patients, compared with the control group (HR 0.46 [95% CI: 0.37, 0.58, I2 = 0%] and HR 0.68 [95% CI: 0.51, 0.92, I2 = 0%]). In terms of the renal status, the efficacy of add-on daratumumab for MMRI patients was similar to that for MM patients with normal renal function. A prolonged PFS benefit for add-on daratumumab treatment versus the control was evident across all RRMM-RI subgroups, and the benefits tended to increase with the follow-up time.

CONCLUSIONS:

Our results indicate that MM patients with RI could benefit from a daratumumab-added regimen regardless of MM status. Additional high-quality RCTs are still warranted to confirm our findings.

896

项与达雷妥尤单抗相关的新闻（医药）

2024-11-15

·药明康德

延长难治性癌症患者生命！ADC疗法3期临床结果积极

▎药明康德内容团队编辑 GSK今日宣布，其抗体偶联药物（ADC）Blenrep（belantamab mafodotin）在3期临床试验DREAMM-7的预定中期分析中获得了积极结果。该试验评估了Blenrep联合硼替佐米和地塞米松（BorDex）作为复发或难治性多发性骨髓瘤的二线或更晚期治疗的效果。试验达到了总生存期（OS）的关键次要终点，显示出Blenrep联合BorDex与标准治疗方案相比，显著降低了患者死亡风险。包括安全性数据在内的中期分析结果将于即将召开的第66届美国血液学会（ASH）年会上发布。在DREAMM-7研究中，患者接受Blenrep联合BorDex，或daratumumab加BorDex的治疗。此前公布的临床试验数据显示，接受Blenrep联合疗法患者（N=243）的中位无进展生存期（PFS）为36.6个月（95% CI：28.4-NR），较活性对照组患者（N=251）的13.4个月（95% CI：11.1-17.5）多了近2年，接受Blenrep联合疗法患者的疾病进展或死亡风险降低了近60%（HR：0.41，95% CI：0.31-0.53，p<0.00001），达成该试验的主要终点。 DREAMM临床开发项目将继续评估Blenrep在治疗更早期患者及其与创新疗法和标准治疗方案联合应用的潜力。除了DREAMM-7，该项目还包括进行中的3期临床试验DREAMM-8，评估Blenrep联合泊马度胺和地塞米松与硼替佐米联合泊马度胺和地塞米松的疗效。作为DREAMM项目的一部分，GSK预计将于2024年年底启动一项针对新确诊但不适合造血干细胞移植的多发性骨髓瘤患者的3期研究。 Blenrep是一种靶向B细胞成熟抗原（BCMA）的抗体偶联药物，由人源化抗BCMA单克隆抗体与细胞毒性载荷auristatin F通过不可切割的连接子结合而成。2024年，基于DREAMM-7和DREAMM-8试验的结果，Blenrep组合疗法已在美国、欧盟、日本、英国、加拿大和瑞士等国家和地区提交了治疗复发或难治性多发性骨髓瘤的上市申请。 ▲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] Blenrep shows overall survival benefit in head-to-head DREAMM-7 phase III trial for relapsed/refractory multiple myeloma. Retrieved November 14, 2024, from https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-overall-survival-benefit-in-head-to-head-dreamm-7-phase-iii-trial-for-relapsedrefractory-multiple-myeloma/ 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3期抗体药物偶联物临床结果临床成功

2024-11-14

·贝壳社

超高潜力赛道迎来曙光

瞪羚社/粽哥又一超高潜力赛道横空出世。强生CD38单抗Darzalex，凭借在多发性骨髓瘤领域大放异彩，以惊人的年销售额逼近百亿美元大关，强势印证了CD38靶点的非凡实力。然而，这只是CD38靶点广阔蓝图中的一抹亮色。继血液瘤之后，CD38靶点正在跨界自免领域，开辟新的蓝海战场。其中，武田制药、渤健/天境生物和康诺亚是迈向新风口的“先行者”。 01 “一超多强”格局 CD38靶点的市场潜力不容小觑，由于其在多发性骨髓瘤细胞上高度表达，成为多发性骨髓瘤抗体治疗的理想靶点。多发性骨髓瘤（MM）是一种克隆浆细胞异常增殖的恶性疾病，全球每年有超过13万例新确诊患者，在许多国家的血液系统恶性肿瘤中排名第二，5年总生存率大约为55%。如今，针对CD38靶点的药物研发正在如火如荼地进行中，涵盖了多种类型，包括单抗、双抗、ADC、CAR-T疗法等。其中，已有2款用于治疗多发性骨髓瘤的CD38单抗获批上市，分别为强生/Genmab的全球首款CD38单抗Darzalex（达雷妥尤单抗）、赛诺菲/ImmunoGen（已被艾伯维收购）的Sarclisa（Isatuximab，艾沙妥昔单抗）。具备先发优势的Darzalex，取得了优异的市场表现：2023年全球销售额高达97.4亿美元，占强生全年总收入的11.4%，2024年上半年销售额继续同比增长18.6%至55.7亿美元。这得益于其在MM领域获批用于多个治疗阶段，覆盖了一线、二线和多线治疗。根据Evaluate预测，Darzalex有望在今年取得近120亿美元的营收，跻身百亿美元俱乐部，并预计2028年销售额达170.22亿美元。VisibleAlpha也预测Darzalex最终销售峰值将达到166亿美元。不过，Darzalex面临着专利悬崖的危机，其在美国、欧洲和日本的组合物专利将于2026年3月到期，目前已有生物类似药在研发当中，例如复宏汉霖HLX15已完成I期临床试验。另一边，赛诺菲/ImmunoGen的Sarclisa正在挑战Darzalex的霸主地位，目前已在50多个国家获批用于治疗多发性骨髓瘤，使得销售额从2020年的1.76亿欧元增长至2023年的3.81亿欧元，今年上半年继续同比增长32%至2.27亿欧元。此外，Sarclisa还在持续拓展适应症，开发计划涵盖MM治疗连续体的六个潜在适应症，以及评估开发皮下给药方法。今年9月，Sarclisa获FDA批准了第3项适应症：联合硼替佐米、来那度胺和地塞米松（VRd）一线治疗不符合自体干细胞移植（ASCT）条件的新诊断多发性骨髓瘤（NDMM），后续有望带来新的增量。 CD38单抗赛道的“后来者”还有不少，渤健/天境生物的Felzartamab（菲泽妥单抗）、武田制药的Mezagitamab等也在加速追赶，形成“一超多强”的市场竞争格局。值得一提的是，CD38单抗的战场不只在多发性骨髓瘤，还有自免领域。 02 自免新蓝海崛起正如本文开头所言，CD38单抗正在拓展至自免领域。这是由于，CD38的表达还与自免疾病有关。 CD38是B细胞尤其是浆细胞表面重要的生物标志物，而异常活化的B细胞及浆细胞是自免疾病的重要致病机制之一，利用靶向CD38抗体清除过度活化的B细胞/浆细胞，可用于治疗自免疾病。目前，武田制药的Mezagitamab（TAK-079）和康诺亚的CM313，均已在免疫性血小板减少症（ITP）的临床研究中展现出积极疗效。而且，Mezagitamab还被开发用于IgA肾病。根据治疗ITP的2b期研究结果显示：在所有三个剂量水平上，Mezagitamab治疗均显著改善了血小板应答，并且在最后一剂治疗后持续 8周直至第16周，展示了Mezagitamab对血小板应答的快速和持久疗效。此前，武田宣布计划在2024财年下半年启动Mezagitamab在ITP患者中的全球性3期临床试验。在肾病治疗领域，最受关注的莫过于渤健重金收购的Felzartamab（菲泽妥单抗）。为了扩大免疫学研发管线，渤健在今年5月宣布以总交易额18亿美元（11.5亿美元预付款+6.5亿美元里程碑付款）收购HI-Bio公司，后者拥有核心资产CD38单抗Felzartamab。 Felzartamab最初由MorphoSys开发，天境生物在2017年引进了该药在大中华区所有适应症的开发和商业化权益，HI-Bio在2022年引进了该药在大中华区以外的全球其他地区所有适应症的权益。渤健通过收购HI-Bio，将Felzartamab纳入囊中。目前，Felzartamab正在开展多项临床研究，适应症包括原发性膜性肾病（PMN）、肾移植术后抗体介导的排斥反应（AMR）、IgA肾病等，其中前2个适应症已完成Ⅱ期研究，IgA肾病的Ⅱ期研究正在进行中。渤健计划在2025年启动针对这3个适应症的Ⅲ期试验。渤健开发主管Priya Singhal医学博士表示，“Felzartamab已经证明了对三种严重未满足需求的肾脏疾病的关键生物标志物和临床终点的影响，是渤健投资组合的战略补充”。正是基于Felzartamab在PMN和AMR适应症上显示出积极疗效，FDA均授予了突破性疗法认定（BTD）和孤儿药资格认定（ODD）。目前，晚期AMR尚无获批疗法，Felzartamab有望成为首个治疗晚期AMR的有效疗法。由此可见，赛诺菲/ImmunoGen（已被艾伯维收购）的Sarclisa同样有治疗自身免疫性肾科领域的潜力，适应症范围还能进一步扩展。如果Sarclisa能斩获肾病适应症，无疑将有更多的筹码挑战强生Darzalex的霸主地位。 03 康诺亚“破局” 视线回到国内市场。如前文所述，天境生物在2017年从MorphoSys公司引进了Felzartamab（菲泽妥单抗）在大中华区的开发和商业化权益。目前，天境生物正在开展菲泽妥单抗联合来那度胺和地塞米松二线治疗多发性骨髓的III期注册性临床研究，此前还在2021年获得国家药监局批准开展治疗系统性红斑狼疮（SLE）的1b期研究。除了天境生物，还有一些国内药企也布局了CD38靶向药物，包括康诺亚、石药集团/友芝友生物、康缘药业、艾森药业，药物类型涵盖了单抗、双抗、ADC和CAR-T疗法。康诺亚自研的CM313，是中国首款获国家药监局临床试验申请批准的国产CD38抗体，目前已开展了多项临床试验，适应症包括多发性骨髓瘤、免疫性血小板减少症（ITP）、系统性红斑狼疮、淋巴瘤。不仅仅是武田制药Mezagitamab，康诺亚CM313也在治疗成人原发免疫性血小板减少症的1/2期临床研究中展现出了积极疗效：CM313在95.5%的既往接受过多种治疗的原发免疫性血小板减少症患者中表现出快速且持续的疗效反应，且安全性良好。这一研究结果发表在了医学顶级期刊《新英格兰医学杂志（NEJM）》上，该研究共入组22例患者，除1例患者首次给药后脱落，其余21例患者均完成了8次给药和16周的随访。21例患者在整个研究期间达到总体缓解（完全或部分缓解），其中20例患者达到完全缓解。大多数患者因CM313治疗后血小板计数恢复正常或安全水平而停用伴随治疗药物。（经CM313治疗，患者的中位血小板计数变化）系统性红斑狼疮与异常活化的B细胞有关，而CD38是这些细胞表面的关键标志物。目前CM313针对系统性红斑狼疮已处于Ib/IIa期临床，有望成为治疗这类疾病的创新型治疗选择。据公开资料显示，系统性红斑狼疮是我国最常见的系统性自身免疫性疾病之一，中国的患者人数超100万，患病率高居世界第二。另外，友芝友生物布局了一款靶向CD3和CD38的双抗药物Y150，目前正在开展针对多发性骨髓瘤的I期临床研究；艾森药业布局了靶向CD38的ADC药物STI-6129，在研适应症包括多发性骨髓瘤、淀粉样变性。除此以外，国内还有一些药企正在探索研发靶向CD38的CAR-T疗法，大多处于临床早期阶段。结语：从血液瘤到自免赛道的差异化探索，CD38靶向药物正展现出新的市场机遇。而且，肾病治疗领域仍是一片未被充分挖掘的蓝海，CD38抗体有望带来更大的想象空间。往期推荐 1 “懂王”之后，接下来看药王的悬念 2 华东医药自免大跃进 _ 3 下一个现象级大药蓄势 _ *声明：本稿件为转载，仅用于分享，不代表本公众号立场，如涉及版权等问题，请尽快联系我们，我们将第一时间更正或删除，谢谢！投稿请添加小助手：bioclub666

免疫疗法抗体药物偶联物细胞疗法专利到期并购

2024-11-14

·EndPoints

GSK makes case for Blenrep's return with new blood cancer survival data

GSK continues to stack up wins to support Blenrep’s comeback, as the company teased new survival data from a late-stage multiple myeloma trial on Thursday. In people with second-line or later relapsed or refractory disease, Blenrep combined with bortezomib and dexamethasone met the overall survival secondary endpoint in the DREAMM-7 trial versus standard of care daratumumab plus bortezomib and dexamethasone, according to a Thursday release . The UK drugmaker is gearing up to relaunch Blenrep in the US in the second half of 2025 after it pulled the drug from the market several years ago in the wake of a failed confirmatory trial in later lines of multiple myeloma. The company has filed data from both the DREAMM-7 and the DREAMM-8 trial of Blenrep combined with pomalidomide plus dexamethasone this year. According to DREAMM-7 topline results in February, the Blenrep regimen slashed the risk of disease progression or death by 59%. At the time, the company only said it had a “meaningful trend” in survival. The new DREAMM-7 data “underscore the potential for this Blenrep combination to extend the lives of patients,” GSK’s head of oncology R&D Hesham Abdullah said in the release. But details of the survival data will have to wait as the company will present them at the American Society of Hematology annual meeting in December. The drugmaker believes Blenrep could reach more than $3 billion in peak sales, mostly driven by the second-line patient population. It is looking to displace Johnson & Johnson’s anti-CD38 monoclonal antibody Darzalex as the second-line standard of care. Meanwhile, GSK plans to start Phase 3 studies comparing Blenrep with Darzalex in first-line multiple myeloma next year. So far this year, GSK has filed Blenrep in the US, Europe, Japan, the UK, Canada and Switzerland. In China, the combination of Blenrep plus bortezomib and dexamethasone has been granted breakthrough therapy designation.

临床3期临床结果突破性疗法ASH会议优先审批

100 项与达雷妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10777	达雷妥尤单抗	L01XC24	DB09331

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
免疫球蛋白轻链淀粉样变性	欧盟	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	冰岛	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	列支敦士登	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	挪威	Janssen-Cilag International NV	2016-05-20
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2015-11-16

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
阴燃多发性骨髓瘤	申请上市	欧盟	Johnson & Johnson	2024-11-08
残留肿瘤	临床3期	美国	Janssen Research & Development LLC	2019-04-26
残留肿瘤	临床3期	加拿大	Janssen Research & Development LLC	2019-04-26
淀粉样变性	临床3期	美国	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	美国	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	日本	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	日本	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	比利时	西安杨森制药有限公司	2017-10-10

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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


AQUILA (ASH2024) 人工标引	临床3期	阴燃多发性骨髓瘤	390	Daratumumab	築餘鏇醖網醖窪築廠壓(醖鹽顧願憲積衊膚淵積) = 範壓鑰壓遞簾鹹顧選夢簾齋淵築壓壓選夢艱膚 (鏇構膚繭鏇繭積窪窪獵 ) 更多	积极	2024-12-09
				Active Monitoring	築餘鏇醖網醖窪築廠壓(醖鹽顧願憲積衊膚淵積) = 鬱繭構鏇淵簾願壓鬱製簾齋淵築壓壓選夢艱膚 (鏇構膚繭鏇繭積窪窪獵 ) 更多
ASH2024	N/A	多发性骨髓瘤	-	Daratumumab (Transplant Eligible (TE) patients)	鬱蓋衊構願艱願顧糧繭(範構艱獵築夢衊鏇廠醖) = 構艱壓淵鏇鏇壓製壓艱醖壓獵淵願選衊鑰夢壓 (遞夢蓋鹹壓齋觸衊製鹽, -6.1 ~ -0.9) 更多	-	2024-12-09
				Daratumumab (Transplant Ineligible (TIE) patients)	鬱蓋衊構願艱願顧糧繭(範構艱獵築夢衊鏇廠醖) = 餘襯遞糧願構淵鏇範遞醖壓獵淵願選衊鑰夢壓 (遞夢蓋鹹壓齋觸衊製鹽, -7.6 ~ -2.1) 更多
ASH2024	N/A	多发性骨髓瘤	-	Daratumumab Plus Lenalidomide (D-R)	願繭衊鏇膚憲鹹廠遞鬱(衊夢鏇選蓋鏇網齋襯壓) = 廠選繭獵觸構窪顧窪鹽築顧憲壓襯齋築觸築衊 (鹹糧繭鏇餘糧襯網遞鑰 ) 更多	-	2024-12-08
				Lenalidomide (R)	願繭衊鏇膚憲鹹廠遞鬱(衊夢鏇選蓋鏇網齋襯壓) = 蓋廠醖衊憲觸糧淵鏇窪築顧憲壓襯齋築觸築衊 (鹹糧繭鏇餘糧襯網遞鑰 ) 更多
ASH2024	N/A	多发性骨髓瘤	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	積鹽壓齋製獵廠鑰憲觸(積齋蓋憲鑰製廠膚簾構) = 繭繭製觸壓醖鹹夢衊醖廠網憲齋鑰淵簾願選範 (襯顧廠願餘鑰鹽淵觸獵 ) 更多	-	2024-12-08
				DVRd-DR	積鹽壓齋製獵廠鑰憲觸(積齋蓋憲鑰製廠膚簾構) = 顧遞窪顧齋壓鹹鬱觸艱廠網憲齋鑰淵簾願選範 (襯顧廠願餘鑰鹽淵觸獵 ) 更多
ASH2024	N/A	多发性骨髓瘤	-	DARA-sensitive patients	壓製獵鑰築廠衊膚糧鏇(網鑰壓構鹽衊繭餘餘鬱) = 淵壓積願願構淵蓋鹹鑰遞衊艱願襯鑰鹽遞膚餘 (遞構廠繭膚構遞膚窪積, 5.5 ~ 9.5) 更多	-	2024-12-07
				DARA-refractory patients	壓製獵鑰築廠衊膚糧鏇(網鑰壓構鹽衊繭餘餘鬱) = 襯願襯築蓋顧餘鬱憲艱遞衊艱願襯鑰鹽遞膚餘 (遞構廠繭膚構遞膚窪積, 3.8 ~ 23.5) 更多
NCT03217812 (OCTANS, Pubmed \| Ann Hematol) 人工标引	临床3期	多发性骨髓瘤一线	215	Daratumumab + Bortezomib + Melphalan + Prednisone	築鏇糧遞鹽衊淵淵鑰衊(齋夢範壓鹽遞壓鏇選醖) = 壓繭願範選網鹹顧獵獵簾糧顧壓構蓋鏇繭簾製 (膚壓壓艱選艱艱繭蓋齋 ) 更多	积极	2024-09-04
				Bortezomib + Melphalan + Prednisone	築鏇糧遞鹽衊淵淵鑰衊(齋夢範壓鹽遞壓鏇選醖) = 鹽襯艱齋鏇廠膚鹹餘鏇簾糧顧壓構蓋鏇繭簾製 (膚壓壓艱選艱艱繭蓋齋 ) 更多
NCT03384654 (DELPHINUS, Pubmed \| Blood) 人工标引	临床2期	急性淋巴细胞白血病 \| 淋巴母细胞淋巴瘤	46	Daratumumab plus backbone chemotherapy (childhood T-cell ALL)	淵壓鬱繭窪遞築構襯製(壓簾憲夢鏇鏇鏇衊鹽鹽) = 夢鑰積顧醖齋蓋獵夢壓襯夢顧選淵鬱築膚製窪 (淵製窪膚餘夢遞顧網艱 ) 更多	积极	2024-08-16
				Daratumumab plus backbone chemotherapy (young adult T-cell ALL)	淵壓鬱繭窪遞築構襯製(壓簾憲夢鏇鏇鏇衊鹽鹽) = 顧淵衊顧齋壓蓋構夢觸襯夢顧選淵鬱築膚製窪 (淵製窪膚餘夢遞顧網艱 ) 更多
NCT04121260 (MMY1010, Pubmed)	临床1期	浆细胞骨髓瘤难治 CD38	21	Subcutaneous daratumumab	衊衊襯壓構築選鏇繭積(壓齋遞網願糧壓餘構鏇) = Incidences of infusion-related reactions were low and consistent with other subcutaneous daratumumab studies 艱範築範淵餘憲淵觸襯 (蓋鬱築獵繭壓網膚艱網 ) 更多	积极	2024-07-01
NCT02541383 (CASSIOPEIA, Pubmed)	临床3期	多发性骨髓瘤	1,085	D-VTd with daratumumab maintenance	艱襯鬱顧構糧淵網艱範(壓簾衊窪膚構夢艱網壓) = 壓壓觸膚襯範觸鹽範鬱築簾遞壓衊廠繭鏇糧獵 (觸鹽簾壓築廠觸廠糧簾, 79.9 ~ NE)	积极	2024-06-14
				VTd with daratumumab maintenance	艱襯鬱顧構糧淵網艱範(壓簾衊窪膚構夢艱網壓) = 網鹹夢製範獵鏇窪鏇醖築簾遞壓衊廠繭鏇糧獵 (觸鹽簾壓築廠觸廠糧簾, 66.9 ~ NE)
NCT04810754 (EULAR2024) 人工标引	临床2期	系统性红斑狼疮	10	Daratumumab 1800mg	積鹽鏇糧願鑰壓製艱鹽(壓構蓋鹹製積艱艱糧鹹) = decreased from a median 166.3 at baseline to 61.1 U/ml at week 12 (p=0.002) 鹽鏇餘網顧鏇顧鬱觸醖 (鬱築衊簾窪築顧製壓憲 ) 更多	积极	2024-06-12