泰朗妥昔单抗(Loncastuximab tesirine) - 药物靶点：CD19 x DNA_在研适应症：复发性弥漫性大B细胞淋巴瘤，难治性弥漫性大B细胞淋巴瘤活化B细胞型，弥漫性大B细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

ADC

别名

Anti-CD19-PBD-conjugate-ADC、Immunoglobulin g1-kappa, anti-(homo sapiens b-lymphocyte antigen cd-19)chimeric monoclonal antibody conjugated to an average of two molecules of tesirine.gamma.1 heavy chain (1-449) (mus musculus vh (ighv1-69*02 (86%) (ighd)-ighj4*01)) (8.8.13) (1-120) -、Lonca

+ [10]

靶点

CD19 x DNA

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、DNA调节剂(DNA调节剂)、DNA烷化剂

+ [1]

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

复发性弥漫性大B细胞淋巴瘤难治性弥漫性大B细胞淋巴瘤活化B细胞型弥漫性大B细胞淋巴瘤+ [14]

非在研适应症

伯基特淋巴瘤套细胞淋巴瘤纵隔大b细胞淋巴瘤+ [4]

原研机构

ADC Therapeutics SA

在研机构

ADC Therapeutics SA

Swedish Orphan Biovitrum AB

瓴路药业（上海）有限责任公司初创企业

+ [2]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2021-04-23),

弥漫性大B细胞淋巴瘤高级别B细胞淋巴瘤

最高研发阶段(中国)申请上市

特殊审评加速审评 (美国)、附条件批准 (欧盟)、孤儿药 (欧盟)、优先审评 (中国)、加速批准 (美国)

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结构

分子式C42H65N5O17

InChIKeyNPTPHNNPPOZTSM-GSSDHLSPSA-N

CAS号-

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使用我们的ADC技术数据为新药研发加速。

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序列信息

Sequence Code 315596551H

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Sequence Code 315596552L

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关联

32

项与泰朗妥昔单抗相关的临床试验

NCT06607549 / Not yet recruiting临床1期IIT

A Phase 1 Study of Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery (SRS) in Patients With Primary and Secondary Central Nervous System Lymphomas

The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.

开始日期2024-11-01

申办/合作机构

University of Utah

[+1]

NCT05991388 / Recruiting临床2/3期IIT

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people.
The Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine.
Experts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available.
Children from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.

开始日期2024-05-02

申办/合作机构

University of Birmingham

[+3]

NCT05672251 / Recruiting临床2期IIT

A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.

开始日期2024-01-02

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与泰朗妥昔单抗相关的临床结果

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100 项与泰朗妥昔单抗相关的转化医学

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100 项与泰朗妥昔单抗相关的专利（医药）

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67

项与泰朗妥昔单抗相关的文献（医药）

2024-11-01·JAAD Case Reports

Vesiculobullous eruption with loncastuximab tesirine in a patient with relapsed follicular lymphoma

Article

作者: Hornick, Noah I ; Hornick, Noah I. ; Okada, Craig Y. ; Okada, Craig Y ; Seervai, Riyad N.H. ; Seervai, Riyad N H ; Mengden-Koon, Stephanie J. ; Mengden-Koon, Stephanie J

2024-10-01·eJHaem

Real‐world treatment of large B‐cell lymphoma with chimeric antigen receptor T‐cell therapy after loncastuximab tesirine

作者: DeVos, Jakob D ; Chen, Lei ; Lucero, Melanie ; Hamadani, Mehdi

2024-09-29·Cureus

Treatment of Secondary Hemophagocytic Lymphohistiocytosis Associated With Diffuse Large B-cell Lymphoma Using Loncastuximab Tesirine As Lymphoma-Directed Therapy

Article

作者: Schieber, Timothy ; Snyder, Jordan ; Lutfi, Forat

Three critically ill, chemotherapy-refractory patients with diffuse large B-cell lymphoma (DLBCL) received loncastuximab tesirine in conjunction with standard therapies for secondary malignancy-associated hemophagocytic lymphohistiocytosis (Mal-HLH). All patients were treated inpatient, with one requiring intubation on the day of administration. Each patient had an H-score >238, indicating a >98% probability of HLH. A significant reduction in ferritin levels was observed in two patients, and one patient achieved a complete response (CR). Loncastuximab tesirine demonstrated promise in managing Mal-HLH where previous treatments had failed. This study suggests that loncastuximab tesirine exhibits favorable activity and should be considered a valuable addition to the treatment options for Mal-HLH driven by DLBCL.

284

项与泰朗妥昔单抗相关的新闻（医药）

2024-11-19

·生物制药小编

ADC70载，风华正茂。

1958 年Mathe等首次将甲氨蝶呤偶联抗鼠免疫球蛋白治疗白血病，拉开了 ADC 药物的研究序幕,至今已近70载。 Mathe G, Tran Ba LO and Bernard J. Effect on mouse leukemia 1210 of a combination by diazoreaction of amethopterin and gamma-globulins from hamsters inoculated with such leukemia by heterografts. C R Hebd Seances Acad Sci 1958; 246: 1626–1628. 1913年保罗·埃利希(Paul Ehrlich)为代表的科学家们首次提出ADC概念。 ADCs 的结构（一）单克隆抗体结构与功能所有抗体都有基本结构，由两条重链和两条轻链组成，通过链间和链内二硫键及非共价作用组装成 Y 形结构。重链上的短碳水化合物链增强水溶性，铰链区使抗体适应抗原排列。单克隆抗体是 ADCs 的主要成分，能特异性结合肿瘤细胞表面抗原，将细胞毒性药物运输到作用靶点。发展历程早期使用的鼠源抗体因免疫原性问题，逐渐被嵌合、人源化或全人源抗体替代，后者免疫原性显著降低。常用的 IgG 亚型中，IgG1 半衰期长，具有多种效应功能，如抗体依赖性细胞介导的细胞毒性等，是 ADCs 中常用的亚型，但 IgG3 因清除率快较少使用。为改善在肿瘤组织中的扩散，设计 ADCs 时会考虑减小抗体尺寸，如去除 Fc 段。（二）连接子功能与特性连接子将抗体与细胞毒性药物连接，在血液循环中需保持稳定，防止药物过早释放，同时在肿瘤细胞内要能有效释放药物。它还应确保抗体的结合特异性不受影响，并保证 ADC 的良好溶解性。分类及特点主要为硫醚或马来酰亚胺己酰（MC）类型，与可裂解连接子相比，在血浆中更稳定，能抑制蛋白水解裂解。ADC 内化后需经溶酶体酶完全降解抗体才能释放有效载荷，药物释放依赖于抗体降解，如曲妥珠单抗 - 美坦新偶联物中的连接子。不可裂解连接子的 ADCs 通常无法产生旁观者效应，但其血浆稳定性高，有望降低脱靶毒性。 pH 敏感型：如含有酰肼基团的连接子，在溶酶体低 pH 值下释放药物，如 BR96 - Dox 中的酰肼连接子，但这类连接子在生理条件下可能不稳定。还原敏感型：含二硫键，利用癌细胞内高浓度的谷胱甘肽还原断裂释放药物，产生旁观者效应，如 Cantuzumab ravtansine 中的二硫键连接子。磷酸酯型：能显著提高连接子亲水性，水解机制虽未完全明确，但在体外研究中表现出优势，如抗 CD70 ADCs 中的磷酸酯连接子。肽基型：在全身循环中保持 ADC 稳定，通过特定细胞内蛋白酶（如组织蛋白酶 B）裂解释放药物，如 Val - Cit 和 Val - Ala 等连接子，在许多 ADCs 中使用，能保持血浆中 ADC 稳定性并利于在细胞内酶解。 β - 葡萄糖醛酸苷型：通过溶酶体中的 β - 葡萄糖醛酸酶裂解释放药物，引入自毁基团可提高稳定性和释放安全性，已用于多种 ADCs 中偶联不同细胞毒性药物。（三）有效载荷作用与要求有效载荷是通过连接子与单克隆抗体偶联的细胞毒性分子，在溶酶体裂解或环境变化（如氧化还原电位改变）后释放到细胞内，抑制肿瘤细胞增殖。理想的有效载荷应具有高细胞毒性、亲脂性、作用靶点在细胞内、分子小、无免疫原性、在水性缓冲溶液中有足够溶解度且在血浆中稳定等特点。分类及代表药物微管抑制剂：如美坦新类（如 DM1、DM4 等，其中 T - DM1 是首个获批用于实体瘤治疗的 ADC）和奥瑞他汀类（如 MMAE 等，抑制微管聚合，导致有丝分裂阻滞和细胞死亡）。 DNA 影响剂：包括拓扑异构酶 I 抑制剂（如 sacituzumab govitecan 和曲妥珠单抗 deruxtecan 等，可增加抗肿瘤免疫反应）、DNA 烷基化剂（如卡奇霉素、吡咯并苯并二氮杂卓二聚体、吲哚并苯并二氮杂卓、多卡霉素等，可导致 DNA 链断裂，诱导细胞凋亡）。抗体 - 药物偶联与效率（一）偶联方式与药物 - 抗体比（DAR）传统偶联方式及问题传统药物偶联在单克隆抗体骨架上进行，如通过烷基化或酰化赖氨酸侧链（如 GO 和曲妥珠单抗 - 美坦新），或还原二硫键释放半胱氨酸残基进行偶联（如 BV），但这些方法随机且导致 ADC 异质性，影响药代动力学、疗效和安全性。 DAR 的重要性与影响因素 DAR 是评估 ADC 效率的关键因素，定义为结合到单克隆抗体上的药物分子数量，其值通常为 2 - 8，理想 DAR 因有效载荷性质而异。 DAR 影响药物疗效和毒性，低载药量降低效力，高载药量影响毒性和药代动力学。例如，BV 的 DAR 值不同，其生物活性和药代动力学特性有差异，高 DAR 的 ADC 在体外活性高、血浆分布快，但可能因疏水性增加影响体内耐受性和清除率。（二）提高 ADC 效率的策略优化 DAR 特定的偶联技术可调节 DAR，位点特异性偶联（SSC）方法可合成更均质的 ADC，优化偶联位置，提高生物活性和分析表征，增强疗效。例如，通过 SSC 方法控制 DAR，可避免异质性问题，提高 ADC 的治疗效果。其他策略除优化 DAR 外，还可通过选择合适的连接子和有效载荷来提高 ADC 效率。例如，使用亲水性连接子调节疏水性，应用化学结构 - 治疗活性关系，选择高效细胞毒性 payload，提高血浆稳定性和 DAR 分布均匀性等。ADCs 的发展历程（一）第一代 ADCs 特点与问题以鼠源单克隆抗体与细胞毒性药物（如 DNA 破坏剂）偶联为特征，连接子为单价、不可裂解或酸不稳定型，稳定性差，治疗指数窄，缺乏精准肿瘤靶向性，且免疫原性高，易引发人体免疫反应。代表药物及现状 Gemtuzumab ozogamicin（GO）曾获批用于治疗 CD 阳性淋巴细胞白血病，但因多种问题（如与其他化疗药物相比无显著优势、严重肝毒性、连接子不稳定导致药物过早释放等）自愿撤市，后又重新获批。Inotuzumab ozogamicin 于 2017 年获批，是一种人源化单抗偶联药物，用于治疗表达 CD22 标志物的急性淋巴细胞白血病，不良反应较传统化疗少。（二）第二代 ADCs：位点定向偶联改进之处随着单克隆抗体技术发展，采用人源化抗体降低免疫原性，选择更有效的细胞毒性 payload，使用更稳定的连接子（如蛋白酶、肼、聚乙二醇和二硫键连接子等），提高了 ADC 的有效性和安全性。存在的问题仍存在治疗窗口窄、脱靶毒性、ADC 聚集、药物代谢快和清除迅速等问题。大多数第二代 ADC 的平均 DAR 值不同，DAR 大于 4 时，体内耐受性降低，血浆清除率增加，有效性下降。（三）第三代 ADCs 创新技术与特点采用多种创新技术，如开发双特异性单克隆抗体（IgG 样和非 IgG 样），具有两个不同结合位点，可通过旁观者效应释放毒素并激活自然杀伤细胞；使用抗原结合片段（Fabs）替代完整单克隆抗体，具有稳定性高、易内化、易纯化和免疫原性低等优点；发展位点特异性偶联技术，获得均质 ADC，优化 DAR，降低未结合抗体比例，提高 ADC 效率。近期获批药物及应用 2019 - 2022 年间，多种第三代 ADC 获批用于不同肿瘤治疗。如用于液体肿瘤的 polatuzumab vedotin、loncastuximab tesirine 等，用于固体肿瘤的 trastuzumab deruxtecan、enfortumab vedotin、sacituzumab govitecan 等。部分 ADC（如 sacituzumab govitecan 和 loncatuximab tesirine）在连接子技术中引入 PEG 链，增强体内溶解度和稳定性。安全性问题（一）脱靶效应产生原因 ADC 中的单克隆抗体可能与健康细胞表面表达的少量抗原相互作用，释放有效载荷导致正常细胞死亡；正常细胞表达的特定抗原也可导致脱靶细胞毒性；此外，ADC 在全身循环中，细胞毒性药物可能与其他脱靶抗原结合产生毒性；连接子不稳定导致有效载荷过早释放也会造成脱靶效应。（二）肿瘤异质性影响机制肿瘤细胞表面抗原表达水平不同，部分细胞抗原表达高，部分低或不表达，加上正常细胞的抗原表达，导致药物抵抗和疾病复发，影响 ADC 治疗效果。（三）其他安全性问题免疫系统相互作用免疫系统与 ADC 相互作用，可导致 ADC 消除，也可能激活针对正常细胞表达的靶抗原的免疫反应。有效载荷特性有效载荷治疗剂量和毒性剂量差异小，会增加脱靶效应风险。 ADC 代谢问题 ADC 的快速清除和低效代谢可导致全身毒性，包括对肝、肾等器官的毒性，神经系统毒性也是使用限制之一。药物相互作用 ADC 与其他药物（如细胞毒性药物或影响其代谢的药物）相互作用，可改变 ADC 的代谢，增加毒性风险。临床研究现状（一）已获批药物与临床应用自 2000 年以来，多种 ADC 已被 FDA 和 EMA 批准用于治疗血液系统和实体肿瘤，如 brentuximab vedotin、ado - trastuzumab emtansine 等，在相关肿瘤治疗中显示出一定疗效。（二）正在进行的临床试验大量 ADC 相关临床试验正在进行，截至 2024 年 2 月 19 日，ClinicalTrials.gov 数据库登记了 215 项，其中 36 项尚未招募患者。许多 ADC 在乳腺癌、白血病、肺癌等多种肿瘤治疗中展现出应用前景，如 Dato - DXd、trastuzumab deruxtecan 等在乳腺癌治疗中的研究，Gemtuzumab ozogamicin 在急性髓系白血病治疗中的研究等。前景与挑战（一）特异性抗原选择策略与意义选择在肿瘤细胞上高表达且在健康组织中低表达的特异性抗原，可提高 ADC 靶向性，降低毒性。同时，可将突变癌基因靶点纳入潜在抗原范围，考虑肿瘤抗原的异质性和动态性，选择合适抗原并利用旁观者效应，优化 ADC 作用。（二）ADC 结构优化技术与方法开发位点特异性标记策略，通过特定技术（如生物正交手柄引入、遗传密码扩展等）获得均质抗体偶联物，提高疗效和安全性。研究新的金属介导可裂解连接子，控制有效载荷释放，降低毒性。同时，需解决 ADC 偶联过程中的异质性问题，提高 DAR 的可控性和 ADC 的均质性。（三）耐药性和毒性优化策略耐药机制与应对措施肿瘤对 ADC 产生耐药性的机制包括肿瘤微环境改变、内化途径缺陷、抗原下调和主动外排等。为提高 ADC 有效性，可尝试规避或阻断这些耐药机制。毒性问题与解决方案 ADC 的毒性受多种因素影响，如抗原在非肿瘤组织中的生理作用、连接子稳定性、有效载荷特性和旁观者效应等。优化 ADC 结构和调整给药方案是降低毒性的潜在解决方案，同时在临床使用中需密切监测和管理不良反应。参考资料 Damelin, M., Zhong, W., Myers, J., et al. (2015) Evolving Strategies for Target Selection for Antibody-Drug Conjugates. Pharmaceutical Research, 32, 3494-3507. https://doi-org.libproxy1.nus.edu.sg/10.1007/s11095-015-1624-3 Metrangolo, V.; Engelholm, L.H. Antibody–Drug Conjugates: The Dynamic Evolution from Conventional to Next-Generation Constructs. Cancers 2024, 16, 447. https://doi-org.libproxy1.nus.edu.sg/ 10.3390/cancers16020447

抗体药物偶联物临床结果

2024-11-05

·PRNewswire

ADC Therapeutics Announces Investigator-Initiated Study Abstracts Accepted for Presentation at the 66th ASH Annual Meeting

Oral presentation of investigator-initiated Phase 2 study evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab in patients with r/r follicular lymphoma Poster presentation of first interim futility analysis of ongoing investigator-initiated Phase 2 clinical trial studying ZYNLONTA as treatment for r/r marginal zone lymphoma LAUSANNE, Switzerland, Nov. 5, 2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced independent, investigator-initiated study abstracts on ZYNLONTA® (loncastuximab tesirine-lpyl) have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting, which will be held in San Diego, California from December 7-10, 2024. "Data from the abstract on the Phase 2 study of ZYNLONTA combined with rituximab in patients with high-risk relapsed or refractory follicular lymphoma demonstrated a robust response among the 35 evaluable patients, with an overall response rate at week 12 of 97.1%," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "All complete metabolic responses were maintained, with 4 of the 10 partial metabolic responses improving at week 21 for a best complete metabolic response rate of 80%." "For relapsed or refractory marginal zone lymphoma, the abstract provides an update on ZYNLONTA as a single-agent treatment. As of the abstract submission date, the overall response rate was 85% with a complete response rate of 75% among the 20 evaluable patients," continued Dr. Zaki. "In both studies, safety was consistent with the known ZYNLONTA profile. We look forward to further updates at ASH." Details of the investigator-initiated study oral presentation: Title: Loncastuximab Tesirine with Rituximab Induces Robust and Durable Complete Metabolic Responses in High-Risk Relapsed/Refractory Follicular Lymphoma Abstract: 337 Session Title: 623. Mantle Cell, Follicular, Waldenstrom's and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Novel Treatment Strategies and New Data on Old Standards for Follicular Lymphoma Session Date and Time: Saturday, December 7, 2024; 4:00-5:30 p.m. PT Presentation Time: 4:00 p.m. PT Presenter: Juan Pablo Alderuccio, MD Location: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13 Details of the investigator-initiated study poster presentation: Title: Limited Duration Loncastuximab Tesirine Induces a High Rate of Complete Responses in Patients with Relapsed/Refractory Marginal Zone Lymphoma - Report of First Planned Interim Futility Analysis of a Multicenter Phase II Study Abstract: 3032 Session Title: 623. Mantle Cell, Follicular, Waldenstrom's and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Hall View Times: Sunday, December 8, 2024; 9:00 a.m. - 8:00 p.m. PT Presentation Date and Time: Sunday, December 8, 2024; 6:00-8:00 p.m. PT Location: San Diego Convention Center, Halls G-H The abstracts are available through the ASH online meeting program. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has operations in London and New Jersey. For more information, please visit the Company website at adctherapeutics.com and follow us on LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: whether the interim data presented in the abstract from the University of Miami's investigator-initiated trials studying ZYNLONTA® in FL and MZL are predictive of future outcomes and the timing and future results for the same ongoing trials, the potential regulatory and/or compendia strategy and the future opportunity for ZYNLONTA® in FL and MZL; the expected cash runway into mid-2026 the Company's ability to grow ZYNLONTA® revenue in the United States; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7, ADCT 601 and 602 as well as early research in certain solid tumors with different targets, linkers and payloads; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS: Investors Marcy Graham ADC Therapeutics [email protected] +1 650-667-6450 Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 SOURCE ADC Therapeutics SA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果ASH会议上市批准

2024-11-04

·PRNewswire

ADC Therapeutics to Present at November Investor Conferences

LAUSANNE, Switzerland, Nov. 4, 2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced participation in two investor conferences in November: Guggenheim Securities Healthcare Innovation Conference Date: November 11, 2024 Presentation Time: 11:00 a.m. ET Format: Fireside Chat Speaker: Ameet Mallik, Chief Executive Officer Jefferies London Healthcare Conference Date: November 19, 2024 Presentation Time: 11:00 a.m. GMT Format: Fireside Chat Speaker: Ameet Mallik, Chief Executive Officer Live webcasts of the presentations will be available via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ir.adctherapeutics.com. A replay of each webcast will be available for approximately 30 days following each event. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has operations in London and New Jersey. For more information, please visit the Company website at adctherapeutics.com and follow us on LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. CONTACTS: Investors Marcy Graham ADC Therapeutics [email protected] +1 650-667-6450 Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 SOURCE ADC Therapeutics SA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

抗体药物偶联物上市批准加速审批

100 项与泰朗妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11338	泰朗妥昔单抗	L01XC	DB16222

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
复发性弥漫性大B细胞淋巴瘤	挪威	Swedish Orphan Biovitrum AB	2022-12-20
复发性弥漫性大B细胞淋巴瘤	列支敦士登	Swedish Orphan Biovitrum AB	2022-12-20
复发性弥漫性大B细胞淋巴瘤	冰岛	Swedish Orphan Biovitrum AB	2022-12-20
复发性弥漫性大B细胞淋巴瘤	欧盟	Swedish Orphan Biovitrum AB	2022-12-20
难治性弥漫性大B细胞淋巴瘤活化B细胞型	挪威	Swedish Orphan Biovitrum AB	2022-12-20
难治性弥漫性大B细胞淋巴瘤活化B细胞型	冰岛	Swedish Orphan Biovitrum AB	2022-12-20
难治性弥漫性大B细胞淋巴瘤活化B细胞型	欧盟	Swedish Orphan Biovitrum AB	2022-12-20
难治性弥漫性大B细胞淋巴瘤活化B细胞型	列支敦士登	Swedish Orphan Biovitrum AB	2022-12-20
弥漫性大B细胞淋巴瘤	美国	ADC Therapeutics SA	2021-04-23
高级别B细胞淋巴瘤	美国	ADC Therapeutics SA	2021-04-23

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
大B细胞淋巴瘤	申请上市	中国	ADC Therapeutics SA	2023-06-08
大B细胞淋巴瘤	申请上市	中国	瓴路药业（上海）有限责任公司初创企业	2023-06-08
难治性弥漫性大 B 细胞淋巴瘤	临床3期	匈牙利	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	加拿大	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	瑞士	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	以色列	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	日本	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	中国	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	波多黎各	ADC Therapeutics SA	2020-09-16
难治性弥漫性大 B 细胞淋巴瘤	临床3期	英国	ADC Therapeutics SA	2020-09-16

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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


NCT05296070 (ASH2024) 人工标引	临床2期	复发性边缘区淋巴瘤 \| 边缘区淋巴瘤难治	22	Loncastuximab Tesirine	(膚壓構遞蓋網蓋繭觸鬱) = 淵衊選積鹽鏇膚襯衊襯觸蓋範築築壓遞衊襯齋 (衊鏇觸糧艱築蓋憲顧窪 ) 更多	积极	2024-12-08
NCT04998669 (ASH2024) 人工标引	临床2期	滤泡性淋巴瘤	39	Loncastuximab Tesirine + Rituximab	(蓋顧餘遞蓋遞窪夢選齋) = 鹽廠顧鏇膚選遞憲獵蓋範範繭積艱醖範齋鬱製 (網壓夢窪壓觸獵襯製顧 ) 更多	积极	2024-12-07
NCT04998669 (ASH2024) 人工标引	临床2期	滤泡性淋巴瘤	39	Loncastuximab Tesirine + Rituximab (Patients with POD24)	(蓋顧餘遞蓋遞窪夢選齋) = 顧窪鑰齋淵鹹構鏇壓願範範繭積艱醖範齋鬱製 (網壓夢窪壓觸獵襯製顧 ) 更多	积极	2024-12-07
SOHO2024	N/A	复发性弥漫性大B细胞淋巴瘤	-	Loncastuximab Tesirine	(壓鏇繭糧獵願願獵窪糧) = 構構選鑰築願觸鹹範願築製壓淵構鏇鑰襯鹽鑰 (衊衊鏇齋願選糧願簾壓 ) 更多	-	2024-09-04
SOHO2024	N/A	复发性弥漫性大B细胞淋巴瘤	-	Chimeric Antigen Receptor T-cell Therapy	(壓鏇繭糧獵願願獵窪糧) = 夢鬱網獵衊廠繭鑰製觸築製壓淵構鏇鑰襯鹽鑰 (衊衊鏇齋願選糧願簾壓 ) 更多	-	2024-09-04
NCT05296070 (Biospace) 人工标引	临床2期	边缘区淋巴瘤难治	50	Zynlonta	(夢鏇鑰築構廠觸顧鹽壓) = 鏇鏇願鑰醖遞觸鏇積獵襯範獵廠構鑰鹽蓋蓋製 (選衊遞鬱膚膚廠蓋衊膚 )	积极	2024-05-07
NCT03589469 (LOTIS-2, Pubmed) 人工标引	临床2期	难治性弥漫性大 B 细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤 CD19	145	Loncastuximab tesirine	(簾齋觸夢網築獵醖糧壓) = 鹹廠製鹽築糧鏇齋觸衊鏇夢願壓窪觸憲範鹹鹹 (獵鏇齋窪製範製齋夢窪, 50.0 ~ 81.0) 更多	积极	2024-04-01
NCT03684694 (LOTIS 3, CTgov)	临床1/2期	套细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	136	Ibrutinib+Loncastuximab Tesirine (Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib)	願憲築餘製簾觸獵壓醖(憲衊淵顧糧積醖鑰鏇繭) = 鹽鑰鏇餘夢範鬱獵齋膚遞構壓窪遞衊繭夢鏇繭 (鏇衊遞襯繭衊鏇選繭網, 憲蓋繭顧糧餘範積壓製 ~ 襯衊製鏇築廠膚餘觸範) 更多	-	2024-02-06
NCT03684694 (LOTIS 3, CTgov)	临床1/2期	套细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	136	Ibrutinib+Loncastuximab Tesirine (Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib)	願憲築餘製簾觸獵壓醖(憲衊淵顧糧積醖鑰鏇繭) = 蓋艱襯鑰醖選蓋繭獵醖遞構壓窪遞衊繭夢鏇繭 (鏇衊遞襯繭衊鏇選繭網, 鑰淵願糧範築鹹選鹹網 ~ 築繭網淵膚憲糧願鹹鹽) 更多	-	2024-02-06
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	弥漫性大B细胞淋巴瘤三线	81	Loncastuximab Tesirine (who received CAR-T at 2L/lonca at 3L)	(膚製築範網顧繭獵繭顧) = 蓋憲鑰鹽鹹製齋範壓獵衊構網願艱鬱醖窪廠鏇 (衊鹽鹹網製膚遞齋膚鏇 ) 更多	积极	2024-02-01
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	弥漫性大B细胞淋巴瘤三线	81	Loncastuximab Tesirine + Loncastuximab Tesirine3L/lonca at 4L	(膚製築範網顧繭獵繭顧) = 遞壓鬱獵憲鏇選憲齋窪衊構網願艱鬱醖窪廠鏇 (衊鹽鹹網製膚遞齋膚鏇 ) 更多	积极	2024-02-01
GlobeNewswire 人工标引	N/A	滤泡性淋巴瘤	-	ZYNLONTA + rituximab	(簾鏇築願鑰選願鏇鹹憲) = 糧壓壓壓淵鏇選蓋衊鏇夢壓夢鏇糧窪壓衊夢醖 (簾鹽願願齋製鏇淵廠襯 ) 更多	积极	2024-01-04
LOTIS-7 (GlobeNewswire) 人工标引	临床1期	滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤 \| 边缘区B细胞淋巴瘤	-	mosunetuzumab or glofitamab+ZYNLONTA	(齋襯壓壓窪醖遞醖鏇衊) = The dose-limiting toxicity (DLT) period has been cleared for the first dosing level of ZYNLONTA 90 µg/kg in both arms, 壓構遞築淵觸遞觸鏇製 (鏇鏇顧憲艱鹹蓋壓製淵 )	积极	2024-01-04
ChiCTR2300072058 (ASH2023) 人工标引	临床2期	弥漫性大B细胞淋巴瘤	64	Loncastuximab Tesirine	(窪糧鬱鏇衊簾構繭積衊) = 鹹願繭網鹹築憲鬱積鏇窪蓋蓋壓積製壓餘壓顧 (窪醖繭製壓鬱鬱襯醖襯, 38.7 ~ 64.2) 更多	积极	2023-12-11