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Article(id=1241022577368428686, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241022576185634950, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.09.03, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1657814400000, receivedDateStr=2022-07-15, revisedDate=null, revisedDateStr=null, acceptedDate=1721750400000, acceptedDateStr=2024-07-24, onlineDate=1773812439529, onlineDateStr=2026-03-18, pubDate=1727193600000, pubDateStr=2024-09-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773812439529, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773812439529, creator=13701087609, updateTime=1773812439529, updator=13701087609, issue=Issue{id=1241022576185634950, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='9', pageStart='641', pageEnd='720', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773812439247, creator=13701087609, updateTime=1773813972032, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241029005206417725, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241022576185634950, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241029005206417726, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241022576185634950, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=651, endPage=656, ext={EN=ArticleExt(id=1241022577611698324, articleId=1241022577368428686, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Research progress of antibody-drug conjugate therapy for malignant lymphoma, columnId=1207314219599499390, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

Malignant lymphoma (ML) is a heterogeneous malignant tumor in the hematological system, the existing treatment methods can not meet the clinical needs, and the rapid rise of new treatment schemes has improved the survival benefits of patients with recurrent or refractory ML. Antibody-drug conjugate (ADC), as a new type of highly effective anti-tumor drug composed of monoclonal antibodies specifically targeting tumor cell surface antigens, coupled with small molecular cytotoxic loads through chemical connectors, has attracted much attention in the application prospect of malignant lymphoma. Several ADCs have been approved for the treatment of ML, including brentuximab vedotin, inotuzumab ozogamicin, moxetumomab pasudotox, polatuzumab vedotinands, loncastuximab tesirine, etc. These drugs can exert anti-tumor effects by targeting CD30, CD22, CD79b, CD19, etc. on the surface of tumor cells with good efficacy and safety.

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恶性淋巴瘤是血液系统中的一种异质性恶性肿瘤，现有治疗手段未能满足临床需求，新型治疗方案的快速兴起提高了复发或难治性恶性淋巴瘤患者的生存获益。抗体偶联药物作为一种由特异性靶向肿瘤细胞表面抗原的单克隆抗体通过化学连接子偶联小分子细胞毒性载荷而组成的新型高效抗肿瘤药物，在恶性淋巴瘤中的应用前景备受瞩目。目前已有多款治疗恶性淋巴瘤的抗体偶联药物获批，包括维布妥昔单抗、奥加伊妥珠单抗、moxetumomab pasudotox、维泊妥珠单抗和loncastuximab tesirine等。这些药物可通过靶向肿瘤细胞表面的CD30、CD22、CD79b、CD19等发挥抗肿瘤作用，疗效和安全性均较好。

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孔凡铭
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王娜，女，博士在读，主要从事中西医结合治疗肿瘤的临床及基础研究，E-mail：

孔凡铭，男，主任医师，博士生导师，博士，主要从事中西医结合治疗肿瘤的临床及基础研究，E-mail：

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王娜 1, 2, 3 , 孔凡铭 1, 2, 3
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中国新药与临床杂志 | 综述 2024, 43(9): 651-656
抗体偶联药物治疗恶性淋巴瘤的研究进展
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王娜1, 2, 3 , 孔凡铭1, 2, 3
作者信息
  • 1.天津中医药大学第一附属医院 肿瘤科，天津　300381
  • 2.国家中医针灸临床医学研究中心，天津　300381
  • 3.天津市中医肿瘤研究所，天津　300381

    • 王娜，女，博士在读，主要从事中西医结合治疗肿瘤的临床及基础研究，E-mail：

    孔凡铭，男，主任医师，博士生导师，博士，主要从事中西医结合治疗肿瘤的临床及基础研究，E-mail：

通讯作者:

孔凡铭
Research progress of antibody-drug conjugate therapy for malignant lymphoma
Na WANG1, 2, 3 , Fan-ming KONG1, 2, 3
Affiliations
  • 1.Department of Oncology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, TIANJIN 300381, China
  • 2.National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, TIANJIN 300381, China
  • 3.Tianjin Cancer Institute of Traditional Chinese Medicine, TIANJIN 300381, China
出版时间: 2024-09-25 doi: 10.14109/j.cnki.xyylc.2024.09.03
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摘要
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恶性淋巴瘤是血液系统中的一种异质性恶性肿瘤，现有治疗手段未能满足临床需求，新型治疗方案的快速兴起提高了复发或难治性恶性淋巴瘤患者的生存获益。抗体偶联药物作为一种由特异性靶向肿瘤细胞表面抗原的单克隆抗体通过化学连接子偶联小分子细胞毒性载荷而组成的新型高效抗肿瘤药物，在恶性淋巴瘤中的应用前景备受瞩目。目前已有多款治疗恶性淋巴瘤的抗体偶联药物获批，包括维布妥昔单抗、奥加伊妥珠单抗、moxetumomab pasudotox、维泊妥珠单抗和loncastuximab tesirine等。这些药物可通过靶向肿瘤细胞表面的CD30、CD22、CD79b、CD19等发挥抗肿瘤作用，疗效和安全性均较好。

抗体偶联药物  /  恶性淋巴瘤  /  抗肿瘤药

Malignant lymphoma (ML) is a heterogeneous malignant tumor in the hematological system, the existing treatment methods can not meet the clinical needs, and the rapid rise of new treatment schemes has improved the survival benefits of patients with recurrent or refractory ML. Antibody-drug conjugate (ADC), as a new type of highly effective anti-tumor drug composed of monoclonal antibodies specifically targeting tumor cell surface antigens, coupled with small molecular cytotoxic loads through chemical connectors, has attracted much attention in the application prospect of malignant lymphoma. Several ADCs have been approved for the treatment of ML, including brentuximab vedotin, inotuzumab ozogamicin, moxetumomab pasudotox, polatuzumab vedotinands, loncastuximab tesirine, etc. These drugs can exert anti-tumor effects by targeting CD30, CD22, CD79b, CD19, etc. on the surface of tumor cells with good efficacy and safety.

antibody-drug conjugate  /  malignant lymphomas  /  antineoplastic agents
王娜, 孔凡铭. 抗体偶联药物治疗恶性淋巴瘤的研究进展. 中国新药与临床杂志, 2024 , 43 (9) : 651 -656 . DOI: 10.14109/j.cnki.xyylc.2024.09.03
Na WANG, Fan-ming KONG. Research progress of antibody-drug conjugate therapy for malignant lymphoma[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (9) : 651 -656 . DOI: 10.14109/j.cnki.xyylc.2024.09.03
正文
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恶性淋巴瘤（malignant lymphoma，ML）是血液系统中最常见的恶性肿瘤，其病理类型或亚型繁杂且具有高度异质性。与实体瘤不同，ML的病理类型往往比临床分期更能提示临床预后[1,2]。随着精准治疗和个体化治疗理念的不断深入，除外科手术和放化疗等传统的治疗手段外，靶向治疗、免疫治疗和嵌合抗原受体T细胞（chimeric antigen receptor T cells，CAR-T）等一系列新兴抗肿瘤方案在ML的临床治疗实践中发挥了日益重要的作用[3-5]。尽管以上治疗方法发挥了一定的抗肿瘤效应，但仍有约10%的ML患者复发或对标准治疗无效。这些患者通常需接受挽救性化疗，若对化疗敏感，则可采用自体外周血造血干细胞支持下的大剂量化疗方案。然而，即使如此，仍有约50%的患者会再次复发，后续的治疗方案仅限于姑息性治疗或参与临床试验[6]。
抗体偶联药物（antibody-drug conjugate，ADC）作为一种新型高效的抗肿瘤药物，在ML等血液系统肿瘤中的临床应用日益受到重视。ADC主要由3个部分组成，分别是特异性靶向肿瘤细胞表面抗原的单抗隆抗体，对肿瘤细胞发挥高效杀伤作用的小分子细胞毒性载荷，以及稳定性好、裂解效率高的化学连接子[7]。细胞毒性载荷又分为DNA损伤剂和微管蛋白抑制剂，其中，DNA损伤剂通过抑制肿瘤细胞DNA的合成、诱导DNA双链的断裂和损伤等作用发挥抗肿瘤活性；微管蛋白抑制剂则通过抑制微管蛋白的聚集和纺锤体的形成，或改变细胞骨架结构而诱导肿瘤细胞的生长抑制和细胞凋亡[8]。近年来，ADC在ML的临床试验中取得了令人瞩目的成果。本文重点对现阶段获批治疗ML的ADC的研究进展作一综述，旨在探讨ADC在ML患者中的临床疗效、用药安全性及其应用前景。
靶向CD30的ADC
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CD30是一种Ⅰ型跨膜受体糖蛋白，属于肿瘤坏死因子超家族（tumor necrosis factor superfamily，TNFRSF）中的一员。CD30主要表达于霍奇金淋巴瘤（Hodgkin lymphoma，HL）和间变大细胞淋巴瘤，部分表达于活化的T细胞和B细胞中，且通常不表达于健康组织，这种差异化表达使CD30成为一个理想的治疗靶点[9]。CD30具有依赖于环境和靶细胞的多种功能，参与了细胞的增殖和凋亡[10]。
维布妥昔单抗（brentuximab vedotin，BV）是一种由靶向CD30的免疫球蛋白（immunoglobulin，Ig）G1单抗本妥昔单抗组成的ADC，通过蛋白酶可裂解的二肽连接子，偶联微管蛋白抑制剂一甲基澳瑞他汀E（monomethyl auristatin E，MMAE），其药物-抗体比（drug-to-antibody ratio，DAR）为4[11]。
一项关键性的Ⅱ期临床试验（NCT00848926）纳入了102例既往接受自体干细胞移植（autologous stem cell transplantation，ASCT）治疗后复发或难治性（relapsed/refractory，R/R）HL患者，用于评估BV在CD30阳性HL患者中的临床疗效和用药安全性。研究结果表明，患者的客观缓解率（objective response rate，ORR）为75%（95%CI为64.9%~82.6%），其中34%的受试者达到完全缓解（complete remission，CR）（95%CI为25.32%~44.4%）；患者的中位无进展生存期（progression free survival，PFS）为5.6个月（95%CI为5.0~9.0），其中CR患者的中位缓解持续时间（duration of response，DOR）为20.5个月。最常见的治疗相关不良反应（treatment-related adverse events，TRAEs）是周围感觉神经病变（42%）、恶心（35%）和疲劳（34%）等[12]。基于此项试验结果，BV于2011年8月被美国食品和药物管理局（FDA）批准用于治疗ASCT失败，或既往接受2种及以上多药化疗方案失败且不适合进行ASCT的R/R HL患者。随后的一项5年随访研究数据表明，上述患者的生存率和无进展生存率分别为41%和22%，其中CR患者的总生存率和无进展生存率分别为64%和52%。使用BV单药治疗R/R HL实现了疾病的长期控制，并有可能实现治愈[13]。2020年5月，BV正式获得我国国家药品监督管理局（National Medical Products Administration，NMPA）批准上市，适应证为R/R系统性间变性大细胞淋巴瘤（systemic anaplastic large cell lymphoma，sALCL）和R/R经典型霍奇金淋巴瘤（classical Hodgkin lymphoma，cHL）。
此外，NCT01060904和ECHELON-1（NCT01712490）等临床试验表明，BV联合化疗在HL一线治疗中日趋重要，其能在减少传统化疗方案严重毒副作用的同时提高总体生存疗效[14-16]。NCT01393717和NCT02280993等临床试验表明，BV联合化疗作为一线治疗后R/R HL患者行ASCT前的挽救治疗方案，可获得较高的CR率并有助于患者最终完成ASCT[17,18]。NCT01657331和NCT01990534等临床研究表明，BV作为多线治疗后的挽救治疗方案，可显著延长R/R HL患者的生存期[19,20]。AETHERA（NCT01100502）研究证明，R/R HL患者完成ASCT后早期行BV维持治疗可使患者达到长期疾病控制，BV组患者的PFS显著长于安慰剂组［42.9个月vs. 24.1个月，风险比（hazard ratio，HR）= 0.57，95%CI为0.40~0.81，P=0.001 3］[21]。NCT00947856研究还表明，对于经BV维持治疗后仍然进展的HL患者，再次行BV治疗仍可从中获益[22]。综上所述，BV用于HL患者的一线治疗或挽救治疗均表现出良好的临床获益和安全性。
靶向CD22的ADC
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CD22是唾液酸结合免疫球蛋白样凝集素家族中的一员，部分表达于成熟B细胞和大多数恶性B淋巴瘤的表面，在B细胞的增殖、分化和抑制B细胞受体（B-cell receptor，BCR）钙信号传导方面发挥重要作用[23]。
1　奥加伊妥珠单抗（inotuzumab ozogamicin，InO）
InO是一种由靶向CD22的人源化IgG4单抗（G544）通过可酸解的连接子偶联卡奇霉素衍生物组成的ADC[24]。细胞毒性载荷卡奇霉素衍生物通过与肿瘤细胞的DNA小沟槽结合，可使DNA双链断裂，从而引起细胞周期停滞和细胞凋亡[25]。
INO-VATE研究（NCT01564784）是一项开放标签、国际多中心的Ⅲ期临床试验，该研究纳入了326例R/R前体B细胞急性淋巴细胞白血病（precursor B-cell acuteacute lymphoblastic leukemia，B-ALL）患者，治疗组予以InO单药治疗，对照组予以标准强化化疗。研究结果表明，治疗组患者的CR率显著高于对照组（80.7% vs. 29.4%，P<0.001），且治疗组的中位DOR显著长于对照组（4.6个月vs. 3.1个月，P<0.001）；治疗组和对照组的PFS分别为5.0个月（95%CI为3.7~5.6）和1.8个月（95%CI为1.5~2.2），总生存期（overall survival，OS）分别为7.7个月（95%CI为6.0~9.2）和6.7个月（95%CI为4.9~8.3）。治疗组和对照组最常见的3级及其以上TRAEs是血小板减少（37% vs. 59%）和发热性中性粒细胞减少（24% vs. 49%）；与对照组相比，治疗组患者肝脏相关毒性的发生率更高（转氨酶水平升高20% vs. 10%，高胆红素血症15% vs. 10%，肝窦阻塞综合征11% vs. 1%），尤其是接受造血干细胞移植的患者发生肝窦阻塞综合征的风险更高（21% vs.5%）[26]。基于此项研究结果，FDA和NMPA先后于2017年8月和2021年12月批准InO用于治疗R/R B-ALL的成年患者[27,28]。除单药治疗外，InO与化疗方案联合治疗R/R B-ALL的临床试验也在开展中。一项Ⅱ期临床试验（NCT01371630）给予59例R/R B-ALL患者InO联合低强度的化疗方案（mini-HCVD:环磷酰胺，地塞米松剂量减少50%，不使用蒽环类药物，甲氨蝶呤剂量减少75%，阿糖胞苷0.5 g·m-2×4），结果表明，ORR为78%，CR为59%，微小残留病变（minimal residual disease，MRD）阴性率为82%，26例（44%）患者接受了ASCT；3级及其以上TRAEs包括血小板减少（81%）、感染（73%）和高胆红素血症（14%）等；患者无复发存活期（relapse-free survival，RFS）和OS分别为8个月和11个月，1年无复发存活率和总生存率分别为40%和46%。可见，InO在单药治疗或联合治疗R/R B-ALL患者中均表现出良好的临床疗效和用药安全性；44%的患者顺利进行了随后的ASCT，表明InO联合miniHCVD是过渡性治疗的一种选择方案[29]。
2　moxetumomab pasudotox（MP）
MP是一种抗CD22的免疫重组ADC，由靶向CD22的单抗Fv片段和假单胞菌外毒素的38 000片段（PE38）通过二肽连接子偶联组成[30]。PE38可通过诱导延伸因子-2（elongation factor-2，EF-2）的邻苯二甲酰胺残基被腺苷二磷酸核糖基化，使抗凋亡蛋白Mcl-1水平迅速下降，从而造成细胞凋亡[31]。
一项关键性的单臂试验（NCT01829711）纳入了80例R/R毛细胞白血病（hairy cell leukemia，HCL）患者，予其40 µg·kg-1 MP治疗，主要研究终点是持久CR率（定义为血液学缓解持续时间>180 d或≥360 d的患者比例；血液学缓解要求中性粒细胞计数≥1.5×103·µL-1，血小板计数≥100×103·µL-1，血红蛋白计数≥11.0 g·dL-1，无输血或输注生长因子≥4周）。研究结果表明，患者达到CR持续时间>180 d的持久CR率为36%，持续时间≥360 d的CR率为33%，总CR率为41%；27例（82%）CR患者的MRD为阴性；最常见的TRAEs是恶心（28%）、水肿（26%）、头痛（21%）和发热（20%），严重不良反应包括溶血性尿毒症综合征和毛细血管渗漏综合征[32]。基于此项研究结果，FDA于2018年9月批准MP用于治疗既往接受过2种及以上系统疗法（包括嘌呤核苷类似物）治疗失败的R/R HCL成年患者[33]。
靶向CD79b的ADC
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CD79b是一种B细胞表面抗原，对BCR的表达和功能具有重要意义[34]，其可在90%以上的非霍奇金淋巴瘤（non-Hodgkin lymphoma，NHL）中表达。CD79b与抗体结合后会被迅速内吞并递送至溶酶体内，因此CD79b是递送细胞毒性载荷的重要靶点[35]。
维泊妥珠单抗（polatuzumab vedotin，Pola）是一种由靶向CD79b的IgG1单抗（SN8）通过蛋白酶可裂解的连接子偶联MMAE而组成的ADC，其DAR平均为3~4[36]。一项开放标签、多中心的Ⅰ期临床试验（NCT01290549）结果表明，2.4 mg·kg-1的Pola单药治疗对NHL有效而对慢性淋巴细胞白血病疗效较差[37]。ROMULUS研究是一项Ⅱ期临床试验（NCT01691898），该研究纳入了39例接受利妥昔单抗联合Pola治疗的弥漫性大B细胞淋巴瘤（diffuse large B-cell lymphoma，DLBCL）患者，其ORR为54%，8例（21%）患者获得CR；在接受利妥昔单抗联合Pola治疗的20例滤泡性淋巴瘤（follicular lymphoma，FL）患者中，其ORR为70%，9例（45%）患者获得CR。在DLBCL队列中，最常见的TRAEs是中性粒细胞减少（23%）、贫血（8%）和腹泻（8%）；在FL队列中，最常见的TRAEs是中性粒细胞减少（15%）和腹泻（10%）[38]。一项Ⅰb/Ⅱ期临床试验（NCT02257567）评估了Pola+苯达莫司汀+奥妥珠单抗（Pola-BG）以及Pola+利妥昔单抗联合或不联合苯达莫司汀（Pola-BR或BR）的疗效和安全性。结果，Pola-BG队列的CR为29.6%，OS为10.8个月；与BR方案相比，Pola-BR方案可显著提高DLBCL患者的CR（40% vs. 17%），延长PFS（9.5个月vs. 3.7个月）和OS（12.4个月vs. 4.7个月），并可降低58%的死亡风险[39]。一项开放标签、非随机化的Ⅰb/Ⅱ期临床试验（NCT01992653）评估了Pola+环磷酰胺+阿霉素+泼尼松+利妥昔单抗或奥妥珠单抗（Pola-R-CHP或Pola-G-CHP）联合治疗方案在既往未接受过治疗的DLBCL患者中的安全性和有效性。结果，其ORR为89%，CR为77%；最常见的3级及以上TRAEs是中性粒细胞减少（30%）和发热性中性粒细胞减少（18%）[40]。POLARIX研究（NCT03274492）是一项双盲、安慰剂对照的Ⅲ期临床试验，该研究纳入了879例既往未接受过治疗的DLBCL患者，并将其随机分为治疗组和对照组，治疗组患者（n=440）接受Pola+利妥昔单抗+环磷酰胺+阿霉素+强的松（Pola-R-CHP）治疗，对照组患者（n=439）接受利妥昔单抗+环磷酰胺+阿霉素+长春新碱+强的松（R-CHOP）治疗。结果，患者中位随访时间为28.2个月，Pola-R-CHP组的进展、复发或死亡的风险显著低于R-CHOP组（HR=0.73，95%CI为0.57~0.95，P=0.02），Pola-R-CHP组的2年无进展存活率显著高于R-CHOP组（76.7% vs. 70.2%，P<0.05），但两组的2年总生存率无显著差异（88.7% vs. 88.6%，P>0.05），且安全性也相似[41]。
综上，Pola在DLBCL患者的治疗中显示出优越的疗效和可控的安全性，作为首款靶向CD79b的ADC，2019年6月FDA批准Pola-BR联合方案可用于治疗不适合进行ASCT的R/R DLBCL成年患者。此外，欧盟于2022年5月批准Pola-R-CHP联合方案可用于一线治疗DLBCL成年患者。
靶向CD19的ADC
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CD19是特异性表达于B淋巴细胞及滤泡树突状细胞的表面蛋白，属于免疫球蛋白超家族成员。CD19可通过BCR依赖和非依赖方式调节B细胞的活化、增殖和信号传导[42]。
loncastuximab tesirine是一种由靶向CD19的人源化单抗通过蛋白酶可切割的连接子偶联吡咯苯并二氮杂䓬（pyrrolobenzodiazepine，PBD）二聚体细胞毒素SG3199而组成的ADC[43]。一项剂量递增、剂量扩展的Ⅰ期临床试验（NCT02669017）结果表明，loncastuximab tesirine治疗R/R DLBCL的Ⅱ期推荐剂量为每3周1次，每次150 µg·kg-1，连续2个周期；之后每3周1次，每次75 µg·kg-1[44,45]。LOTIS-2研究（NCT03589469）是一项单臂、多中心的Ⅱ期临床试验，145例接受loncastuximab tesirine治疗的R/R DLBCL患者中各有35例患者达到CR和部分缓解（partical response，PR），ORR为48.3%（95%CI为39.9%~56.7%）；最常见的3级及以上TRAEs是中性粒细胞减少（26%）、血小板减少（18%）和γ-谷氨酰基转移酶升高（17%），未发生治疗相关性死亡事件[46]。基于该项临床试验的积极效果，FDA于2021年4月批准loncastuximab tesirine用于治疗既往接受过2线及以上治疗的R/R大B细胞淋巴瘤成年患者，其中包括DLBCL、由低级别淋巴瘤引起的DLBCL以及高级别B细胞淋巴瘤。
loncastuximab tesirine是FDA批准的首款靶向CD19的ADC[47]。最近的研究表明，靶向CD19的其他ADC如coltuximab ravtansine（SAR3419）、denintuzumab mafodotin（SGN-CD19A）等也在前期临床试验中表现出一定的抗肿瘤活性和用药安全性，但其投入临床实践仍需进一步的数据支持[48,49]。
结语
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ADC能特异性靶向肿瘤细胞表面抗原并直接提供小分子细胞毒性药物，实现了小分子化疗和单抗药物靶向治疗以减毒增效为目的的强强联合，为实现ML的精准治疗提供了一种崭新的途径。ML会表达多种特异的细胞表面标记物，除上文所述的多个靶点外，其他一系列靶向ML抗原靶点（例如CD25、CD37、CD70等）的ADC也正在临床前研究或临床试验中。然而，ADC仍存在诸如半衰期短、DAR不均质、偶联位点杂乱等不利的药动学特征和非靶向效应，且ADC中的连接子若在抗体识别并结合靶抗原前裂解，会导致全身毒性，进而使靶抗原表达下调或突变，降低ADC疗效。生产工艺的改进、ADC结构的修改以及其他抗ML药物的联合应用可能有助于减轻毒副反应，克服耐药。目前ADC的研发重点在于不断优化单抗和靶标的选择以提高靶向杀伤的特异性，探索更有效的细胞毒性载荷以增强抗肿瘤活性和避免器官特异性毒性，继续改善接头和连接技术以获得均一的DAR，提高药物的稳定性并将脱靶毒性降至最低。此外，随着ADC联合治疗方案的不断优化，进一步准确筛选优势患者人群、选择合适的药物剂量和周期、完善用药方案和不良反应的长期管理方案，均有助于改善ML患者的临床疗效和预后。
基金
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  • 天津市卫生计生行业高层次人才选拔培养工程项目
  • 吴阶平医学基金会项目(320.6750.2023-10-5)
文献
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2024年第43卷第9期
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doi: 10.14109/j.cnki.xyylc.2024.09.03
  • 接收时间：2022-07-15
  • 首发时间：2026-03-18
  • 出版时间：2024-09-25
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  • 收稿日期：2022-07-15
  • 录用日期：2024-07-24
基金
天津市卫生计生行业高层次人才选拔培养工程项目
吴阶平医学基金会项目(320.6750.2023-10-5)
作者信息
    1.天津中医药大学第一附属医院 肿瘤科，天津　300381
    2.国家中医针灸临床医学研究中心，天津　300381
    3.天津市中医肿瘤研究所，天津　300381

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孔凡铭
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