Pharmacokinetic/pharmacodynamic relationship of therapeutic monoclonal antibodies used in oncology: Part 2, immune checkpoint inhibitor antibodies

被引:63
作者
Desnoyer, Aude [1 ,2 ]
Broutin, Sophie [3 ]
Delahousse, Julia [3 ]
Maritaz, Christophe [1 ]
Blondel, Louis [1 ]
Mir, Olivier [4 ]
Chaput, Nathalie [1 ,2 ]
Paci, Angelo [1 ,3 ]
机构
[1] Univ Paris Saclay, Fac Pharm, F-92290 Chatenay Malabry, France
[2] Lab Immunomonitoring Oncol, Gustave Roussy Canc Campus, F-94805 Villejuif, France
[3] Dept Pharmacol, Gustave Roussy Canc Campus, F-94805 Villejuif, France
[4] Dept Ambulatory Care, Gustave Roussy Canc Campus, F-94805 Villejuif, France
关键词
Checkpoint inhibitors; Pharmacokinetics; Pharmacodynamic properties; Therapeutic drug monitoring; Cancer; CLINICAL ACTIVITY; PHASE-I; NIVOLUMAB EXPOSURE; DOSE-ESCALATION; SOLID TUMOR; IPILIMUMAB; PHARMACOKINETICS; PEMBROLIZUMAB; SAFETY; CANCER;
D O I
10.1016/j.ejca.2020.01.003
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Immune checkpoint inhibitors are monoclonal antibodies (mAbs) directed against negative immunologic regulators that are used to restore the immune response against cancer. Approved drugs include anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), anti-programmed cell death 1 (PD-1) and anti-programmed cell death-ligand 1 (PD-L1) antibodies exhibiting pharmacokinetic (PK) characteristics typical of mAbs. Most factors such as age, sex, ethnicity, tumour burden, performance status and immunogenicity, but not body weight, do not seem to affect drug clearance clinically. However, an exposure-response relation has been described for both the efficacy and toxicity of anti-CTLA-4 and anti-PD-1 agents. The change in clearance over time is associated with overall response at least for nivolumab and pembrolizumab. Few PK/pharmacodynamic (PD) data are available for anti-PD-L1 mAbs, but time-varying clearance has been described for these drugs, and the high immunogenicity rate observed with atezolizumab may affect PK parameters and should be further studied. These data suggest the need for additional PK/PD studies. In this review, we summarise studies of the PKs of immune checkpoint inhibitors, exploring possible interactions with PD considerations. (C) 2020 Elsevier Ltd. All rights reserved.
引用
收藏
页码:119 / 128
页数:10
相关论文
共 59 条
[11]   Phase I Study of Single-Agent Anti-Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates [J].
Brahmer, Julie R. ;
Drake, Charles G. ;
Wollner, Ira ;
Powderly, John D. ;
Picus, Joel ;
Sharfman, William H. ;
Stankevich, Elizabeth ;
Pons, Alice ;
Salay, Theresa M. ;
McMiller, Tracee L. ;
Gilson, Marta M. ;
Wang, Changyu ;
Selby, Mark ;
Taube, Janis M. ;
Anders, Robert ;
Chen, Lieping ;
Korman, Alan J. ;
Pardoll, Drew M. ;
Lowy, Israel ;
Topalian, Suzanne L. .
JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (19) :3167-3175
[12]  
Chatterjee MS, 2017, CPT-PHARMACOMET SYST, V6, P29, DOI 10.1002/psp4.12140
[13]   Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor [J].
Deng, Rong ;
Bumbaca, Daniela ;
Pastuskovas, Cinthia V. ;
Boswell, C. Andrew ;
West, David ;
Cowan, Kyra J. ;
Chiu, Henry ;
McBride, Jacqueline ;
Johnson, Clarissa ;
Xin, Yan ;
Koeppen, Hartmut ;
Leabman, Maya ;
Iyer, Suhasini .
MABS, 2016, 8 (03) :593-603
[14]  
Elassaiss-Schaap J, 2017, CPT-PHARMACOMET SYST, V6, P21, DOI 10.1002/psp4.12132
[15]   Nivolumab Exposure-Response Analyses of Efficacy and Safety in Previously Treated Squamous or Nonsquamous Non-Small Cell Lung Cancer [J].
Feng, Yan ;
Wang, Xiaoning ;
Bajaj, Gaurav ;
Agrawal, Shruti ;
Bello, Akintunde ;
Lestini, Brian ;
Finckenstein, Friedrich Graf ;
Park, Jong-Soon ;
Roy, Amit .
CLINICAL CANCER RESEARCH, 2017, 23 (18) :5394-5405
[16]   Model-based clinical pharmacology profiling of ipilimumab in patients with advanced melanoma [J].
Feng, Yan ;
Masson, Eric ;
Dai, David ;
Parker, Susan M. ;
Berman, David ;
Roy, Amit .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2014, 78 (01) :106-117
[17]   Exposure-Response Relationships of the Efficacy and Safety of Ipilimumab in Patients with Advanced Melanoma [J].
Feng, Yan ;
Roy, Amit ;
Masson, Eric ;
Chen, Tai-Tsang ;
Humphrey, Rachel ;
Weber, Jeffrey S. .
CLINICAL CANCER RESEARCH, 2013, 19 (14) :3977-3986
[18]   A retrospective examination of the US Food and Drug Administration's clinical pharmacology reviews of oncology biologics for potential use of therapeutic drug monitoring [J].
Fleisher, Brett ;
Ait-Oudhia, Sihem .
ONCOTARGETS AND THERAPY, 2018, 11 :113-121
[19]   Evaluation of dosing strategy for pembrolizumab for oncology indications [J].
Freshwater, Tomoko ;
Kondic, Anna ;
Ahamadi, Malidi ;
Li, Claire H. ;
de Greef, Rik ;
de Alwis, Dinesh ;
Stone, Julie A. .
JOURNAL FOR IMMUNOTHERAPY OF CANCER, 2017, 5
[20]   Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma [J].
Geoerger, Birgit ;
Bergeron, Christophe ;
Gore, Lia ;
Sender, Leonard ;
Dunkel, Ira J. ;
Herzog, Cynthia ;
Brochez, Lieve ;
Cruz, Ofelia ;
Nysom, Karsten ;
Berghorn, Elmer ;
Simsek, Burcin ;
Shen, Jun ;
Pappo, Alberto .
EUROPEAN JOURNAL OF CANCER, 2017, 86 :358-363