Population pharmacokinetics and exposure–response relationship of amatuximab, an anti-mesothelin monoclonal antibody, in patients with malignant pleural mesothelioma and its application in dose selection
Purpose To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural mesothelioma (MPM) receiving amatuximab with pemetrexed and cisplatin. Methods A nonlinear mixed effects PK model was built using data fr...
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Published in | Cancer chemotherapy and pharmacology Vol. 77; no. 4; pp. 733 - 743 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.04.2016
Springer Nature B.V |
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Abstract | Purpose
To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural mesothelioma (MPM) receiving amatuximab with pemetrexed and cisplatin.
Methods
A nonlinear mixed effects PK model was built using data from all of the amatuximab studies conducted to date. Patients received amatuximab alone or in combination with chemotherapy. The influence of demographic, laboratory and disease characteristics on PK parameters was assessed. Exposure–response analyses explored relationships between amatuximab exposure and overall survival (OS), progression-free survival (PFS) and safety. Alternative amatuximab dosing regimens were explored with simulations using population PK and parametric survival models.
Results
Amatuximab PK was best described by a two-compartment model with parallel linear and nonlinear elimination pathways. Body weight and an antidrug antibodies reaction with the titer >64 affected volume of distribution and clearance, respectively. Exposure–response analyses demonstrated that the amatuximab exposure (
C
min
) showed a significant effect on OS (log-rank test,
P
= 0.0202). For patients with amatuximab
C
min
above the median (38.2 μg/mL), the median OS was 583 days (90 % CI 418 –NE). For patients with
C
min
≤ 38.2 μg/mL, the median OS was 375 days (90 % CI 325–486). The amatuximab exposure showed similar significant effect on PFS. Exposure–response analysis for adverse events did not reveal any relationship.
Conclusions
In patients with MPM, higher amatuximab exposure in combination with chemotherapy was shown to be associated with longer OS, supporting evaluation of more frequent dosing in future trials to achieve higher exposure and subsequently longer OS. |
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AbstractList | Purpose To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural mesothelioma (MPM) receiving amatuximab with pemetrexed and cisplatin. Methods A nonlinear mixed effects PK model was built using data from all of the amatuximab studies conducted to date. Patients received amatuximab alone or in combination with chemotherapy. The influence of demographic, laboratory and disease characteristics on PK parameters was assessed. Exposure-response analyses explored relationships between amatuximab exposure and overall survival (OS), progression-free survival (PFS) and safety. Alternative amatuximab dosing regimens were explored with simulations using population PK and parametric survival models. Results Amatuximab PK was best described by a two-compartment model with parallel linear and nonlinear elimination pathways. Body weight and an antidrug antibodies reaction with the titer >64 affected volume of distribution and clearance, respectively. Exposure-response analyses demonstrated that the amatuximab exposure (C ^sub min^) showed a significant effect on OS (log-rank test, P = 0.0202). For patients with amatuximab C ^sub min^ above the median (38.2 [mu]g/mL), the median OS was 583 days (90 % CI 418 -NE). For patients with C ^sub min^ [less than or equal to] 38.2 [mu]g/mL, the median OS was 375 days (90 % CI 325-486). The amatuximab exposure showed similar significant effect on PFS. Exposure-response analysis for adverse events did not reveal any relationship. Conclusions In patients with MPM, higher amatuximab exposure in combination with chemotherapy was shown to be associated with longer OS, supporting evaluation of more frequent dosing in future trials to achieve higher exposure and subsequently longer OS. To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural mesothelioma (MPM) receiving amatuximab with pemetrexed and cisplatin. A nonlinear mixed effects PK model was built using data from all of the amatuximab studies conducted to date. Patients received amatuximab alone or in combination with chemotherapy. The influence of demographic, laboratory and disease characteristics on PK parameters was assessed. Exposure-response analyses explored relationships between amatuximab exposure and overall survival (OS), progression-free survival (PFS) and safety. Alternative amatuximab dosing regimens were explored with simulations using population PK and parametric survival models. Amatuximab PK was best described by a two-compartment model with parallel linear and nonlinear elimination pathways. Body weight and an antidrug antibodies reaction with the titer >64 affected volume of distribution and clearance, respectively. Exposure-response analyses demonstrated that the amatuximab exposure (C sub(min)) showed a significant effect on OS (log-rank test, P = 0.0202). For patients with amatuximab C sub(min) above the median (38.2 mu g/mL), the median OS was 583 days (90 % CI 418 -NE). For patients with C sub(min) less than or equal to 38.2 mu g/mL, the median OS was 375 days (90 % CI 325-486). The amatuximab exposure showed similar significant effect on PFS. Exposure-response analysis for adverse events did not reveal any relationship. In patients with MPM, higher amatuximab exposure in combination with chemotherapy was shown to be associated with longer OS, supporting evaluation of more frequent dosing in future trials to achieve higher exposure and subsequently longer OS. To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural mesothelioma (MPM) receiving amatuximab with pemetrexed and cisplatin. A nonlinear mixed effects PK model was built using data from all of the amatuximab studies conducted to date. Patients received amatuximab alone or in combination with chemotherapy. The influence of demographic, laboratory and disease characteristics on PK parameters was assessed. Exposure-response analyses explored relationships between amatuximab exposure and overall survival (OS), progression-free survival (PFS) and safety. Alternative amatuximab dosing regimens were explored with simulations using population PK and parametric survival models. Amatuximab PK was best described by a two-compartment model with parallel linear and nonlinear elimination pathways. Body weight and an antidrug antibodies reaction with the titer >64 affected volume of distribution and clearance, respectively. Exposure-response analyses demonstrated that the amatuximab exposure (C min) showed a significant effect on OS (log-rank test, P = 0.0202). For patients with amatuximab C min above the median (38.2 μg/mL), the median OS was 583 days (90 % CI 418 -NE). For patients with C min ≤ 38.2 μg/mL, the median OS was 375 days (90 % CI 325-486). The amatuximab exposure showed similar significant effect on PFS. Exposure-response analysis for adverse events did not reveal any relationship. In patients with MPM, higher amatuximab exposure in combination with chemotherapy was shown to be associated with longer OS, supporting evaluation of more frequent dosing in future trials to achieve higher exposure and subsequently longer OS. Purpose To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural mesothelioma (MPM) receiving amatuximab with pemetrexed and cisplatin. Methods A nonlinear mixed effects PK model was built using data from all of the amatuximab studies conducted to date. Patients received amatuximab alone or in combination with chemotherapy. The influence of demographic, laboratory and disease characteristics on PK parameters was assessed. Exposure–response analyses explored relationships between amatuximab exposure and overall survival (OS), progression-free survival (PFS) and safety. Alternative amatuximab dosing regimens were explored with simulations using population PK and parametric survival models. Results Amatuximab PK was best described by a two-compartment model with parallel linear and nonlinear elimination pathways. Body weight and an antidrug antibodies reaction with the titer >64 affected volume of distribution and clearance, respectively. Exposure–response analyses demonstrated that the amatuximab exposure ( C min ) showed a significant effect on OS (log-rank test, P = 0.0202). For patients with amatuximab C min above the median (38.2 μg/mL), the median OS was 583 days (90 % CI 418 –NE). For patients with C min ≤ 38.2 μg/mL, the median OS was 375 days (90 % CI 325–486). The amatuximab exposure showed similar significant effect on PFS. Exposure–response analysis for adverse events did not reveal any relationship. Conclusions In patients with MPM, higher amatuximab exposure in combination with chemotherapy was shown to be associated with longer OS, supporting evaluation of more frequent dosing in future trials to achieve higher exposure and subsequently longer OS. |
Author | Maltzman, Julia D. Wallin, Bruce A. Wustner, Jason Gupta, Anubha Hussein, Ziad Hassan, Raffit |
AuthorAffiliation | 1 Clinical Pharmacology, Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, UK 3 Thoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA 2 Morphotek, Inc., Exton, PA, USA 4 Former Employee of Morphotek, Inc., Exton, PA, USA |
AuthorAffiliation_xml | – name: 4 Former Employee of Morphotek, Inc., Exton, PA, USA – name: 2 Morphotek, Inc., Exton, PA, USA – name: 3 Thoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA – name: 1 Clinical Pharmacology, Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, UK |
Author_xml | – sequence: 1 givenname: Anubha surname: Gupta fullname: Gupta, Anubha organization: Clinical Pharmacology, Eisai Limited, European Knowledge Centre – sequence: 2 givenname: Ziad surname: Hussein fullname: Hussein, Ziad email: ziad_hussein@eisai.net organization: Clinical Pharmacology, Eisai Limited, European Knowledge Centre – sequence: 3 givenname: Raffit surname: Hassan fullname: Hassan, Raffit organization: Thoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health – sequence: 4 givenname: Jason surname: Wustner fullname: Wustner, Jason organization: Morphotek, Inc – sequence: 5 givenname: Julia D. surname: Maltzman fullname: Maltzman, Julia D. organization: Former Employee of Morphotek, Inc – sequence: 6 givenname: Bruce A. surname: Wallin fullname: Wallin, Bruce A. organization: Morphotek, Inc |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26898299$$D View this record in MEDLINE/PubMed |
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Keywords | Monoclonal antibody Malignant pleural mesothelioma Population pharmacokinetic/pharmacodynamic modeling Amatuximab |
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To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant... To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant pleural... Purpose To characterize amatuximab pharmacokinetics (PK) and the relationship of amatuximab exposure with response in patients with unresectable malignant... |
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SubjectTerms | Adult Aged Aged, 80 and over Antibodies, Monoclonal - pharmacokinetics Antibodies, Monoclonal - therapeutic use Cancer Research Disease-Free Survival Female Humans Lung Neoplasms - drug therapy Lung Neoplasms - mortality Male Medicine Medicine & Public Health Mesothelioma - drug therapy Mesothelioma - mortality Mesothelioma, Malignant Middle Aged Models, Biological Oncology Original Article Pharmacology/Toxicology Pleural Neoplasms - drug therapy Pleural Neoplasms - mortality |
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Title | Population pharmacokinetics and exposure–response relationship of amatuximab, an anti-mesothelin monoclonal antibody, in patients with malignant pleural mesothelioma and its application in dose selection |
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