Exposure–Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status

Tremelimumab, an anti‐cytotoxic T‐lymphocyte antigen‐4 monoclonal antibody that enhances T‐cell activation, was evaluated in a randomized, double‐blind, placebo‐controlled, phase IIb study (NCT01843374) in patients with unresectable malignant mesothelioma. The study demonstrated no clinically meanin...

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Bibliographic Details
Published in:Clinical and translational science 2019-09, Vol.12 (5), p.450-458
Main Authors: Baverel, Paul, Roskos, Lorin, Tatipalli, Manasa, Lee, Nancy, Stockman, Paul, Taboada, Maria, Vicini, Paolo, Horgan, Kevin, Narwal, Rajesh
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal, Humanized - pharmacokinetics
Antibodies, Monoclonal, Humanized - therapeutic use
Cancer therapies
Cell activation
Chemotherapy
Confounding Factors, Epidemiologic
Cytokines
Cytotoxicity
Employees
Exposure
Humans
Immunotherapy
Kaplan-Meier Estimate
Ligands
Lung Neoplasms - drug therapy
Lymphocytes
Medical prognosis
Medical research
Melanoma
Mesothelioma
Mesothelioma - drug therapy
Mesothelioma, Malignant
Metastasis
Models, Biological
Monoclonal antibodies
Response rates
Risk Factors
Statistical analysis
Studies
Survival
Targeted cancer therapy
Tumors
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Summary:Tremelimumab, an anti‐cytotoxic T‐lymphocyte antigen‐4 monoclonal antibody that enhances T‐cell activation, was evaluated in a randomized, double‐blind, placebo‐controlled, phase IIb study (NCT01843374) in patients with unresectable malignant mesothelioma. The study demonstrated no clinically meaningful differences in overall survival (OS). The objective of this analysis was to evaluate the relationship of exposure with OS. A population pharmacokinetic (PK) model adequately described the PK data. Three factors (sex, C‐reactive protein, and baseline tumor size) were identified as statistically significant PK predictors (P 
ISSN:1752-8054
1752-8062
1752-8062
DOI:10.1111/cts.12633