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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Veröffentlicht in:Clinical and translational science 2019-09, Vol.12 (5), p.450-458
Hauptverfasser: Baverel, Paul, Roskos, Lorin, Tatipalli, Manasa, Lee, Nancy, Stockman, Paul, Taboada, Maria, Vicini, Paolo, Horgan, Kevin, Narwal, Rajesh
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Sprache:eng
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Zusammenfassung: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