Pascal Chanu
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View article: Disease Modeling and External Model Evaluation Through Clinical Data Sharing Platform for <scp>HR</scp>+/<scp>HER2</scp>− Breast Cancer
Disease Modeling and External Model Evaluation Through Clinical Data Sharing Platform for <span>HR</span>+/<span>HER2</span>− Breast Cancer Open
Predictive models for disease progression are valuable for clinical trial design and interpretation; however, suitable data are needed for the development of such models. This study aimed to develop a Tumor Growth Inhibition‐Overall Surviv…
View article: Use of Real‐World Claims Data to Assess the Prevalence of Concomitant Medications to Inform Drug–Drug Interaction Risk in Target Patient Populations
Use of Real‐World Claims Data to Assess the Prevalence of Concomitant Medications to Inform Drug–Drug Interaction Risk in Target Patient Populations Open
A common issue in clinical drug development involves drug–drug interactions (DDI) that may lead to altered drug exposure and subsequent altered safety and efficacy of an investigational drug or concomitant medications (conmeds) in the targ…
View article: Population Pharmacokinetics and Exposure‐Response of Subcutaneous Atezolizumab in Patients With Non‐Small Cell Lung Cancer
Population Pharmacokinetics and Exposure‐Response of Subcutaneous Atezolizumab in Patients With Non‐Small Cell Lung Cancer Open
IMscin001 is a two‐part dose‐finding (Phase Ib) and ‐confirmation (Phase III) study to evaluate atezolizumab pharmacokinetics of subcutaneous (SC) compared with intravenous (IV) administration in patients with locally advanced or metastati…
View article: Mechanistic Learning of Tumor and Blood Marker Dynamics Improves Survival Prediction in NSCLC Patients Treated with Atezolizumab
Mechanistic Learning of Tumor and Blood Marker Dynamics Improves Survival Prediction in NSCLC Patients Treated with Atezolizumab Open
BackgroundPredicting overall survival (OS) in non-small cell lung cancer (NSCLC) is essential for clinical decision-making and drug development. While tumor and blood test markers kinetics are intrinsically linked, their joint dynamics and…
View article: A Novel Step‐Up Dosage Regimen for Enhancing the Benefit‐to‐Risk Ratio of Mosunetuzumab in Relapsed or Refractory Follicular Lymphoma
A Novel Step‐Up Dosage Regimen for Enhancing the Benefit‐to‐Risk Ratio of Mosunetuzumab in Relapsed or Refractory Follicular Lymphoma Open
Mosunetuzumab, a T‐cell engaging bispecific antibody targeting CD20xCD3, is approved for treating relapsed/refractory follicular lymphoma. This research supports the approved intravenous clinical dose regimen, summarizing the exposure–resp…
View article: Expanding the use of real‐world data through the development of user‐friendly tools to support drug development: Example of an organ impairment dashboard
Expanding the use of real‐world data through the development of user‐friendly tools to support drug development: Example of an organ impairment dashboard Open
Real-world data (RWD), and more specifically electronic health record (EHR) data, have gained increasing interest and utilization in the pharmaceutical industry over the past few years, especially given their ability to support decision-ma…
View article: Population pharmacokinetics and CD20 binding dynamics for mosunetuzumab in relapsed/refractory B‐cell non‐Hodgkin lymphoma
Population pharmacokinetics and CD20 binding dynamics for mosunetuzumab in relapsed/refractory B‐cell non‐Hodgkin lymphoma Open
Mosunetuzumab (Mosun) is a CD20xCD3 T‐cell engaging bispecific antibody that redirects T cells to eliminate malignant B cells. The approved step‐up dose regimen of 1/2/60/30 mg IV is designed to mitigate cytokine release syndrome (CRS) and…
View article: Tumor growth and overall survival modeling to support decision making in phase Ib/II trials: A comparison of the joint and two‐stage approaches
Tumor growth and overall survival modeling to support decision making in phase Ib/II trials: A comparison of the joint and two‐stage approaches Open
Model‐based tumor growth inhibition (TGI) metrics are increasingly used to predict overall survival (OS) data in Phase III immunotherapy clinical trials. However, there is still a lack of understanding regarding the differences between two…
View article: Mechanistic modelling of tumor kinetics coupled with biomarker dynamics for survival prediction in non-small cell lung cancer patients
Mechanistic modelling of tumor kinetics coupled with biomarker dynamics for survival prediction in non-small cell lung cancer patients Open
International audience
View article: Population Pharmacokinetics and CD20 Binding Dynamics for Mosunetuzumab in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL)
Population Pharmacokinetics and CD20 Binding Dynamics for Mosunetuzumab in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL) Open
Introduction: Mosunetuzumab (Mosun) is a CD20xCD3 T-cell engaging bispecific antibody that redirects T cells to eliminate malignant B cells. Clinical data from GO29781 (NCT02500407), a Phase I/II, open-label, multicenter dose-escalation an…
View article: Multiple Myeloma Disease Model to Predict PFS Outcomes across Lines of Therapy, an Analysis Based on Commpass Observational Study
Multiple Myeloma Disease Model to Predict PFS Outcomes across Lines of Therapy, an Analysis Based on Commpass Observational Study Open
Introduction Multiple Myeloma (MM) remains incurable despite advances in treatment. Model-based approaches based on tumor dynamics have successfully been used to optimize drug-development in oncology. Model-derived tumor dynamics also call…
View article: Correction: Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Correction: Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
In the original version of this article (1), the authors stated that they calculated geometric mean ratios (GMR) in the text, tables, figures, and supplementary data; however, the published values were the ratios of medians (MedR). The lab…
View article: Supplementary Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Supplementary Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Supplementary Tables
View article: Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Purpose:Model-based tumor growth inhibition (TGI) metrics are increasingly incorporated into go/no-go decisions in early clinical studies. To apply this methodology to new investigational combinations requires independent evaluation of TGI…
View article: Supplementary Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Supplementary Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Supplementary Tables
View article: Clinical Pharmacology Applications of <scp>Real‐World</scp> Data and <scp>Real‐World</scp> Evidence in Drug Development and Approval–An Industry Perspective
Clinical Pharmacology Applications of <span>Real‐World</span> Data and <span>Real‐World</span> Evidence in Drug Development and Approval–An Industry Perspective Open
Since the 21st Century Cures Act was signed into law in 2016, real‐world data (RWD) and real‐world evidence (RWE) have attracted great interest from the healthcare ecosystem globally. The potential and capability of RWD/RWE to inform regul…
View article: Modeling Alzheimer's disease progression utilizing clinical trial and ADNI data to predict longitudinal trajectory of CDR‐SB
Modeling Alzheimer's disease progression utilizing clinical trial and ADNI data to predict longitudinal trajectory of CDR‐SB Open
There is strong interest in developing predictive models to better understand individual heterogeneity and disease progression in Alzheimer's disease (AD). We have built upon previous longitudinal AD progression models, using a nonlinear, …
View article: Supplementary Data TS1 from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Supplementary Data TS1 from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Supplementary Tables
View article: Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Purpose:Model-based tumor growth inhibition (TGI) metrics are increasingly incorporated into go/no-go decisions in early clinical studies. To apply this methodology to new investigational combinations requires independent evaluation of TGI…
View article: Supplementary Data TS1 from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Supplementary Data TS1 from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Supplementary Tables
View article: Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Data from Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Purpose:Model-based tumor growth inhibition (TGI) metrics are increasingly incorporated into go/no-go decisions in early clinical studies. To apply this methodology to new investigational combinations requires independent evaluation of TGI…
View article: Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150
Tumor Dynamic Model-Based Decision Support for Phase Ib/II Combination Studies: A Retrospective Assessment Based on Resampling of the Phase III Study IMpower150 Open
Purpose: Model-based tumor growth inhibition (TGI) metrics are increasingly incorporated into go/no-go decisions in early clinical studies. To apply this methodology to new investigational combinations requires independent evaluation of TG…
View article: Development of a pediatric physiologically-based pharmacokinetic model to support recommended dosing of atezolizumab in children with solid tumors
Development of a pediatric physiologically-based pharmacokinetic model to support recommended dosing of atezolizumab in children with solid tumors Open
Background: Atezolizumab has been studied in multiple indications for both pediatric and adult patient populations. Generally, clinical studies enrolling pediatric patients may not collect sufficient pharmacokinetic data to characterize th…
View article: Real‐world data prognostic model of overall survival in patients with advanced <scp>NSCLC</scp> receiving anti‐<scp>PD</scp>‐1/<scp>PD‐L1</scp> immune checkpoint inhibitors as second‐line monotherapy
Real‐world data prognostic model of overall survival in patients with advanced <span>NSCLC</span> receiving anti‐<span>PD</span>‐1/<span>PD‐L1</span> immune checkpoint inhibitors as second‐line monotherapy Open
Background and aim The objective of this retrospective, observational, noninterventional cohort study was to investigate prognostic factors of overall survival (OS) in patients with advanced non‐small cell lung cancer (aNSCLC) and to devel…
View article: Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer
Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer Open
Intravenous (IV) atezolizumab is approved for non–small cell lung and other cancers. Subcutaneous (SC) atezolizumab coformulated with recombinant human hyaluronidase, a permeation enhancer for SC dispersion and absorption, is being develop…