A5018798462- Lung Cancer Treatments and Mutations
- Cancer Immunotherapy and Biomarkers
- Statistical Methods in Clinical Trials
- Monoclonal and Polyclonal Antibodies Research
- Biosimilars and Bioanalytical Methods
- Colorectal Cancer Treatments and Studies
- Cancer Genomics and Diagnostics
- COVID-19 Clinical Research Studies
- Mathematical Biology Tumor Growth
- Long-Term Effects of COVID-19
- SARS-CoV-2 and COVID-19 Research
- Organ and Tissue Transplantation Research
- Pancreatic and Hepatic Oncology Research
- HER2/EGFR in Cancer Research
- Bioinformatics and Genomic Networks
- CAR-T cell therapy research
- Machine Learning in Healthcare
- Immunotherapy and Immune Responses
- Melanoma and MAPK Pathways
- COVID-19 Impact on Reproduction
- Cancer Treatment and Pharmacology
- Brain Metastases and Treatment
- Smoking Behavior and Cessation
- Advanced Drug Delivery Systems
- Drug Solubulity and Delivery Systems
Hôpital Foch
2022-2024
International Drug Development
2023
Weatherford College
2023
Université de Versailles Saint-Quentin-en-Yvelines
2022
Collaborative Group (United States)
2020
Génétique Animale et Biologie Intégrative
2017
HealthInsight
2015
To determine the exposure-response (ER) relationships between atezolizumab exposure and efficacy or safety in patients with advanced non-small cell lung cancer (NSCLC) urothelial carcinoma (UC) to identify alternative dosing regimens.ER analyses were conducted using pooled NSCLC UC data from phase 1 3 studies (PCD4989g, OAK, IMvigor211; ClinicalTrials.gov IDs, NCT01375842, NCT02008227, NCT02302807, respectively). Objective response rate, overall survival, adverse events evaluated vs...
Abstract 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 designed mitigate cytokine release syndrome (CRS) and maximize efficacy in early cycles. A population pharmacokinetic (popPK) model was developed from 439 patients with relapsed/refractory B‐Cell Non‐Hodgkin lymphoma receiving Mosun monotherapy, including fixed dosing (0.05–2.8 every 3 weeks (q3w)) Cycle 1...
Bevacizumab is approved for various cancers. This analysis aimed to comprehensively evaluate bevacizumab pharmacokinetics and the influence of patient variables on pharmacokinetics. Rich sparse serum concentrations were collected from Phase I through IV studies in early metastatic was given intravenously as single agent or combination with chemotherapy single- multiple-dose schedules. Model-building used 8943 1792 patients colon/colorectal, non-small cell lung, kidney, pancreatic, breast,...
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 recently completed Phase III trials effective immunotherapy. Patients and Methods: Data were extracted from IMpower150, a positive, randomized, study first-line therapy 1,202 patients with non–small cell lung cancer. We resampled baseline characteristics...
ABSTRACT IMscin001 is a two‐part dose‐finding (Phase Ib) and ‐confirmation III) study to evaluate atezolizumab pharmacokinetics of subcutaneous (SC) compared with intravenous (IV) administration in patients locally advanced or metastatic non‐small cell lung cancer (NSCLC). The objectives the current analyses were characterize population (popPK) determine relationship between exposure safety efficacy endpoints IMscin001. A previously validated IV popPK model was extended add SC absorption...
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-stage or joint modeling methods leverage I/II trial and help early decision-making. A recent study showed that TGI such as rate constant K
Abstract Intravenous (IV) atezolizumab is approved for non–small cell lung and other cancers. Subcutaneous (SC) coformulated with recombinant human hyaluronidase, a permeation enhancer SC dispersion absorption, being developed to improve treatment options, reduce burden, increase efficiency patients practitioners. IMscin001 (NCT03735121), 2‐part, open‐label, global, multicenter, phase 1b/3 study, evaluating the pharmacokinetics (PK), safety, efficacy of atezolizumab. The part 1 (phase 1b)...
Absolute uterus factor infertility, whether congenital or acquired, renders the woman unable to carry a child. Although transplantation (UTx) is being increasingly performed as non-vital procedure address this unfortunate condition, immunosuppression required presents risks that are further compounded by pregnancy and during puerperium period. These vulnerabilities require avoidance of SARS-CoV-2 infection in pregnant UTx recipients especially third trimester, accumulating evidence reveals...
We assess the longitudinal tumor growth inhibition (TGI) metrics and overall survival (OS) predictions applied to patients with advanced biliary tract cancer (BTC) enrolled in IMbrave151 a multicenter randomized phase II, double-blind, placebo-controlled trial evaluating efficacy safety of atezolizumab or without bevacizumab combination cisplatin plus gemcitabine. Tumor rate (KG) was estimated for IMbrave151. A pre-existing TGI-OS model hepatocellular carcinoma IMbrave150 modified include...
Although tocilizumab treatment in severe and critical coronavirus disease 2019 (COVID-19) patients has proven its efficacy at the clinical level, there is little evidence supporting effect of short-term use interleukin-6 receptor blocking therapy on B cell sub-populations cross-neutralization SARS-CoV-2 variants convalescent COVID-19 patients. We performed immunological profiling 69 tocilizumab-treated non-treated total. observed that SARS-CoV-2-specific IgG1 titers depended severity but not...
Characterizing nicotine pharmacokinetics is challenging in the presence of background exposure. We performed a combined retrospective population pharmacokinetic analysis 8 trials, including exposure to Tobacco Heating System and cigarettes (both inhaled), nasal spray oral gum.Data from 4 single product use trials were used develop model with Phoenix® NLME™ derive parameters. Data separate ad libitum studies for external validation. A total 702 healthy adult smokers (54% males; 21-66 years...
Two-stage and joint modeling approaches are the two main to investigate link between longitudinal tumor size data overall survival (OS) anticipate clinical trial outcome. We here used a large database composed of one phase II five III trials evaluating atezolizumab (an immunotherapy) in monotherapy or combination with chemotherapies 3699 patients non-small cell lung cancer evaluate differences both terms parameter estimates, magnitude covariate effects, ability predict OS. Although two-stage...
Since 2017, women with absolute uterine infertility due to Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome have been eligible participate in a transplantation clinical trial conducted by Foch Hospital France. The aim of this study is assess the psychological state potential candidates, including recipients, their partners, and living-related donors.
Atezolizumab is approved as an intravenous (IV) infusion for use a single agent and in combination with other therapies number of indications. The objectives this publication are to characterize atezolizumab pharmacokinetics (PK) across indications the available clinical data from one phase I eight III studies, determine exposure-response (ER) relationships settings variety tumor types, provide safety support extension 840 mg q2w, 1200 q3w, 1680 q4w IV dosing regimens various settings....
Uterus transplantation (UTx) is a treatment option for women with absolute uterine factor infertility. More than 100 UTx procedures have been performed, and the procedure being accepted into clinical practice.1-3 However, rejection, which typically asymptomatic, occurs in approximately 60% of patients4; specific biomarkers function rejection are lacking.5 Current practice assessing graft involves cervical biopsies T-lymphocyte infiltration between stroma epithelium appraising perivascular...
2573 Background: Cobimetinib (COBI), an inhibitor of mitogen-activated protein kinases, when combined with vemurafenib (VEM) has been shown to significantly improve PFS (p < 0.001) over VEM alone in patients BRAF V600 mutated melanoma the Phase 3 study, coBRIM. This analysis aimed characterize COBI PK and evaluate impact clinically relevant covariates on exposure inform dosing. Methods: Plasma samples (n = 4886) were collected from 487 various solid tumors (mainly melanoma) clinical studies...
<div>Purpose:<p>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 recently completed Phase III trials effective immunotherapy.</p>Patients and Methods:<p>Data were extracted from IMpower150, a positive, randomized, study first-line therapy 1,202 patients with non–small cell lung cancer. We...
<div>AbstractPurpose:<p>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 recently completed Phase III trials effective immunotherapy.</p>Patients and Methods:<p>Data were extracted from IMpower150, a positive, randomized, study first-line therapy 1,202 patients with non–small cell lung...