The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework

Sintilimab combined with pemetrexed and platinum met the primary endpoint of improving progression-free survival (PFS) as a first-line therapy for nonsquamous non-small cell lung cancer (NSCLC) in the phase 3 trial ORIENT-11 (NCT03607539). As seen in similar trials, the addition of sintilimab, a PD-...

Descripción completa

Detalles Bibliográficos
Autores principales: Liu, Stephen V., Nagasaka, Misako, Stefaniak, Victoria, Gruver, Kristi, Lin, Yong, Ferry, David, Socinski, Mark A., Zhang, Li
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Oncology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9226396/
https://www.ncbi.nlm.nih.gov/pubmed/35756655
http://dx.doi.org/10.3389/fonc.2022.859892
_version_ 1784733866271965184
author Liu, Stephen V.
Nagasaka, Misako
Stefaniak, Victoria
Gruver, Kristi
Lin, Yong
Ferry, David
Socinski, Mark A.
Zhang, Li
author_facet Liu, Stephen V.
Nagasaka, Misako
Stefaniak, Victoria
Gruver, Kristi
Lin, Yong
Ferry, David
Socinski, Mark A.
Zhang, Li
author_sort Liu, Stephen V.
collection PubMed
description Sintilimab combined with pemetrexed and platinum met the primary endpoint of improving progression-free survival (PFS) as a first-line therapy for nonsquamous non-small cell lung cancer (NSCLC) in the phase 3 trial ORIENT-11 (NCT03607539). As seen in similar trials, the addition of sintilimab, a PD-1 inhibitor, to chemotherapy improved the PFS without significantly worsening the toxicity, with improvements in response rate and duration of response. In contrast to previous trials, the ORIENT-11 trial was conducted completely in China. Both intrinsic and extrinsic factors are important to consider when reviewing foreign clinical trial data, as they may influence the efficacy and the safety outcomes. Here we discuss the applicability of ORIENT-11 clinical results to a Western population.
format Online
Article
Text
id pubmed-9226396
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-92263962022-06-25 The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework Liu, Stephen V. Nagasaka, Misako Stefaniak, Victoria Gruver, Kristi Lin, Yong Ferry, David Socinski, Mark A. Zhang, Li Front Oncol Oncology Sintilimab combined with pemetrexed and platinum met the primary endpoint of improving progression-free survival (PFS) as a first-line therapy for nonsquamous non-small cell lung cancer (NSCLC) in the phase 3 trial ORIENT-11 (NCT03607539). As seen in similar trials, the addition of sintilimab, a PD-1 inhibitor, to chemotherapy improved the PFS without significantly worsening the toxicity, with improvements in response rate and duration of response. In contrast to previous trials, the ORIENT-11 trial was conducted completely in China. Both intrinsic and extrinsic factors are important to consider when reviewing foreign clinical trial data, as they may influence the efficacy and the safety outcomes. Here we discuss the applicability of ORIENT-11 clinical results to a Western population. Frontiers Media S.A. 2022-06-10 /pmc/articles/PMC9226396/ /pubmed/35756655 http://dx.doi.org/10.3389/fonc.2022.859892 Text en Copyright © 2022 Liu, Nagasaka, Stefaniak, Gruver, Lin, Ferry, Socinski and Zhang https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Liu, Stephen V.
Nagasaka, Misako
Stefaniak, Victoria
Gruver, Kristi
Lin, Yong
Ferry, David
Socinski, Mark A.
Zhang, Li
The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework
title The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework
title_full The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework
title_fullStr The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework
title_full_unstemmed The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework
title_short The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework
title_sort applicability of the results in the asian population of orient-11 to a western population according to the ich-e5 framework
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9226396/
https://www.ncbi.nlm.nih.gov/pubmed/35756655
http://dx.doi.org/10.3389/fonc.2022.859892
work_keys_str_mv AT liustephenv theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT nagasakamisako theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT stefaniakvictoria theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT gruverkristi theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT linyong theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT ferrydavid theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT socinskimarka theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT zhangli theapplicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT liustephenv applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT nagasakamisako applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT stefaniakvictoria applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT gruverkristi applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT linyong applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT ferrydavid applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT socinskimarka applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework
AT zhangli applicabilityoftheresultsintheasianpopulationoforient11toawesternpopulationaccordingtotheiche5framework

Ejemplares similares