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

Year: 2022
Type: article
Abstract: 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.
DOI: 10.3389/fonc.2022.859892
Authors: Stephen V. Liu, Misako Nagasaka, Victoria Stefaniak, Kristi Gruver, Yong Lin, David Ferry, Mark A. Socinski, Li Zhang
Institutions: Georgetown University, Georgetown Lombardi Comprehensive Cancer Center, University of California, Irvine, Eli Lilly (United States), AdventHealth Orlando, AdventHealth, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China
Language: English
Field: Medicine
Open Access status: gold
Estimated APC paid: $2,950
OpenAlex ID: W4281740508
FWCI: 0.484
Cites: 46
Cited by: 8
Related to: 10