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

Stephen V Liu; Misako Nagasaka; Victoria Stefaniak; Kristi Gruver; Yong Lin; David Ferry; Mark A Socinski; Li Zhang

doi:10.3389/fonc.2022.859892

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

Front Oncol. 2022 Jun 10:12:859892. doi: 10.3389/fonc.2022.859892. eCollection 2022.

Authors

Stephen V Liu¹, Misako Nagasaka², Victoria Stefaniak³, Kristi Gruver³, Yong Lin³, David Ferry³, Mark A Socinski⁴, Li Zhang⁵

Affiliations

¹ Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, United States.
² Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Irvine, CA, United States.
³ Oncology, Eli Lilly and Company, Indianapolis, IN, United States.
⁴ Hematology and Oncology, AdventHealth Cancer Institute, Orlando, FL, United States.
⁵ Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.

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.

Keywords: Asian; ORIENT-11; chemo-immunotherapy; immunotherapy; non-small cell lung cancer; sintilimab.