Importing oncology trials from China: a bridge over troubled waters?

Abstract

On Feb 10, 2022, the US Food and Drug Administration's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a clinical trial comparing chemotherapy plus sintilimab, an anti-PD-1 monoclonal antibody and member of the checkpoint inhibitor class, with chemotherapy alone as an initial treatment for metastatic non-small-cell lung cancer (NSCLC). 1 Roth LK Federal Register Vol. 86, No. 236. https://www.govinfo.gov/content/pkg/FR-2021-12-13/pdf/2021-26923.pdfDate: Dec 13, 2021 Date accessed: January 28, 2022 Google Scholar Done exclusively in China, the trial's design, patient population, and statistical analysis closely resembles landmark NSCLC trials that established checkpoint inhibitors as part of initial treatment regimens several years ago. 2 Yang Y Wang Z Fang J et al. Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous NSCLC: a randomized, double-blind, phase 3 study (Oncology pRogram by InnovENT anti-PD-1-11). J Thorac Oncol. 2020; 15: 1636-1646 Google Scholar Rather than an isolated case, this application reflects an increasing number of oncology development programmes based solely or predominantly on clinical data from China, with at least 25 applications from China in drug development phases, planned to be submitted, or currently under review. 3 Beaver JA Pazdur R The wild west of checkpoint inhibitor development. N Engl J Med. 2021; (published online Dec 15.)https://doi.org/10.1056/NEJMp2116863 Google Scholar