KEY TAKEAWAYS
- ORIENT-11 (NCT03607539), Phase 3 study assessed the utilization of sintilimab in improving PFS.
- The study aimed to evaluate the efficacy and safety of sintilimab, pemetrexed, and platinum in treating NSCLC.
- Patients were randomly assigned the combination and a BIRC assessed their response.
- The study resulted in improved PFS, response rate, and response duration without significantly increasing toxicity.
The phase 3 ORIENT-11 study found that the combination of sintilimab, pemetrexed, and platinum improved progression-free survival (PFS) in patients with nonsquamous NSCLC (NCT03607539). Sintilimab, a PD-1 inhibitor, was added to chemotherapy, and similar to previous trials, it increased PFS, response rate, and response duration without significantly increasing toxicity. A blind independent radiographic review committee assessed the response (RECISTv.1.1).
The ORIENT-11 experiment was completely carried out in China, in contrast to earlier trials. To properly evaluate the efficacy and safety of data from international clinical trials, it is necessary to take into account both internal and extrinsic aspects.
Source: https://pubmed.ncbi.nlm.nih.gov/35756655/
Clinical trial:https://clinicaltrials.gov/ct2/show/NCT03607539
Liu, S. V., Nagasaka, M., Stefaniak, V., Gruver, K., Lin, Y., Ferry, D., Socinski, M. A., & Zhang, L. (2022). The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework. Frontiers in oncology, 12, 859892. https://doi.org/10.3389/fonc.2022.859892
