KEY TAKEAWAYS
- The phase III trial aimed to compare the efficacy of sintilimab monotherapy vs. standard adjuvant chemotherapy in dMMR stage III colon cancer pts.
- The primary endpoint is DFS. Secondary endpoints include OS, safety, toxicity, and QoL.
- The study will collect archived tumor and blood samples for correlation studies. Enrollment is ongoing.
Approximately 12% of stage III colon cancers have deficient mismatch repair (dMMR). Pembrolizumab showed significant improvement in progression-free survival (PFS) over chemotherapy in microsatellite instability (MSI-H)/dMMR metastatic colorectal cancer (mCRC) patients (pts) in KEYNOTE-177.
Researchers aimed to compare the efficacy of sintilimab monotherapy vs. standard adjuvant chemotherapy in dMMR stage III colon cancer pts.
The eligible pts should be 18 or above with fully resected stage III colon cancer, confirmed as dMMR/MSI-H, and ECOG performance status of 0-1. About 323 pts will be randomly assigned in an equal ratio to receive either sintilimab monotherapy (200 mg IV every 3 weeks for 8 cycles) or the CAPOX regimen (capecitabine, oxaliplatin for 4 or 8 cycles as per current standard practice). Adverse events(AEs) will be monitored during treatment and up to 30 days after (90 days for serious AEs), and they will be graded according to NCI CTCAE v4.0.
The primary endpoint is to assess 3-year disease-free survival (DFS) with the study designed to detect a hazard ratio (HR) of 0.56 for DFS with 80% power at a two-sided alpha level of 0.05. Secondary endpoints include overall survival (OS), safety, toxicity, and quality of life (QoL). Archived tumor tissue and blood samples will be gathered for correlative investigations. The enrollment for the study is still ongoing.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.TPS3637
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05236972
Zhenlin Hou, Wu Jiang, Jinghua Tang, Binyi Xiao, Yuan Li, Dandan Li, Xiaoshi Zhang, Zhi-Zhong Pan, and Peirong Ding. DOI:10.1200/JCO.2023.41.16_suppl.TPS3637 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS3637-TPS3637.
