(RTTNews) - The Landmark CIRCULATE-Japan Study Showed Natera Inc.'s (NTRA) Signatera MRD Test is predictive of chemotherapy benefit in Colorectal Cancer.
More than 3,000 cohort of colorectal cancer or CRC patients are now enrolled in CIRCULATE-Japan, the largest prospective, multi-center, molecular residual disease or MRD-guided trial in CRC, using Signatera to monitor MRD status in patients with stage I-IV CRC up to 96 weeks post-surgery.
The latest analysis of more than 1,000 patients from the observational GALAXY arm of the study highlighted three findings that were presented at the American Society of Clinical Oncology's 2022 Gastrointestinal Cancers Symposium.
Signatera positivity is predictive of treatment benefit: patients who were MRD-positive at 4 weeks post-op benefited significantly from adjuvant chemotherapy (ACT), across all stages of disease.
Signatera-negative patients did not benefit from ACT: patients with high-risk stage II and stage III disease who were MRD-negative at 4 weeks post-op did not derive significant benefit from ACT.
Signatera dynamics during ACT is predictive of treatment benefit: 68% of ACT-treated patients cumulatively cleared their ctDNA by week 24 and had significantly better outcomes relative to those who remained ctDNA-positive, with a hazard ratio of 15.8.
In addition, the single time point post-surgical sensitivity of Signatera in stage II and III CRC was 67.6%. The sensitivity analysis included over 5 times more cancer recurrences than previously reported in Reinert et. al.
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