On January 22, 2022 Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, reported that new data recently presented on the clinical utility of Signatera, its personalized and tumor-informed molecular residual disease (MRD) test, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2022 Gastrointestinal Cancers Symposium (ASCO GI) (Press release, Natera, JAN 22, 2022, View Source [SID1234606701]). The oral presentation included an updated analysis from the landmark CIRCULATE-Japan trial analyzing a cohort of colorectal cancer (CRC) patients.

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More than 3,000 CRC patients are now enrolled in CIRCULATE-Japan, the largest prospective, multi-center, 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 novel findings that were presented at the conference:

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 (p-value of .63).
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%. This sensitivity analysis included over 5 times more cancer recurrences than previously reported in Reinert, et. al.1

"Definitive evidence has now been presented that personalized MRD testing can guide adjuvant treatment decisions, particularly for MRD-positive patients who clearly benefit from adjuvant chemotherapy," said the CIRCULATE-Japan study’s principal investigator, Dr. Takayuki Yoshino, of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "We see these results as an important step forward in establishing MRD-guided adjuvant therapy as the standard of care for colorectal cancer patients worldwide."

"Current guidelines recommend combination chemotherapy for all patients with stage III CRC, yet it is known that up to 40% are cured by surgery alone. Our study demonstrates that MRD testing can help stratify and predict which patients are likely to benefit from systemic therapy," said Alexey Aleshin, M.D., VP of oncology medical affairs at Natera. "We are extremely pleased with these groundbreaking results from CIRCULATE-Japan and are optimistic they may change practice guidelines."

The full presentation, as shown at ASCO (Free ASCO Whitepaper) GI, is available here.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.