Landmark CIRCULATE-Japan Study Shows Natera's Signatera™ MRD Test is Predictive of Chemotherapy Benefit in Colorectal Cancer

AUSTIN, Texas, Jan. 22, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, today announced 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's 2022 Gastrointestinal Cancers Symposium (ASCO GI). The oral presentation included an updated analysis from the landmark CIRCULATE-Japan trial analyzing a cohort of colorectal cancer (CRC) patients.

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 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.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

Media: Kate Stabrawa, Communications, Natera, Inc., [email protected]

References

1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.

SOURCE Natera, Inc.

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