Natera Announces Completion of Signatera™ Analysis from the CALGB (Alliance)/SWOG 80702 Randomized, Phase III Clinical Trial in Colorectal Cancer

First-of-its-kind study of >1K patients evaluating the impact of adjuvant treatment escalation in patients tested with Signatera™; results to be presented at ASCO GI in Jan. 2025

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical trial. CALGB (Alliance)/SWOG 80702 evaluated the benefit of adding celecoxib to FOLFOX in postoperative treatment of stage III colorectal cancer (CRC) in a biomarker unselected population.

This pre-specified analysis includes 1,011 CRC patients with available post-surgical plasma samples and investigates Signatera’s ability to identify a subgroup of patients who may benefit from adding celecoxib to FOLFOX. Disease free survival (DFS) and overall survival (OS) are the study’s primary and secondary endpoints, respectively.

Additional details on CALGB (Alliance)/SWOG 80702

In the CALGB (Alliance)/SWOG 80702 trial, patients were randomized to receive standard-of-care adjuvant chemotherapy FOLFOX (+/-) celecoxib, a non-steroidal anti-inflammatory drug (NSAID). Although the results showed that the addition of celecoxib did not significantly improve disease-free survival¹, NSAIDs have shown promise in benefiting certain subpopulations in CRC, including reducing the risk of developing precancerous colon polyps. In addition, NSAIDs are typically well-tolerated, widely available, and generally low-cost.

“We see this trial as one of the most important in the space given its size, randomized design, and indication,” said Alexey Aleshin, MD, MBA, general manager of oncology and chief medical officer of Natera. “There is a clear need for additional adjuvant treatment options for patients with colorectal cancer as there has not been a new drug approval in the space in over 20 years. We are hopeful that Signatera-guided therapy selection can help open the door to effective treatment options in CRC, personalized to the patients who are most likely to benefit.”

Results have been accepted as a late-breaking abstract to be shared at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI), which takes place from Jan. 23-25, 2024 in San Francisco, CA.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 90 peer-reviewed papers.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 200 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 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.

References

1. Meyerhardt JA, Shi Q, Fuchs CS, et al. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA. 2021;325(13):1277-1286. doi:10.1001/jama.2021.2454