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, November 12, 2024--(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.