On November 12, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported 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 (Press release, Natera, NOV 12, 2024, View Source [SID1234648231]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (ASCO) (Free ASCO Whitepaper) 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.