Press release
Natera Announces Publication of Signatera™ Analysis from Randomized, Phase III CALGB (Alliance)/SWOG 80702 Study in Colorectal Cancer
JAMA Oncology study highlights that Signatera-positive patients treated with celecoxib and conventional chemotherapy experienced a >40% reduction in risk of
About this update from Natera, Inc.
[{"type":"text","content":"\nJAMA Oncology study highlights that Signatera-positive patients treated with celecoxib and conventional chemotherapy experienced a >40% reduction in risk of death, whereas Signatera-negative patients derived no significant benefit\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of findings from the randomized, phase III CALGB (Alliance)/SWOG 80702 study in JAMA Oncology. This publication builds on the initial presentation of results at the 2025 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) earlier this year.\n\nCALGB (Alliance)/SWOG 80702 assessed the predictive value of postoperative personalized circulating tumor DNA (ctDNA) in patients with stage III colorectal cancer (CRC). The pre-specified post-hoc analysis included 940 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX +/- celecoxib, a non-steroidal anti-inflammatory drug (NSAID). Key findings included:\n\n\nAdding celecoxib to conventional chemotherapy in Signatera-positive patients, after surgery reduced the risk of cancer recurrence and death by ~40%. Celecoxib improved disease-free survival (DFS) (adjusted HR=0.61, 95% CI 0.42-0.89; 3-year 41.0% vs. 22.6%) and overall survival (OS) (adjusted HR=0.62, 95% CI 0.40-0.96; 5-year: 61.6% vs. 39.9%) compared to placebo in Signatera-positive patients.\n\n\n\nCelecoxib benefit in Signatera-positive patients was independent of demographic, pathologic or molecular factors, including PIK3CA status, further defining a patient population who may benefit from the addition to adjuvant treatment. Celecoxib improved DFS of Signatera-positive patients for both PIK3CA wild-type (adjusted HR=0.64, 95% CI 0.42-0.98) and PIK3CA altered (adjusted HR=0.19, 95% CI 0.06-0.58) tumors. No benefit was observed in Signatera-negative patients (PIK3CA wild-type adjusted HR=0.80, 95% CI 0.55-1.18; PIK3CA altered HR=0.85, 95% CI 0.33-2.24).\n\n\n\nNew analysis showed statistical significance in the interaction between MRD status and treatment randomization. In 66% of patients with plasma and DNA samples that would pass minimum QC criteria for Signatera analysis in the CLIA lab, analysis showed an even stronger benefit for adjuvant celecoxib than in the overall cohor...