Natera announced it will present updated analyses from its phase III ALTAIR colorectal cancer trial at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) scheduled for January 8‑10, 2026. The update, derived from a blinded central radiographic review, shows a statistically significant disease‑free survival (DFS) benefit for patients receiving Trifluridine/Tipiracil (FTD/TPI) versus placebo, with median DFS of 9.23 months versus 5.55 months (HR 0.75, 95% CI 0.55‑0.98, P = 0.0406).
The new data represent a substantial improvement over the trial’s initial analysis, which had shown a numerical DFS advantage that did not reach significance. The post‑hoc reclassification of cases in the central review was key to uncovering the benefit, underscoring the importance of rigorous imaging adjudication in ctDNA‑guided trials.
The findings reinforce the clinical utility of Natera’s Signatera MRD assay as a decision‑making tool for adjuvant therapy in stage I‑IV colorectal cancer. By demonstrating a clear DFS benefit in Signatera‑positive patients, the data support payer coverage discussions and could accelerate adoption of the assay in routine oncology practice.
In addition to the ALTAIR update, Natera will present data on Signatera velocity, a prognostic marker that shows patients whose ctDNA levels double within one month experience roughly 40% shorter recurrence‑free survival. These complementary analyses further expand the evidence base for the assay’s role in risk stratification and treatment tailoring.
Senior medical director Adham Jurdi said the company’s extensive data set positions Natera uniquely to translate ctDNA dynamics into actionable clinical insights. With an estimated 80% market share of the MRD testing market, the updated trial results strengthen Natera’s competitive advantage and support its strategy to expand reimbursement and clinical guideline inclusion.
The presentation at ASCO GI will provide the oncology community with the most comprehensive evidence to date on the impact of ctDNA‑guided therapy, potentially shaping future treatment standards and reimbursement policies for colorectal cancer.
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