Press release
Natera Presents Updated Analyses From ALTAIR Clinical Trial at ASCO GI
Study showed a statistically significant disease-free survival (DFS) benefit in all SignateraTM-positive patients following blinded central review AUSTIN,
About this update from Natera, Inc.
[{"type":"text","content":"\nStudy showed a statistically significant disease-free survival (DFS) benefit in all SignateraTM-positive patients following blinded central review\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that new data from the ALTAIR trial will be presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), taking place January 8-10, 2026.\n\n\nA new analysis will be presented from the randomized, double-blind, phase III ALTAIR clinical trial (NCT04457297). ALTAIR examined treatment on molecular recurrence (TOMR) with Trifluridine/Tipiracil (FTD/TPI) in Signatera-positive patients with stage I-IV colorectal cancer (CRC). This investigator-initiated analysis, based on a post-hoc blinded central radiographic review that resulted in the reclassification of a subset of cases, showed a statistically significant DFS benefit of FTD/TPI vs. placebo in all patients (median DFS 9.23 vs 5.55 months; HR: 0.75, 95% CI: 0.55-0.98; P=0.0406). Importantly, these findings represent a substantial update from the previously reported overall ALTAIR analysis, which showed a numerical DFS improvement that did not reach statistical significance in the full study population.\n\n\nIn addition to ALTAIR, Natera’s ASCO GI presentations include a large-scale study on Signatera velocity as a prognostic marker for relapse risk stratification. In the study, CRC patients whose Signatera levels doubled in one month or less experienced ~40% shorter recurrence free survival (RFS) vs patients with slower doubling time. The prognostic association between the rate of circulating tumor DNA (ctDNA) increase and recurrence risk remained significant for patients who received adjuvant chemotherapy, as well as those who did not. This data is specific to Natera’s quantification method, which uses mean tumor molecules (MTM) per mL of plasma.\n\n\n“Natera’s unmatched scale of evidence across tumor types uniquely positions the company to define ctDNA dynamics and translate them into meaningful biological insight and clinical action,” said Adham Jurdi, M.D., senior medical director of GI oncology at Natera. “We believe these capabilities, including TOMR approaches, can ultimately support more precise risk stratification and cancer management.”\n\n...