Natera Presents Updated Analyses From ALTAIR Clinical Trial at ASCO GI

Study showed a statistically significant disease-free survival (DFS) benefit in all Signatera^TM-positive patients following blinded central review

AUSTIN, Texas–(BUSINESS WIRE)–Natera, 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.

A 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.

In 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.

“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.”

The full list of 14 presentations at ASCO GI includes:

January 8, 11:30 AM PT | Abstract # 440

Presenter: Sahar Forootan Sedigh

Tumor-informed ctDNA monitoring during surveillance for early detection of recurrence in patients with stage II/III esophageal cancer treated with chemoradiation

January 8, 11:30 AM PT | Abstract # 843

Presenter: Axel Grothey, M.D.

AI-assisted automated abstraction for enhanced patient insights in gastrointestinal cancers

January 8, 11:30 AM PT | Abstract # 814

Presenter: Gladys Magaly Rodriguez, M.D., MS

Characterization of DPYD variants across ancestries in a large real-world cohort of cancer patients

January 9, 11:30 AM PT | Abstract # 778

Presenter: Elishama Kanu, M.D., MA

Prognostic value of ctDNA monitoring in patients with resectable pancreatic ductal adenocarcinoma during surveillance

January 10, 7:00 AM PT | Abstract # 163

Presenter: George Q. Zhang, M.D., MPH

Physical activity and molecular residual disease (MRD) in stage III colon cancer: Findings from CALGB (Alliance)/SWOG 80702

January 10, 7:00 AM PT | Abstract # 216

Presenter: Saori Mishima, M.D., Ph.D.

Assessing adjuvant chemotherapy benefit in younger and older molecular residual disease-positive patients with stage II/III colorectal cancer

January 10, 7:00 AM PT | Abstract # 221

Presenter: Naoya Akazawa, M.D.

Prognostic value of presurgical circulating tumor DNA (ctDNA) levels and other clinical factors in colon cancer

January 10, 7:00 AM PT | Abstract # 220

Presenter: Koji Ando

Correlation between the timing of recurrence and circulating tumor DNA (ctDNA) doubling time in patients (pts) with resected colon cancer

January 10, 7:00 AM PT | Abstract # 153

Presenter: Kozo Kataoka, M.D., Ph.D.

Adjuvant mFOLFOXFIRI after curative-intent resection of oligometastatic colorectal cancer: Phase II FANTASTIC trial

January 10, 7:00 AM PT | Abstract # TPS268

Presenter: Anwaar Saeed, M.D.

NSABP FC-13 (EMPIRE): A phase II platform study of cemiplimab monotherapy or cemiplimab-based combinations in patients with colorectal cancer and minimal residual disease (MRD) after definitive therapy

January 10, 7:00 AM PT | Abstract # 138

Presenter: Jun Watanabe, M.D., Ph.D.

Post-hoc central radiological review of the ALTAIR study in patients with molecular residual disease (MRD) following curative resection of colorectal cancer (CRC)

January 10, 7:00 AM PT | Abstract # TPS245

Presenter: Sarah Sawyer, Ph.D.

Design of a hybrid site and decentralized clinical research study of an early detection blood test for colorectal cancer

January 10, 7:00 AM PT | Abstract # 217

Presenter: Yoshiaki Nakamura, M.D., Ph.D.

Quantification of circulating tumor DNA (ctDNA) using a methylation-based, tissue-free colorectal cancer (CRC) test for the detection of molecular residual disease (MRD)

January 10, 11:30 AM PT | Abstract # 12 (Oral Presentation)

Presenter: Hideaki Bando, M.D., Ph.D.

Impact of postoperative ctDNA dynamics on eligibility for the ALTAIR randomized trial in patients with colorectal cancer: Implications for clinical trial enrollment

About Natera

Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]