NTRA News & Events

Natera announced the publication of new data in JAMA Oncology, evaluating the utility of Signatera, its personalized molecular residual disease test, in patients with resected colorectal liver metastases. The data was also presented as an oral presentation at the 2026 European Society for Medical Oncology Gastrointestinal Congress. The liver is the most common site of distant metastasis in colorectal cancer, and CRLM is a major cause of cancer-related mortality. In patients where curative-intent surgery is possible, the benefit of adjuvant chemotherapy has been a point of debate and uncertainty. MRD status has previously been shown to predict a disease free survival benefit from ACT, but not an overall survival benefit. This is the first dataset in a large cohort to show MRD test prediction of OS from ACT in this population. The JAMA paper included 298 patients from the GALAXY trial, the prospective, observational arm of CIRCULATE-Japan. Outcomes were evaluated according to MRD status and whether patients received ACT, with a median follow-up of 43 months. Key findings included: Signatera identified patients who derive a significant survival benefit from ACT. Among MRD-positive patients who underwent surgery without neoadjuvant chemotherapy, ACT was associated with improved DFS and OS compared to observation. MRD-negative patients had favorable outcomes, with no observed survival benefit from ACT. Post-surgical MRD status was strongly prognostic. MRD positivity 2-10 weeks after surgery was associated with significantly worse DFS and OS, including those who received neoadjuvant chemotherapy before surgery, and those who did not.

Natera and Aveta Biomics announced a strategic partnership supporting AVTA 30-01, Aveta's global Phase 3 registrational clinical trial evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma. APG-157 is Aveta's first-in-class oral immunotherapy intended to expand the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC. APG-157 has received FDA Fast Track and Orphan Drug Designations for this indication. AVTA 30-01 builds upon previously reported Phase 2 clinical data of APG-157 monotherapy in demonstrating favorable safety, evidence of tumor-control, deep molecular responses, and encouraging event-free survival outcomes. The trial will incorporate serial Signatera testing to assess molecular residual disease and treatment response throughout therapy and follow-up. Circulating tumor DNA has emerged as one of the most promising approaches for detecting MRD and identifying recurrence earlier than conventional imaging alone. Approximately 826 patients are expected to be enrolled across North America, Europe, Asia-Pacific, and Australia. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms, and Signatera will be a secondary endpoint. The trial is expected to begin enrollment in 2H'26.