Natera, Inc. has announced the publication of three peer-reviewed papers highlighting the clinical utility of its Signatera molecular residual disease (MRD) test in colorectal cancer (CRC) and triple-negative breast cancer (TNBC). The publications, featured in Nature Medicine and Annals of Oncology, underscore Signatera's potential to predict treatment response and optimize patient management.
Colorectal Cancer: Predicting Overall Survival and Adjuvant Chemotherapy Benefit
The first study, published in Nature Medicine, analyzed data from 2,240 patients with stage II-IV CRC who were monitored using Signatera after curative-intent surgery. With a median follow-up of 23 months, the data demonstrated that Signatera-based MRD detection can predict overall survival (OS) and identify patients who would benefit from adjuvant chemotherapy (ACT).
Another study, published in Annals of Oncology, retrospectively analyzed 190 patients from the GALAXY trial who underwent surgical resection for colorectal liver metastases. The results indicated that Signatera can effectively risk-stratify CRC patients. Specifically, patients who were Signatera-positive within 2-10 weeks after surgery showed superior 24-month disease-free survival (DFS) with ACT compared to observation. In contrast, Signatera-negative patients did not experience a statistically significant benefit from ACT.
Triple-Negative Breast Cancer: Identifying Responders to Immunotherapy
The third paper, also published in Nature Medicine, presented initial results from the BELLINI trial, a phase 2 study involving 43 patients with stage I-III TNBC. Patients received short-term nivolumab, either alone or with ipilimumab, before standard neoadjuvant chemotherapy or surgery. Circulating tumor DNA (ctDNA) analysis using Signatera was performed before treatment and after 4-6 weeks. The study found that all clinical responders, including those achieving pathologic complete response, exhibited at least a 50% decrease in ctDNA levels or were ctDNA-negative at baseline.
Expert Commentary
"We are extremely proud to announce the publication of these datasets in top-tier medical journals, underscoring the breadth of clinical evidence we continue to build on the utility of Signatera," said Alexey Aleshin, MD, MBA, general manager of oncology and chief medical officer of Natera. "The first overall survival readout in colorectal cancer from GALAXY marks a landmark moment that may fundamentally change how resectable colorectal cancer is managed for the hundreds of thousands of patients at risk of recurrence each year."
Signatera's Role in Personalized Cancer Management
Signatera is a personalized, tumor-informed MRD test designed for patients with a prior cancer diagnosis. By analyzing circulating tumor DNA, Signatera can detect and quantify residual cancer, identify recurrence earlier, and guide treatment decisions. The test is available for clinical and research use and is covered by Medicare for several cancer types, including CRC, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor.
