Natera's Signatera Shows 10-Fold Overall Survival Advantage in Colorectal Cancer
核心洞察
Natera will present new data on Signatera (搜索), its MRD test, at the ESMO Congress, including findings from the CIRCULATE-Japan GALAXY trial.
Signatera (搜索)-positive patients in the GALAXY trial had a significantly shorter overall survival compared to Signatera-negative patients, with a hazard ratio of approximately 10.
Updated analysis from the GALAXY arm of CIRCULATE-Japan includes the first prospective read-out of overall survival based on MRD in over 2,100 patients.
Natera, Inc. will present new data on its Signatera (搜索) molecular residual disease (MRD) test at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain. The presentations include abstracts from the GALAXY arm of the CIRCULATE-Japan trial, along with new data in breast cancer (搜索) and squamous cell carcinoma (搜索) of the head and neck.
Signatera's Impact on Overall Survival in Colorectal Cancer
The GALAXY data includes an updated analysis of over 2,100 patients with stage I-IV colorectal cancer (搜索) (CRC), reporting 36-month disease-free survival (DFS) and, for the first time, overall survival (OS). Key findings indicate that Signatera (搜索)-positive patients had a significantly shorter OS compared to those who were Signatera-negative, with a hazard ratio of approximately 10. This suggests that Signatera-negative patients had an almost 10-fold advantage in OS, which compares favorably to guideline-recommended biomarkers that typically have hazard ratios for overall survival in the 1-4 range.
Adjuvant Chemotherapy Stratification
Overall survival stratified by adjuvant chemotherapy (ACT) will also be presented. This analysis builds on prior GALAXY DFS data, which has shown a significant benefit of ACT in Signatera (搜索)-positive patients but a lack of benefit in Signatera-negative patients. The current standard of care is based on studies showing that most CRC patients derive a small ~0-5% absolute and ~10-20% relative OS benefit from ACT. Identifying subgroups where this benefit is concentrated is critical for advancing clinical management of early-stage CRC.
Expert Commentary
"ESMO 2024 will showcase some of our most impactful data in colorectal cancer (搜索) to-date," said Minetta Liu, MD, chief medical officer of oncology at Natera. "Notably, we will present an updated analysis from the GALAXY arm of CIRCULATE-Japan with the first prospective read-out of overall survival based on MRD. These findings underscore the potential for Signatera (搜索) to predict long-term outcomes."
Additional Presentations
Other presentations at ESMO will highlight new Signatera (搜索) data in breast cancer (搜索) and squamous cell carcinoma (搜索) of the head and neck. The presentations include:
- Poster Presentation #553P: Association of ctDNA-based MRD detection and MRD clearance with short-term overall survival in patients with resectable colorectal cancer: Updated analysis of CIRCULATE-Japan GALAXY
- Poster Presentation #558P: Survival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases; subgroup analysis from CIRCULATE-Japan GALAXY
- Oral Presentation: Neoadjuvant immunotherapy in locally advanced MMR-deficient (dMMR) colon cancer (CC): 3-year disease-free survival (DFS) from NICHE-2
- Poster Presentation #923P: Tumor-informed ctDNA assay to predict recurrence in locally advanced SCCHN
- Poster Presentation #555P: Association Between Copy Number Aberration and ctDNA MRD in Colorectal Cancer: CIRCULATE-Japan GALAXY
- Poster Presentation #554P: Novel Clinical Decision Support (CDS) System Optimizing Adjuvant Chemotherapy (ACT) for Colorectal Cancer (CRC) by Integrating Deep Learning and circulating tumor DNA (ctDNA) molecular residual disease (MRD): GALAXY Histotyping
- Poster Presentation #545P: HIBRID: Histology and ct-DNA based Risk-stratification with Deep Learning
- Poster Presentation #338TiP: EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)
- Poster Presentation #314P: The impact of changes in tumor mutational landscape during neoadjuvant therapy on tumor-informed ctDNA testing in breast cancer patients
About Signatera
Signatera (搜索) is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer (搜索), breast cancer (搜索), ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 70 peer-reviewed papers.