Natera to Present New Signatera™ Data Showing 10X Survival Advantage in Colorectal Cancer at ESMO

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, is set to unveil new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2024 European Society for Medical Oncology (ESMO) Congress. The event will occur from September 13-16 in Barcelona, Spain. Natera, along with its collaborators, will showcase nine abstracts in total, including five poster presentations from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the most extensive and comprehensive prospective studies focusing on MRD testing in resectable colorectal cancer (CRC).

The updated GALAXY data analyzes over 2,100 patients with stage I-IV CRC, offering 36-month disease-free survival (DFS) and, for the first time, overall survival (OS) statistics. Key findings include the observation that Signatera-positive patients have significantly shorter OS compared to Signatera-negative patients, with a hazard ratio of approximately 10. This suggests that Signatera-negative patients had an almost 10-fold advantage in OS compared to Signatera-positive patients. These findings are favorable when compared to all known guideline-recommended biomarkers, which typically have hazard ratios for overall survival in the 1-4 range.

Additionally, overall survival stratified by adjuvant chemotherapy (ACT) will be presented. This builds upon prior GALAXY DFS data, which indicated a significant benefit of ACT in Signatera-positive patients but not in Signatera-negative patients. Current standards of care suggest that most CRC patients derive a minimal absolute and relative OS benefit from ACT. Identifying subgroups where this benefit is concentrated is crucial for advancing early-stage CRC clinical management.

Minetta Liu, MD, chief medical officer of oncology at Natera, emphasized the significance of the data: "ESMO 2024 will showcase some of our most impactful data in colorectal cancer to date. 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 to predict long-term outcomes."

Other presentations at ESMO will highlight new Signatera data in breast cancer and squamous cell carcinoma of the head and neck. The full list of presentations includes:

1. Poster Presentation #553P on CRC, presented by Dr. Jun Nagata.
2. Poster Presentation #558P on CRC, presented by Dr. Kozo Kataoka.
3. Oral Presentation on CRC by Dr. Myriam Chalabi.
4. Poster Presentation #923P on squamous cell carcinoma of the head and neck (SCCHN) by Dr. Natasha Honoré.
5. Poster Presentation #555P on CRC, presented by Dr. Tomoya Harima.
6. Poster Presentation #554P on CRC, presented by Dr. Yoshiaki Nakamura.
7. Poster Presentation #545P on CRC, presented by Dr. Chiara M. Loeffler.
8. Poster Presentation #338TiP on breast cancer, presented by Dr. Michail Ignatiadis.
9. Poster Presentation #314P on breast cancer, presented by Dr. Mark Magbanua.

Signatera is designed to detect and quantify residual cancer in the body using circulating tumor DNA. It aids in identifying recurrence earlier than standard care tools and helps optimize treatment decisions. Signatera is clinically validated across multiple cancer types and is available for clinical and research use. Medicare covers the test for colorectal cancer, breast cancer, ovarian cancer, muscle-invasive bladder cancer, and for immunotherapy monitoring in any solid tumor. Published evidence in over 70 peer-reviewed papers supports its efficacy.

Natera, Inc. is a global leader in cell-free DNA and genetic testing, focusing on oncology, women's health, and organ health. The company strives to incorporate personalized genetic testing and diagnostics into standard medical care to enhance health and enable earlier, more targeted interventions. Natera operates ISO 13485-certified and CAP-accredited laboratories in Austin, Texas, and San Carlos, California.