On September 8, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place Sept. 13-16 in Barcelona, Spain (Press release, Natera, SEP 8, 2024, View Source [SID1234646417]).
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Natera and its collaborators will present a total of nine abstracts, including five poster presentations from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC).
The GALAXY data includes an updated analysis of more than 2,100 patients with stage I-IV CRC, reporting 36-month disease-free survival (DFS), and, for the first time, overall survival (OS). Key highlights include:
Signatera-positive patients had significantly shorter OS compared to those who were Signatera-negative (hazard ratio of ~10), suggesting that Signatera-negative patients had an almost 10-fold advantage in OS. This compares favorably to all known guideline recommended biomarkers that typically have hazard ratios for overall survival in the 1-4 range.
Overall survival stratified by adjuvant chemotherapy (ACT) will also be presented. This will build on prior GALAXY DFS data which has shown significant benefit of ACT in Signatera-positive patients, but 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.
"ESMO 2024 will showcase some of our most impactful data in colorectal cancer 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 to predict long-term outcomes."
Other presentations at ESMO (Free ESMO Whitepaper) will highlight new Signatera data in breast cancer and squamous cell carcinoma of the head and neck. Below is the full list of presentations:
Presentation Highlights
Poster Presentation #553P | CRC | Sept. 16 | Presenter: Jun Nagata, MD
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 | CRC | Sept. 16 | Presenter: Kozo Kataoka, MD, PhD
Survival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases; subgroup analysis from CIRCULATE-Japan GALAXY
Oral Presentation and Additional Presentations
Oral Presentation | CRC | Presenter: Myriam Chalabi, MD
Sept. 15, 09:10 – 09:20
Neoadjuvant immunotherapy in locally advanced MMR-deficient (dMMR) colon cancer (CC): 3-year disease-free survival (DFS) from NICHE-2
Poster Presentation #923P | SCCHN | Sept. 14 | Presenter: Natasha Honoré, MD, PhD
Tumor-informed ctDNA assay to predict recurrence in locally advanced SCCHN
Poster Presentation #555P | CRC | Sept. 16 | Presenter: Tomoya Harima, MD
Association Between Copy Number Aberration and ctDNA MRD in Colorectal Cancer: CIRCULATE-Japan GALAXY
Poster Presentation #554P | CRC | Sept. 16 | Presenter: Yoshiaki Nakamura, MD, PhD
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 | CRC | Sept. 16 | Presenter: Chiara M. Loeffler, MD
HIBRID: Histology and ct-DNA based Risk-stratification with Deep Learning
Poster Presentation #338TiP | Breast Cancer | Sept. 16 | Presenter: Michail Ignatiadis, MD, PhD
EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)
Poster Presentation #314P | Breast Cancer | Sept. 16 | Presenter: Mark Magbanua, PhD
The impact of changes in tumor mutational landscape during neoadjuvant therapy on tumor-informed ctDNA testing in breast cancer patients
About Signatera
Signatera 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, breast cancer, 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.