Natera Announces Three New Signatera Publications; Includes Groundbreaking Overall Survival Data Published in Nature Medicine and also Released at ESMO

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the simultaneous publication of three peer-reviewed papers, crossing a milestone of more than 85 peer-reviewed publications on Signatera. This includes:

• Groundbreaking colorectal cancer (CRC) data from the GALAXY arm of the ongoing CIRCULATE-Japan trial, published today in Nature Medicine, and also available in Poster Presentation #553P at the 2024 Congress of the European Society for Medical Oncology (ESMO) in Barcelona, Spain.
• Additional CRC data from GALAXY, published today in Annals of Oncology, and also available in Poster Presentation #558P at ESMO.
• A new paper from the BELLINI trial, published today in Nature Medicine, investigating the feasibility and potential efficacy of immune checkpoint inhibitors (ICI) without concurrent chemotherapy in triple negative breast cancer (TNBC).

CRC Data from GALAXY (Nature Medicine & ESMO Poster)

In this study, 2,240 patients with stage II– IV CRC were monitored using Signatera after curative-intent surgery with a median follow-up of 23 months. This data provides the first evidence of Signatera-based molecular residual disease (MRD) detection to predict overall survival (OS) and highlights Signatera’s ability to predict adjuvant chemotherapy (ACT) benefit. Full details on the data are available here, as announced on Sept. 14, 2024.

CRC Data from GALAXY (Annals of Oncology & ESMO Poster)

This study retrospectively analyzed 190 patients enrolled in GALAXY who underwent surgical resection for colorectal liver metastases and underscores Signatera’s ability to risk-stratify CRC patients. Of the patients who were Signatera-positive within 2-10 weeks after surgical resection, 24-month disease free survival (DFS) was superior for those who received ACT compared to patients on observation, whereas no statistically significant benefit of ACT was observed among Signatera-negative patients.

Breast Cancer Data from Bellini Trial (Nature Medicine)

This study reports initial results from the BELLINI trial, a phase 2 study that enrolled 43 patients with stage I-III triple-negative breast cancer (TNBC). Patients in the study underwent short-term (2-3 cycles) of nivolumab, alone or in combination with ipilimumab, prior to standard-of-care neoadjuvant chemotherapy or surgery. Circulating tumor DNA (ctDNA) analysis with Signatera was performed before treatment and after 4 or 6 weeks of treatment. All clinical responders including patients who achieved pathologic complete response demonstrated at least a 50% decrease in ctDNA levels, or were ctDNA-negative at baseline.