AUSTIN, Texas — Natera, Inc., a global leader in cell-free DNA testing, presented new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the American Society of Clinical Oncology’s 2024 Gastrointestinal Cancers Symposium (ASCO GI), that took place January 18 – 20, 2024 in San Francisco, California.
Natera and its collaborators presented 11 abstracts that feature new Signatera data across various GI indications, including two oral presentations. An updated analysis from the previously published GALAXY study, the observational arm of the prospective CIRCULATE-Japan trial, was presented in an oral presentation at the symposium and was also featured in ASCO GI’s press program. GALAXY is one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC).
Additionally, the first read-out from the Natera-sponsored BESPOKE CRC study was presented in a rapid oral presentation. BESPOKE CRC is the first large, prospective, US-based study in resectable CRC, with over 130 participating sites.
Highlights from the abstracts selected for oral presentation included:
Abstract ID: 6 | Oral Abstract Session C | CRC | Presenter: Hiroki Yukami, MD
Circulating tumor DNA (ctDNA) dynamics in CRC patients (pts) with MRD: Updated analysis from GALAXY study in CIRCULATE-JAPAN
This latest analysis from GALAXY included close to 3,000 stage I-IV CRC patients. Key findings include:
- ctDNA dynamics at the six-month time point post-surgery showed that patients who remained ctDNA-positive were >6 times more likely to recur compared to those who cleared their ctDNA.
- ctDNA-positive patients with sustained clearance in subsequent time points as a result of adjuvant chemotherapy (ACT) had remarkably better outcomes compared to those with transient ctDNA clearance (24-month DFS rate; 90.1% vs 2.3%) or no clearance (24-month DFS rate; 90.1% vs 2%).
- In ctDNA-positive patients treated with ACT, a >50% decrease in ctDNA MTM/mL levels at six months, including those with complete clearances, was associated with better DFS than a <50% decrease or increase (24-month DFS rate; 51.1% vs 29%).
Abstract ID: 9 | Rapid Oral Abstract Session C | CRC | Presenter: Pashtoon Kasi, MD, MS
ctDNA for informing adjuvant chemotherapy (ACT) in stage II/III CRC: Interim analysis of BESPOKE CRC study
This analysis included 689 patients with stage II/III resectable CRC. Key findings include:
- Within the ctDNA-positive cohort, patients receiving ACT had significantly longer DFS compared to those in the observation group (24-month DFS rate; 42.4% vs 12.5%). No benefit of ACT was observed in ctDNA-negative patients.
- ctDNA monitoring allowed for oligometastases-directed therapy in 40% of patients who recurred.
- A separate poster on the BESPOKE CRC study (abstract ID: 54) found that in 400+ patients surveyed, ≥92% valued the information received from their Signatera results or would use Signatera to guide their clinical care. In addition, 73% reported that Signatera results reduced anxiety about cancer recurrence.
“These latest findings from the landmark CIRCULATE trial underscore Signatera’s ability to identify patients who may be more likely to benefit from adjuvant chemotherapy, showing the value of personalized MRD testing to guide treatment decisions in CRC and potentially spare patients from unnecessary toxicity,” said Hiroki Yukami, MD, from the Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, and lead study author of the GALAXY study. “We are encouraged by the widespread attention and recognition this presentation has received from the oncology community, and are optimistic that the GALAXY study, along with the ALTAIR escalation and VEGA de-escalation arms of CIRCULATE, will fundamentally change the way CRC is treated.”
“We are pleased to share new data from the Japanese-based GALAXY and US-based BESPOKE CRC studies, which further demonstrate the prognostic and predictive power of longitudinal testing with Signatera in resectable colorectal cancer,” said Minetta C. Liu, MD, chief medical officer of oncology at Natera. “These two prospective clinical trials provide strong evidence supporting the clinical utility of Signatera to inform adjuvant chemotherapy decisions and facilitate surveillance for cancer recurrence.”
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 (stage IIb and higher) 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 50 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California.
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