On September 17, 2021 Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, reported new data being presented by the company and its collaborators on the use of the Signatera personalized molecular residual disease (MRD) technology at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 16–21, 2021 (Press release, Natera, SEP 17, 2021, View Source [SID1234587911]).
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In three new studies, Natera will present the real-world clinical performance of Signatera in esophageal and gastric cancers, the power of ctDNA dynamics for assessing treatment response in uveal melanoma and the correlation of CHIP mutations with patient outcomes.
"Results from our study indicate that ctDNA is highly predictive of relapse in patients with gastroesophageal cancer," said Brandon Huffman, M.D., clinical oncology fellow at Dana Farber Cancer Institute and Massachusetts General Hospital Cancer Center, and first author of the study. "Most gastroesophageal cancers recur after definitive treatment, and patients with advanced disease have a poor overall prognosis. This study addresses a huge need for tools to better identify patients at risk of recurrence and to inform disease management."
"This data underscores the value of tumor-informed MRD assessment in GI cancers," said Alexey Aleshin, M.D., Natera’s VP of medical affairs, oncology. "It also highlights the potential for Signatera to improve upon radiographic imaging as a clinical endpoint, which can accelerate drug development and improve patient care."
Details about the presentations are as follows:
Performance of a tumor-informed circulating tumor DNA assay from over 260 patients with over 800 plasma time points in esophageal and gastric cancer
On-Demand ePoster: 1415P
Presenter: Griffin L. Budde, Natera, Inc.
This study used Signatera for the detection and quantification of ctDNA in a prospective real-world cohort of 886 plasma samples from 269 patients with gastroesophageal cancer. Serial time points were collected in a subset of patients to monitor ctDNA levels after curative intent therapy. Analysis showed tumor-informed ctDNA status is highly predictive of relapse in patients with stage I-IV disease, with ctDNA detected in 93.3% of samples at baseline.
Early reduction in ctDNA, regardless of best RECIST response, is associated with overall survival (OS) on tebentafusp in previously treated metastatic uveal melanoma (mUM) patients
Mini Oral Presentation: 1757O
Presenter: Alexander Shoushtari, M.D.
Date: Sunday, September 19, 2021, 13:40 CEST
Uveal melanoma is a rare type of melanoma of the eye, associated with frequent liver metastases. This study of 127 mUM patients used a custom ctDNA assay for the evaluation of tebentasfusp therapy. Baseline ctDNA levels significantly correlated with tumor burden, and by week 9, 70% of evaluable patients showed ctDNA reduction associated with greater mean tumor shrinkage. For tebentafusp, ctDNA reduction appeared more correlated with overall survival than RECIST response.
Association of clonal hematopoiesis of indeterminate potential with higher risk of disease progression
On-Demand ePoster: 1762P
Presenter: Derek Klarin, M.D.
Buffy coat samples derived from 2484 patients diagnosed with colorectal, breast, lung and other solid cancers were analyzed for the presence of CHIP mutations, which were detected in 16% of patients, with the majority having a single mutation. As expected, the frequency of CHIP increased with age and reached 20% in patients above 60 years, who were also more likely to have multiple CHIP variants compared to the younger patients. Although CHIP mutations are not tumor-derived and should not be used to monitor MRD burden, the presence of CHIP in MRD-positive cases was associated with poor patient outcomes and reduced time to recurrence.
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.
Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.