Natera to Present New Signatera™ Clinical Data Across Multiple Cancer Types at the 2022 ASCO Annual Meeting

• NSCLC: ctDNA data in stage I-III patients showed 82% detection pre-treatment and was able to identify 100% of relapses prior to radiographic imaging (5.4 mo lead time) 
• Breast Cancer: Data from the largest longitudinal ctDNA cohort to date (>1100 samples) showed Signatera's ability to detect recurrence with high accuracy across all subtypes
• Renal Cell: ctDNA dynamics were predictive of treatment outcome in metastatic RCC patients receiving targeted therapy (TKI), after just 6 weeks
• Merkel Cell: First data showing the ability of Signatera as a surveillance tool in MCC patients regardless of MCPyV status

AUSTIN, Texas, May 31, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be presented at the 2022 ASCO^® Annual Meeting taking place June 3 – 7, 2022.

There will be seven poster presentations and one oral presentation highlighting the prognostic and predictive value of its personalized MRD technology in a wide range of tumors. These data further support Signatera as an effective tool for MRD detection and treatment response monitoring.

"These data reinforce the significant potential of ctDNA monitoring to improve outcomes for patients with breast cancer and other solid tumors," said Charles Coombes, M.D., professor of medical oncology at the Imperial College London and principal investigator of the EBLIS study.

Below are highlights of selected Signatera abstracts, with updated data to be presented at the conference:

Abstract ID: 562 | June 6, 2022, 8:00 AM-11:00 AM CDT
Serial postoperative ctDNA monitoring of breast cancer recurrence

188 patients with primary breast cancer of different molecular subtypes were followed post-surgery and adjuvant therapy for up to 12 years as part of the prospective, multi-center  EBLIS study. Serial Signatera testing predicted metastatic relapse with a median lead interval of 10 months (range: 0-39 months) and relapse detection of 88% (30/34 patients). Relapse-free and overall survival was significantly poorer in patients who were Signatera positive, regardless of subtype (HR 52.98 and 53.69, respectively).

Abstract ID: 8540 | June 6, 2022, 8:00 AM-11:00 AM CDT 
Minimal residual disease detection by ctDNA predicts and precedes radiographic disease progression in stage I-III non-small cell lung cancer patients (NSCLC) treated with definitive radiation therapy

In this prospective cohort, 17 patients with non-resectable stage I-III NSCLC were monitored before, during and after radiotherapy with or without concurrent systemic therapy and adjuvant durvalumab, for a median of 26 months. ctDNA was detected in 82% (14/17) of patients pre-treatment. 100% (9/9) of cases where clinical recurrence occurred had detectable ctDNA, a median of 5.4 months ahead of radiological relapse. ctDNA status after radiotherapy (single time point) as well as during systemic therapy (longitudinally) was highly predictive of disease recurrence (p=0.007, p<0.0001 respectively).

Abstract ID: 4525 | June 4, 2022, 1:15 PM-4:15 PM CDT 
Monitoring Efficacy of Neoadjuvant Sunitinib in Metastatic Renal Cell Carcinoma Using a Personalized and Tumor Informed ctDNA Assay

A 21-patient mRCC cohort was monitored using Signatera before and after the first cycle of sunitinib. ctDNA was detected in 81% (17/21) of patients pre-treatment. Patients whose ctDNA concentrations increased over the course of treatment were significantly more likely to experience disease progression (HR 4.9) compared to those with ctDNA decrease. In addition, ctDNA dynamics during systemic therapy allowed for detection of disease progression a median of 12 months ahead of radiographic imaging.

Abstract ID: 9566 | June 6, 2022, 1:15 PM-4:15 PM CDT 
Circulating tumor DNA to measure Merkel cell carcinoma tumor burden and detect early recurrence

In this prospective, multicenter study of 125 MCC patients, Signatera detected 100% of all clinically evident MCC cases, and primary tumor diameter was strongly correlated with ctDNA concentration (r=0.81, p<0.001). The estimated risk of recurrence was 57%, within 60 days of a positive Signatera result. In contrast, the risk of recurrence was 0% within 60 days, and 3% between 60 - 90 days, of a negative result, demonstrating the value of Signatera for MCC surveillance.

Abstract ID: 11547 | June 5, 2022, 8:00 AM-11:00 AM CDT
Circulating Tumor DNA (ctDNA) Detection of Molecular Residual Disease (MRD) as a Potential Biomarker in Localized Soft Tissue Sarcoma (STS)

Ten patients with localized, high-risk STS of different types were monitored longitudinally using Signatera at diagnosis, post surgery and radiotherapy. ctDNA was detected in 70% (7/10) of patients at diagnosis, demonstrating the feasibility of Signatera testing in this heterogeneous group of tumors.

Abstract ID: 2510 | June 6, 2022, 1:15 PM- 2:45 PM CDT 
External validation of the VIGex gene-expression signature (GES) as a novel predictive biomarker for immune checkpoint treatment (ICT).

This study investigates the predictive ability of a tissue RNA-based classifier called VIGex, in combination with ctDNA dynamics using Signatera, in patients treated with pembrolizumab in the INSPIRE trial. A total of 57 patients had both VIGex and ctDNA data. VIGex was predictive of treatment response, independently of PD-L1 and TMB, with predictive performance further improved by the addition of on-treatment ctDNA dynamics.

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 assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

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 100 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. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., [email protected]

SOURCE Natera, Inc.