Highlights include oral presentations in Sarcoma and CRC; immunotherapy monitoring data from the Phase 3 EMPOWER-Lung 1 study; updates from the CIRCULATE-Japan study in CRC

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 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2 – 6, 2023. Signatera and Natera’s circulating tumor DNA (ctDNA) technology will be featured across a wide variety of cancers, including colorectal (CRC), lung, bladder, esophageal, pancreatic, melanoma, sarcoma and cholangiocarcinoma.

“We are grateful for the opportunity to share new data at ASCO that furthers Natera’s leadership in the ctDNA space,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “These presentations provide additional support for the role of ctDNA in predicting patient outcomes and assessing treatment response in both common and rare cancers. Use of data generated from our ctDNA technology to broaden our understanding of tumor biology is also demonstrated. We are thrilled to collaborate with the oncology community in pursuit of better outcomes for patients living with cancer.”

Highlights from selected abstracts include:

Abstract #9022 | NSCLC | Poster Discussion

ctDNA dynamics and survival outcomes in patients with advanced non-small cell lung cancer and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab vs chemotherapy

Results will be presented from the Phase 3 EMPOWER-Lung 1 study of 175 NSCLC patients randomized to chemotherapy vs cemiplimab. In patients treated with cemiplimab, ctDNA increase was associated with the highest risk of death, while clearance and a >90% decrease in ctDNA were associated with significantly improved overall survival.

Abstract #3521 | CRC | Poster Discussion

ctDNA dynamics as an early predictor of recurrence in patients with radically resected CRC: Updated results from GALAXY study in the CIRCULATE-Japan

Expanded analysis with 2,083 stage II-IV patients shows a strong hazard ratio at 4 weeks post surgery (HR 12.0; p<0.001), compared to the interim update published in early 2021 by Kotani, et al (HR 10.0; p<0.0001). Also, in patients with ctDNA negativity at 4 weeks, no significant difference in DFS was observed between BRAF V600E mutant and wild-type groups (p=0.306).

Abstract #3522 | CRC | Poster Discussion

Positive ctDNA-based Minimal Residual Disease Assays During Surveillance Are Associated with High Rates of Undiagnosed Concomitant Radiographic Recurrences in CRC - Results from the MD Anderson INTERCEPT Program

Of 1,115 CRC patients included in this analysis from the INTERCEPT program, 49% (90/184) of patients who were ctDNA-positive during surveillance were found to have recurrent disease with reflex imaging. Of the patients who were ctDNA-positive during surveillance, but without radiologic evidence of disease, 59% (55/94) were enrolled into ongoing MRD-focused clinical trials.

Below are the additional ASCO presentations that highlight ctDNA data from Signatera and Natera’s collaborators:

• Abstract #11509 | Sarcoma | Oral Presentation
  
  MRD detection using bespoke ctDNA assays in localized Soft Tissue Sarcoma (STS)

• Abstract #3511 | CRC | Oral Presentation
  
  Evaluation of genomic alterations in over 13000 patients with early-onset versus late-onset CRC

• Abstract #3050 | MIBC | Poster Presentation
  
  Association of Tumor-Informed MRD with Clinical Outcomes for Muscle Invasive Bladder Cancer (MIBC) – A Multicenter Retrospective Real World Analysis

• Abstract #3041 | Esophageal Cancer | Poster Presentation
  
  Longitudinal ctDNA monitoring in patients with esophageal squamous cell carcinoma

• Abstract #9582 | Melanoma | Poster Presentation
  
  Longitudinal ctDNA monitoring for detection of molecular residual disease in patients with surgically resected stage II/III melanoma

• Abstract #9075* | NSCLC | Poster Presentation
  
  ctDNA Monitoring Informs Maintenance Outcomes in Patients (pts) with Advanced NSCLC Treated with Induction Atezolizumab+Carboplatin+Nab-Paclitaxel (A+CnP)

• Abstract #4066 | Esophageal Cancer | Poster Presentation
  
  ctDNA as a marker of recurrence risk in locoregional esophagogastric cancers with pathologic complete response

• Abstract #4123 | Bile Duct Cancer | Poster Presentation
  
  Utility of ctDNA as a predictive biomarker for disease monitoring in patients with cholangiocarcinoma (CCA) before and during adjuvant chemotherapy: sub-analysis of the randomized phase 2 STAMP trial

• Abstract #4053 | Pancreatic Cancer | Poster Presentation
  
  ctDNA and Association with CAR-T Cell Therapy Response in Gastric and Pancreatic Cancer Patient

• Abstract #8598 | Thymus Cancer | Poster Presentation
  
  Utilization of ctDNA analysis to detect minimal residual disease post-surgery and disease progression in metastatic thymic tumors

All abstracts can be found on the ASCO website here.

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. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, 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.

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*Abstract #9075 uses ctDNA monitoring with FoundationOne®Tracker.

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