Natera Announces New MRD Data in Multiple Tumor Types, to be Presented at ASCO Annual Meeting

Rhea-AI Summary

Natera (NASDAQ: NTRA) will present new data at the 2024 ASCO Annual Meeting, May 31 – June 4, 2024. The data spans multiple cancer types, including breast, colorectal (CRC), lung, melanoma, esophageal, and urothelial cancers. Natera's Signatera™ and Empower™ tests will be highlighted in one oral and 13 poster presentations. Key studies include the CIRCULATE-Japan GALAXY study, showcasing the prognostic and predictive utility of Signatera for CRC. Natera expects topline results from the ALTAIR phase III trial by August 2024. Presentations will demonstrate ctDNA's role in detecting minimal residual disease and monitoring treatment responses in various cancers.

Positive

• Natera will present new data across multiple cancer types at the 2024 ASCO Annual Meeting, highlighting the broad application of its technologies.
• The CIRCULATE-Japan GALAXY study showed promising results for Signatera in colorectal cancer, enhancing its clinical credibility.
• Natera expects to announce phase III results for the ALTAIR trial in August 2024, providing a timeline for potentially impactful data.
• Natera’s presentations will cover significant real-world studies and randomized trials, indicating robust clinical validation.

Negative

• The outcomes of the ALTAIR trial, expected in August 2024, could introduce uncertainty until the results are known.
• Focus on multiple tumor types may dilute investor focus on core areas of strength.

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that the company, along with its collaborators, will present new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024.

The presentations feature data across a variety of indications, including breast cancer, colorectal cancer (CRC), lung cancer, melanoma, esophageal cancer, and urothelial cancer, with one oral presentation and 12 poster presentations on Signatera™, Natera’s personalized and tumor-informed molecular residual disease test, as well as one poster with data on Empower™, Natera’s test for hereditary cancer.

Minetta Liu, MD, chief medical officer of oncology at Natera, said, “We look forward to sharing new data across cancer types, reflecting Natera's deep clinical pipeline in MRD with results from randomized trials as well as real-world studies. This includes promising new findings from the CIRCULATE-Japan GALAXY study demonstrating the prognostic and predictive utility of Signatera and actionable biomarkers in colorectal cancer.”

GALAXY is part of the CIRCULATE-Japan trial platform, which also includes ALTAIR, a first-of-its-kind, “treat on molecular recurrence” study evaluating the utility of Signatera in CRC. Natera expects to announce topline results for this phase III randomized trial in August 2024.

Below is the full list of presentations featuring Signatera and Empower at ASCO:

• Poster Presentation | Abstract # 3609 | Presenter: Yoshiaki Nakamura, MD, PhD | CRC
  Prognostic and predictive value of ctDNA-based MRD and actionable biomarkers in patients with resectable CRC: CIRCULATE-Japan GALAXY

• Oral Presentation | Abstract # LBA507 | Presenter: Sherene Loi, MD, PhD | Breast Cancer
  Prognostic utility of ctDNA dynamics in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC)

• Poster Presentation | Abstract # 3586 | Presenter: Eric Lander, MD | CRC
  Genomic alterations in early-onset versus average-onset stage IV CRC

• Poster Presentation | Abstract # 5034 | Presenter: Rebecca Hassoun, MD | Testicular Cancer
  Longitudinal Evaluation of ctDNA as a Prognostic Biomarker to Detect Minimal Residual Disease (MRD) in Testicular Cancer

• Poster Presentation | Abstract # 4587 | Presenter: Adanma Ayanambakkam, MD | Urothelial Cancer
  Longitudinal analysis of ctDNA in localised and metastatic urothelial cancer

• Poster Presentation | Abstract # 4028 | Presenter: Aziz Zaanan, MD | Esophageal Cancer
  Longitudinal ctDNA analysis during treatment (Tx) of locally advanced resectable (LAR) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ADENOCA): the PLAGAST prospective biomarker study

• Poster Presentation | Abstract # 9564 | Presenter: Michael LaPelusa, MD | Melanoma
  Association between ctDNA and Recurrence-Free Survival (RFS) in Patients (pts) with Resected Stage III Melanoma - an Exploratory Analysis of SWOG S1404

• Poster Presentation | Abstract # 6056 | Presenter: Glenn Hanna, MD | Head and Neck Squamous Cell Carcinoma
  Personalized ctDNA for monitoring disease status in HPV-negative head and neck squamous cell carcinoma

• Poster Presentation | Abstract # TPS8659 | Presenter: Yasushi Goto, MD, PhD | Lung Cancer
  Randomized phase III study comparing suspension or continuation of PD- 1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study: JCOG1701)

• Poster Presentation | Abstract # 569 | Presenter: Mridula George, MD | Breast Cancer
  Predicting response to neoadjuvant therapy (NAT) in patients (pts) with early-stage breast cancer (BC) using ctDNA testing

• Poster Presentation | Abstract # 549 | Presenter: Marla Lipsyc-Sharf, MD | Breast Cancer
  Impact of ctDNA surveillance on clinical care for patients with stage I-III breast cancer: Findings from a multi-institutional study.

• Poster Presentation | Abstract # 518 | Presenter: Yoichi Naito, MD | Breast Cancer
  ctDNA monitoring for breast cancer at high risk of recurrence: Interim analysis of JCOG1204A1

• Poster Presentation | Abstract # 10596 | Presenter: Sarah Lee, MD | Pan-Cancer (Empower)
  A targeted panel of actionable high risk hereditary cancer predisposition genes can identify patients with pathogenic/likely pathogenic variants (PVs) irrespective of meeting established NCCN testing criteria

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, ovarian cancer 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 60 peer-reviewed papers.

About Natera

Natera™ is a global leader in cell-free DNA and genetic 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 supported by more than 200 peer-reviewed publications that demonstrate excellent performance. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240523550998/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

FAQ

What new data will Natera present at the 2024 ASCO Annual Meeting?

Natera will present data on its Signatera™ and Empower™ tests across various cancers, including breast, colorectal, lung, melanoma, esophageal, and urothelial.

What is the significance of the CIRCULATE-Japan GALAXY study for Natera?

The CIRCULATE-Japan GALAXY study demonstrates the prognostic and predictive utility of Signatera in colorectal cancer, which could enhance its clinical use.

When will Natera announce the results of the ALTAIR phase III trial?

Natera expects to announce topline results for the ALTAIR phase III trial in August 2024.

What types of cancer are included in Natera's presentations at ASCO?

Natera's presentations will include data on breast, colorectal, lung, melanoma, esophageal, and urothelial cancers.

How many presentations will Natera have at the 2024 ASCO Annual Meeting?

Natera will have one oral presentation and 13 poster presentations at the 2024 ASCO Annual Meeting.