New Signatera™ Data in Multiple Myeloma, Colorectal Cancer and Ovarian Cancer Highlights Clinical Utility of MRD in Real-World Settings

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) announced new clinical data on its molecular residual disease (MRD) assay, Signatera, to be presented at the ASCO annual meeting from June 4-8, 2021. Highlights include four presentations focusing on multiple myeloma and colorectal cancer. Notable findings from the CIRCULATE-Japan trial indicate a >94% pre-surgical detection rate for early-stage colorectal cancer using Signatera. The study emphasizes the test's non-invasive approach compared to traditional bone marrow aspirations and its potential for improved patient monitoring.

Positive

• Signatera shows >94% pre-surgical detection rate for colorectal cancer.
• Signatera provides non-invasive MRD assessment, improving patient monitoring.
• Clinical validation across multiple cancer types enhances credibility.

Negative

• None.

AUSTIN, Texas, May 26, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new clinical data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the 2021 American Society of Clinical Oncology (ASCO) annual meeting, taking place June 4-8, 2021. Two additional studies were presented at the 2021 American Association for Cancer Research (AACR) annual meeting that took place April 9-14, 2021.

At ASCO, Natera will present four posters highlighting the use of Signatera in new indications including multiple myeloma. It will also unveil new colorectal cancer data from the CIRCULATE-Japan trial, the largest prospective MRD study to date.

"We are proud to share this wealth of new data with the larger oncology community," said Alexey Aleshin, M.D., Natera's vice president of medical affairs, oncology. "The quality and quantity of these real-world data is a testament to the power of Signatera's tumor-informed and personalized technology and to Natera's commitment to pushing the boundaries of our understanding of MRD."

Details about the ASCO abstracts are as follows:

Abstract #8029 | Poster Presentation | Presenter: Binod Dhakal, M.D.

Personalized ctDNA analysis to detect minimal residual disease and identify patients at high risk of relapse with multiple myeloma

A retrospective study on the feasibility of using Signatera for MRD assessment in multiple myeloma. Archival bone marrow aspirates and formalin-fixed, paraffin-embedded (FFPE) slides from 28 patients taken at the time of diagnosis were used to design the custom MRD assay for that individual. Patients were serially monitored for a median of 92.4 months after autologous stem cell transplantation (AHCT). Despite the low quality of the samples, the MRD-positive patients had a significantly higher rate of relapse and poorer recurrence-free survival than those who had no detectable MRD after AHCT (HR 5.6, 95% CI: 1.8 - 17, p= 0.0003).

"The variability in sampling of bone marrow aspirates often provides an inaccurate estimate of marrow MRD. Further, serial monitoring of MRD status using bone aspiration is challenging due to the invasive nature of the procedure," said Dr. Binod Dhakal, associate professor of medicine, the Medical College of Wisconsin, and first author of the study. "We are encouraged by the data from this study as it shows that a sensitive ctDNA test can provide a non-invasive alternative that captures the spatial heterogeneity of multiple myeloma."

Abstract #3608 | Poster Presentation | Presenter: Hiroki Yukami, M.D.

Minimal residual disease by circulating tumor DNA analysis for colorectal cancer patients receiving radical surgery: An initial report from CIRCULATE-Japan

CIRCULATE-Japan is the largest prospective MRD study to date. Initial analysis from the first 400 early-stage (stage II-III) or relapsed colorectal cancer (CRC) patients in this observational study shows that Signatera's tumor-informed approach has a pre-surgical detection rate of >94% across stage I-III CRC patients, and a post-surgical relapse detection rate of 92% with longitudinal sampling. These detection rates compare favorably to longitudinal results from tissue-naive approaches. Additionally, the failure rate of patient samples using Signatera was very low at <3%.

Abstract #3540 | Poster Presentation | Presenter: Tenna V. Henriksen, M.S.

Serial circulating tumor DNA analysis for assessment of recurrence risk, benefit of adjuvant therapy, growth rate and early relapse detection in patients with stage III colorectal cancer

This study serially monitors 168 stage III CRC patients using Signatera for 36 months after surgery, during and after adjuvant chemotherapy, and during surveillance. It demonstrates, for the first time, that the quantitative measurement of ctDNA levels provided by Signatera can be used to assess the growth rates of metachronous metastases. Patients may be classified as having either a slow- or fast-growing tumor based on the rate of increase of ctDNA. Those with fast-growing tumors (137% increase per month) had significantly poorer overall survival compared to those with slow-growing tumors (27% increase per month), underscoring the clinical utility of ctDNA quantitation in the management of stage III CRC.

Abstract #4103 | Poster Presentation | Presenter: Pashtoon Kasi, M.D., M.S.

Tumor-informed assessment of circulating tumor DNA and its incorporation into practice for patients with hepatobiliary cancers

This exploratory study establishes the feasibility of using a tumor-informed MRD test in a heterogeneous cohort of 113 patients with hepatocellular carcinoma, cholangiocarcinoma and gallbladder cancer. Detection rates pre- and post-surgery, during treatment, and surveillance, are reported and shown to correlate with disease stage.

Details about the AACR abstracts are as follows:

Abstract #552 | Poster Presentation | Presenter: Jocelyn Chapman, M.D.

Circulating tumor DNA predicts disease recurrence in ovarian cancer patients

This study demonstrates the prognostic value of ctDNA in 70 patients with stage I-IV epithelial ovarian cancer (EOC), in comparison to blood biomarker CA-125. The presence of ctDNA was observed to be a strong predictor of relapse (p<0.0001), while CA-125 was not significantly associated with relapse-free survival (p=0.09). ctDNA detection preceded radiological relapse by a median of 10 months (p<0.05), while CA-125 had a lead time of approximately one month.

Abstract #569 | Poster Presentation | Presenter: Antony Tin, Ph.D.

Correlation of variant allele frequency and mean tumor molecules with tumor burden in patients with solid tumors

This poster compares two common measures of tumor burden in cfDNA — variant allele frequency (VAF) and mean tumor molecules (MTM) per mL of plasma. 13,218 plasma samples from 6,265 patients with a wide range of cancer types were analyzed, and discordances between trends in VAF and MTM per mL were observed in 8.8% of samples. These samples were derived from patients who had high total levels of cfDNA due to increased cell death from ongoing treatment. In these scenarios, MTM per mL, which accounts for total cfDNA levels, was found to be more reflective of clinical truth, as confirmed by imaging.

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 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.

The 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.

About Natera

Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, 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., 720-318-4080 pr@natera.com      

 

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SOURCE Natera, Inc.

FAQ

What are the key findings from Natera's new Signatera data presented at ASCO?

The new data showcases a >94% pre-surgical detection rate for colorectal cancer and emphasizes Signatera's effectiveness in monitoring MRD non-invasively.

When will Natera present new clinical data for Signatera?

Natera will present new clinical data at the ASCO annual meeting scheduled for June 4-8, 2021.

How does Signatera improve cancer monitoring?

Signatera's tumor-informed approach offers a highly sensitive, non-invasive method for monitoring minimal residual disease compared to standard techniques.

What is the significance of the CIRCULATE-Japan trial for Signatera?

The CIRCULATE-Japan trial represents the largest prospective MRD study, demonstrating Signatera's high detection rates and potential clinical utility in colorectal cancer.