New Published Study Further Demonstrates the Ability of Natera's mPCR Technology to Monitor Immunotherapy Response in Metastatic Uveal Melanoma Patients

ctDNA reduction at week nine in patients treated with tebentafusp was associated with improved overall survival

AUSTIN, Texas, Nov. 21, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the publication of a new study in Nature Medicine, which shows that its mPCR technology is able to assess response to tebentafusp in treatment-refractory metastatic uveal melanoma. The findings indicated an association between early reductions in ctDNA and longer overall survival, suggesting that traditional radiographic-based response criteria don't accurately reflect tebentafusp-related clinical activity and benefit. The full study can be found here.

The study reports results from a multi-center, single-arm, open-label phase 2 study of tebentafusp in 127 patients with previously treated metastatic uveal melanoma – an aggressive, but rare, cancer of the eye. Despite an overall response rate of 5%, the median overall survival (16.8 months) was more than double that of previous studies,1 suggesting the need for additional tools to help predict outcomes.

Key takeaways from the study include:

• Pre-treatment ctDNA levels are strongly correlated with tumor burden and prognosis; below-median levels had longer overall survival compared with the subset with above-median levels (HR 0.23).
• Reduction in ctDNA levels at week nine is associated with greater improvement in overall survival, even in patients with apparent radiographic progression (HR 0.47).
• The 1-year overall survival in patients with ctDNA clearance was 100% compared with 52% in those with increased ctDNA.

"We're excited to see another study showing the potential for ctDNA-based technology to monitor immunotherapy response," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "This study redemonstrates the broad utility of ctDNA as a reliable pan-cancer biomarker of disease status."

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 include statements regarding the potential for ctDNA-based technology to monitor immunotherapy response and the utility of ctDNA as a reliable pan-cancer biomarker of disease status, and quotes of management, which 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 the results of clinical or other studies may not support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests may prove to be inaccurate, or the benefits of our tests and product offerings to patients, providers and payers may be less than we expect. 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: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

References

1. Rantala, E. S., Hernberg, M. & Kivelä, T. T. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. 29, 561–568 (2019).

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SOURCE Natera, Inc.