Natera Signs Agreement with Bristol-Myers Squibb to Investigate Signatera™ ctDNA Assay as a Potential Biomarker for Opdivo (nivolumab) in a Prospective Phase 2 Adjuvant Non-Small Cell Lung Cancer Clinical Trial

SAN CARLOS, Calif., Sept. 13, 2018 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced an agreement with Bristol-Myers Squibb to use Natera's Signatera™ custom circulating tumor DNA (ctDNA) assay in a Phase 2 study in the adjuvant non-small cell lung cancer (NSCLC) setting.

The study will use the Signatera ctDNA assay to select patients who have minimal residual disease (MRD) after surgical resection to receive adjuvant standard of care with or without Opdivo (nivolumab). The first patient is anticipated to enroll in 2019 once Natera completes validation of its Signatera ctDNA assay under the Clinical Laboratory Improvement Amendments (CLIA). This study represents the first prospective clinical trial using Natera's Signatera ctDNA assay in adjuvant NSCLC.    

The study is being led by Charles Swanton, M.D., Ph.D., Senior Group Leader, Translational Cancer Therapeutics Laboratory, Francis Crick Institute, London. Natera's previous research collaboration with Dr. Swanton and the UCL Cancer Institute team in the TRACERx study, which culminated in a publication in Nature in 2017,¹ was important for the development and early clinical validation of Natera's approach in NSCLC.

Lung cancer is the second most common cancer (excluding skin cancer), and is the leading cause of cancer death in the U.S.² Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.² The five-year survival rate is 56 percent when localized and detected early; however, 16 percent of cases are detected at this stage.³ The five-year survival rate for non-localized tumors, which have spread to other organs, is only 5 percent.³   

"We are excited to use our ctDNA assay to potentially help define a new way to detect and treat early-stage lung cancer patients," said Alexey Aleshin, M.D., M.B.A., Oncology Medical Director, Natera. "We are also pleased to have been chosen as the first ctDNA assay to be used in a prospective outcomes study to inform adjuvant NSCLC treatment."

"Our goal is to potentially use the learnings from this study to serve as Natera's framework with other companies to investigate novel approaches from the metastatic setting in early-stage treatment," said Matthew Rabinowitz, Ph.D., Natera CEO. "We believe that our technology will potentially enable treatment selection for patients most likely to benefit."

Natera estimates that there are approximately 12.6 million people in the U.S. who have been diagnosed with early-stage cancer across tumor types.^3,4 In addition to this trial, 24 studies have been signed so far with 19 companies, covering most of the top ten pharmaceutical companies. These studies include prospective trials correlating clinical response with ctDNA levels for personal cancer vaccines, as well as targeted therapies. Combined with previously disclosed investigator-initiated studies in breast, lung, colorectal, and bladder cancer, these studies lay the foundation for Signatera's clinical validation as a pan-cancer assay.

About Signatera

Signatera (RUO) is the first ctDNA assay custom-built for treatment monitoring and minimal residual disease assessment. The Signatera (RUO) methodology differs from currently available liquid biopsy assays, which test for a panel of genes independent of an individual's tumor. Signatera (RUO) provides each patient with a customized blood test tailored to match the mutations found in that individual's tumor tissue, which maximizes sensitivity and specificity. Signatera (RUO) also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.

A recent study demonstrated the Signatera (RUO) method's ability to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small cell lung cancer (NSCLC) with 93 percent sensitivity and zero false positives.¹ Additional research presented at the 2018 American Association for Cancer Research meeting showed successful results from bladder and colorectal cancer studies, including median detection points of ctDNA that were 4.3 and 7.9 months, respectively, ahead of clinical relapse detection.^5,6

About Natera

Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.

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 studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening 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, 650-249-9090
Media: Barbara Sullivan, Sullivan & Associates, 714-374–6174, [email protected]

References

1. Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017)http://doi.org/10.1038/nature22364.
2. American Cancer Society. https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/key-statistics.html Accessed September 4, 2018
3. American Lung Association. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.html Accessed September 4, 2018
4. Natera estimates based on data from National Cancer Institute SEER Program Website.https://seer.cancer.gov/statistics/ Accessed September 4, 2018
5. Birkenkamp-Demtröder K, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; AACR; 2018. Abstract 3653.
6. Andersen C, et al. Personalized circulating tumor DNA analysis to monitor colorectal cancer [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; AACR; 2018. Abstract 159

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