Pivotal Study of 1500 Patients Could Lead to Change in Practice Guidelines
SAN CARLOS, Calif., Jan. 15, 2020 /PRNewswire/ — Today Natera, Inc. (NASDAQ: NTRA) announced an agreement with the National Cancer Center (NCC) Japan to launch the CIRCULATE-IDEA trial in Japan, a prospective, multi-center, randomized trial to investigate ctDNA-guided treatment strategies for patients with Stage II-III colon cancer, based on the results of molecular residual disease (MRD) testing with Signatera. The trial is organized by the NCC and national in scope, and it is expected to include approximately 1500 patients from over 100 cancer centers across Japan.
The CIRCULATE-IDEA trial was unveiled in September 2019 at the annual congress of the European Society for Medical Oncology (ESMO),1 introduced as a sequel to the pivotal IDEA collaboration of 2007-2017 which compared outcomes from 3 months vs. 6 months of adjuvant chemotherapy in patients with Stage III colon cancer. The CIRCULATE-IDEA trial picks up where the IDEA trial left off, with groups across Japan, the U.S. and Europe collaborating to explore optimal treatment strategies in the era of personalized, tumor-informed MRD testing.
There will be multiple investigational arms in the Japanese CIRCULATE-IDEA trial, including treatment escalation (experimental therapies) in patients who test MRD-positive after surgery, and treatment de-escalation (no chemotherapy at all) in patients who test MRD-negative after surgery. The study’s primary objective is to demonstrate that MRD-negative patients derive no significant clinical benefit from adjuvant chemotherapy and thus may safely avoid it. This outcome, if achieved, would result in a significant change to current medical practice, in which adjuvant chemotherapy is standard for all Stage III patients despite the fact that most patients are cured by surgery alone.
In Japan, CIRCULATE-IDEA is the centerpiece of a new platform study called SCRUM-Japan MONSTAR-SCREEN. If successful, the platform study is expected to support widespread adoption and reimbursement of MRD testing in Japan.
"There are many thousands of colon cancer patients each year who receive unnecessary chemotherapy," said the study’s Principal Investigator, Dr. Takayuki Yoshino of the NCC East, Kashiwa, Japan. "We believe the Signatera technology offers a breakthrough solution to differentiating which patients need further treatment and which do not."
In a published validation study, Signatera detected relapse in patients with Stage II-III colorectal cancer up to 16.5 months earlier (average 8.7 months earlier) than standard diagnostic tools including CT imaging and CEA. Patients who remained MRD-negative throughout the study had significantly reduced risk of relapse, as low as 3%.2
"We are proud to partner with the NCC and the Japanese oncology community on this important trial," said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director for Oncology. "Helping patients avoid unnecessary treatment is a cornerstone of our vision for Signatera across many cancer types, and we believe this collaboration is an early example of how that story will unfold globally."
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 clinical and research use, and in 2019 it was granted Breakthrough Device Designation by the FDA. 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. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather it is intended to detect and quantify how much cancer may be left in the body, to detect recurrence earlier, and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.
Signatera was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to obstetricians, oncologists, transplant nephrologists, academic researchers, drug developers, and genetic laboratories through its cloud-based software platform. Natera’s flagship cancer assay, Signatera, was designated by the FDA as a Breakthrough Device in 2019. For more information, visit www.natera.com, or follow Natera on LinkedIn.
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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kevin Knight, 206-451-4823, email@example.com
- Yoshino T. New IDEA Collaboration "CIRCULATE IDEA", Adjuvant treatment duration for high-risk stage II colon cancer. ESMO 2019 Congress, Barcelona, Spain. Presented on September 30, 2019.
- Reinert T, Henriksen T, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124-1131
SOURCE Natera, Inc.