Natera, Inc. Launches Multi-Center Randomized Trial Using Signatera MRD Testing in Stage II-III Colorectal Cancer
January 15, 2020 at 08:42 am EST
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Natera, Inc. 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 1,500 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), introduced as a sequel to the pivotal IDEA collaboration of 2007-2017 which compared outcomes from 3 months versus 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. 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%.
Natera, Inc. is a diagnostics company, which is focused on the development and commercialization of molecular testing services, applying its technology in the fields of womenâs health, oncology and organ health. Its cell-free deoxyribonucleic acid (cfDNA) technology combines its molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell. The Company's product offerings include Panorama Non-Invasive Prenatal Test (NIPT), Vistara, Horizon Carrier Screening, Spectrum Preimplantation Genetics, Anora Miscarriage Test, Empower, and Prospera. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Companyâs algorithms and bioinformatics in order to validate and launch tests based on the Companyâs technology. Its NIPT screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother.
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