On March 21, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported new Signatera data from the prospective, multi-center CIRCULATE-Japan trial, reported by Dr. Eiji Oki of Kyushu University in an oral presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care (Press release, Natera, MAR 21, 2022, View Source [SID1234610500]).

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CIRCULATE-Japan is the largest molecular residual disease (MRD)-guided clinical trial with more than 3,300 stage I-IV colorectal cancer (CRC) patients enrolled to date. This interim analysis at SSO, similar to the one previously presented at the 2022 ASCO (Free ASCO Whitepaper) GI symposium, analyzed 6-month and 12-month outcomes from 1,040 patients and showed that Signatera MRD-positive patients benefited significantly from adjuvant chemotherapy (ACT), while Signatera MRD-negative patients did not benefit from ACT.

Latest findings exclusive to SSO 2022 demonstrate 75% (45/60) detection of recurrence in stage II-III patients with a single blood draw at 4 weeks post surgery. The previous analysis from ASCO (Free ASCO Whitepaper) GI, which showed a single time point sensitivity of 68% (46/68), did not exclude non-cancer or treatment-related deaths. Prior studies have shown that serial monitoring further increases the detection rate of recurrence up to 88-93%.1,2

"Learnings from our study consistently suggest that stratifying post-surgical treatment decisions using Signatera can identify patients likely to benefit from adjuvant chemotherapy across stages," said the study’s Principal Investigator, Dr. Takayuki Yoshino, of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "We look forward to continuing to expand the study."

The presentation at SSO also indicates increasing interest in and adoption of Signatera among cancer surgeons, who are finding utility in personalized monitoring and MRD assessment to inform surgical decisions. Signatera has been shown in several studies3,4 to be predictive of treatment response in the neoadjuvant setting (before surgery) as well as the adjuvant setting (after surgery), across multiple cancer types.

In addition to presenting the latest CIRCULATE-Japan study data, Natera also announced the activation of the CIRCULATE-US trial, a national, prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early-stage CRC. The study, which is being conducted in partnership with NRG Oncology and funded by the National Cancer Institute (NCI), was recently granted an investigational device exemption (IDE) from the FDA after a thorough review of Natera’s clinical and analytical validation data.

"Natera is dedicated to continuing to drive improvement in MRD test sensitivity and improving CRC patient outcomes by executing definitive, practice-changing prospective studies," said Dr. Adham Jurdi, medical director of oncology at Natera. "We’re delighted to be at the forefront of MRD and colorectal cancer research and excited to see these landmark studies, like CIRCULATE-US, progress."

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 Signatera’s 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 assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.