Data from the largest real-world MRD study to date in resectable colorectal cancer reinforces the findings from the recent CIRCULATE-Japan study
AUSTIN, Texas, Sept. 12, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, today announced new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the 2022 European Society for Medical Oncology (ESMO) World Congress, taking place September 9-13 in Paris, France.
Signatera data was presented in 4 abstracts, including both oral and poster presentations. These include results from a real-world study on colorectal cancer (CRC) patients as well as an early readout from the BELLINI trial that highlights how circulating tumor DNA (ctDNA) dynamics can help inform neoadjuvant treatment decision-making in hormone receptor negative, HER2 negative (triple-negative) breast cancer (TNBC). The key highlights are below:
Abstract # 1828 | Late-Breaking Oral Presentation | Presenter: Marleen Kok
Nivolumab and ipilimumab in early stage triple negative breast cancer (TNBC) with tumor-infiltrating lymphocytes (TILs): first results from the BELLINI trial
This study evaluates the potential clinical utility of ctDNA in assessing the response to neoadjuvant immunotherapy in patients with early stage (I-II) TNBC. Thirty patients were treated with two cycles of the immune checkpoint inhibitor (ICI) nivolumab, alone or in combination with ipilimumab, prior to the start of neoadjuvant chemotherapy. Response to ICIs was evaluated radiographically, as well as through the analysis of ctDNA dynamics. All of the patients who achieved partial response by imaging presented with 50-100% reduction in ctDNA levels compared to pretreatment, while increasing or stable ctDNA levels were observed in non-responders.
“The BELLINI trial supports MRD testing for early, reliable immunotherapy response monitoring in the neoadjuvant TNBC setting,” said Dr. Minetta Liu, Natera’s chief medical officer of oncology. “We are very encouraged by the data generated through our collaboration with Dr. Kok and colleagues, and we look forward to ongoing work to push the boundaries of chemotherapy de-escalation.”
Abstract # 319MO | Mini Oral Presentation | Presenter: Stacey A. Cohen
Real world monitoring of circulating tumor DNA reliably predicts cancer recurrence in patients with resected stages I-III colorectal cancer
In this retrospective analysis of a real-world cohort of 16,347 patients with early stage colorectal cancer, MRD status was assessed using the Signatera test after surgery and during surveillance. Complete clinical information was available for a subset of 417 patients, and showed that postoperative MRD-positive status was significantly associated with inferior recurrence-free survival. Patients who were MRD-negative showed no significant benefit from adjuvant chemotherapy, regardless of other risk factors such as stage, age or microsatellite instability status.
“The results from this large, real-world dataset reinforce those from the CIRCULATE-Japan study presented earlier this year, and provide further evidence for the potential value of MRD testing in the clinic,” said the study’s principal investigator, Dr. Stacey Cohen of the Fred Hutchinson Cancer Center. “Incorporating MRD testing into the standard of care for CRC may better identify the patients with a high risk of recurrence – enabling timely intervention, while sparing those who would not benefit from unnecessary treatment.”
Abstract # 1649P | Poster Presentation | Presenter: Danica Vodopivec Kuri
A proof-of-concept study for detecting ctDNA in rare thyroid cancers
Abstract # 728O | Oral Presentation | Presenter: Omid Hamid
Results from phase I dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors
Signatera dynamics used to assess therapy response across multiple tumor types.
