On July 26, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in the Journal of Clinical Oncology highlighting the utility of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, for surveillance in Merkel cell carcinoma (MCC) (Press release, Natera, JUL 26, 2024, View Source [SID1234645114]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
MCC is an aggressive skin cancer with high mortality and a recurrence rate of 40% within 5 years.1 MRD testing using a viral antibody is recommended by the National Comprehensive Cancer Network (NCCN)2, but this tumor marker is only present in 52% of patients and has several known limitations3-4. There is an unmet need for improved MRD testing technologies that are applicable to all patients, regardless of their viral status.
This prospective, multicenter, observational study included 319 patients with stage I-IV MCC. Signatera was used to assess ctDNA levels at the time of enrollment, and every 3 months during the surveillance period. Key findings include:
Signatera showed a test sensitivity of approximately 95% for detecting clinically evident disease at time of enrollment.
ctDNA positivity during surveillance was associated with up to 20 times higher risk of recurrence than persistently ctDNA-negative patients.
At 12 months of surveillance, the recurrence-free probability was 9% among patients with a positive ctDNA result at any time, compared with 91% for patients who remained ctDNA-negative.
"There is a strong need for highly accurate biomarkers in merkel cell carcinoma, an incredibly aggressive and rare form of skin cancer," said Lisa Zaba, M.D., Ph.D., associate professor of dermatology, director of the MCC multi-disciplinary clinic and member of the supportive oncodermatology group at the Stanford Cancer Center. "Our study shows that a tumor-informed MRD test can inform prognosis and guide surveillance in patients with MCC, regardless of tumor viral status."
"We are encouraged by the excellent performance of Signatera in this study, where high prognostic accuracy was demonstrated, and where we can see the significant clinical utility of MRD testing for detecting recurrence in MCC patients," said Angel Rodriguez, M.D., senior medical director at Natera and co-author of the study. "We are optimistic that Signatera will become a standard monitoring tool in this highly lethal cancer type, enabling clinicians to select patients with MRD who might benefit most from adjuvant therapy and better determine who may or may not need more frequent imaging with a high degree of confidence."
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 70 peer-reviewed papers.