Press release
New Publication Demonstrates Utility of Natera’s Signatera™ Test in Melanoma
Real-world findings from >550 plasma samples highlight prognostic and predictive value of Signatera for adjuvant decision-making and immunotherapy monitoring
About this update from Natera, Inc.
[{"type":"text","content":"\nReal-world findings from >550 plasma samples highlight prognostic and predictive value of Signatera for adjuvant decision-making and immunotherapy monitoring\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Cancer showing the prognostic and predictive utility of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to inform adjuvant treatment decisions and monitor for recurrence and therapy response in patients with stages III-IV melanoma. The full study can be found here.\n\nThis study analyzed 555 prospectively collected plasma samples from 69 patients with stages III-IV melanoma, analyzed in three cohorts. Key takeaways include:\n\n\nCohort A: Resectable stage III patients receiving immunotherapy or observation in the adjuvant setting:\nMRD positivity post-resection was associated with significantly shorter distant metastasis-free survival (HR=10.77; p=0.01), and identified patients most likely to benefit from adjuvant therapy. Signatera detected recurrence with an average lead time of 3 months over standard imaging.\n\n\nCohort B: Unresectable stage III/IV patients receiving immunotherapy:\nAn increase in ctDNA levels 3-11 weeks after starting immune checkpoint inhibitor therapy was associated with significantly shorter progression-free survival (HR=22; p=0.006). All patients with increasing ctDNA experienced disease progression (4/4), while all patients with decreasing ctDNA achieved complete or partial response (15/15). In two patients, Signatera also correctly differentiated between true progression vs. pseudo-progression.\n\n\nCohort C: Stage III/IV patients in surveillance after completion of immunotherapy:\n100% (7/7) of patients who were ctDNA-negative during surveillance remained progression-free until the last follow up (median 14.67 months), while all ctDNA-positive patients (3/3) experienced disease progression.\n\n\n“ctDNA is emerging as a potential biomarker for informing adjuvant treatment decisions and assessing treatment response in metastatic disease in real-time,” said Zeynep Eroglu, M.D., medical oncologist in the department of cutaneous oncology at Moffitt Cancer Center and lead author of the study. “Our study shows the potential for a personalized, tumor-informed ct...