Natera announces new study on its personalized, tumor-informed MRD test

Natera 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. This study analyzed 555 prospectively collected plasma samples from 69 patients with stages III-IV melanoma, analyzed in three cohorts. Key takeaways include: Cohort A: Resectable stage III patients receiving immunotherapy or observation in the adjuvant setting: MRD positivity post-resection was associated with significantly shorter distant metastasis-free survival, and identified patients most likely to benefit from adjuvant therapy. Signatera detected recurrence with an average lead time of 3 months over standard imaging. Cohort B: Unresectable stage III/IV patients receiving immunotherapy: An increase in ctDNA levels 3-11 weeks after starting immune checkpoint inhibitor therapy was associated with significantly shorter progression-free survival. All patients with increasing ctDNA experienced disease progression, while all patients with decreasing ctDNA achieved complete or partial response. In two patients, Signatera also correctly differentiated between true progression vs. pseudo-progression. Cohort C: Stage III/IV patients in surveillance after completion of immunotherapy: 100% of patients who were ctDNA-negative during surveillance remained progression-free until the last follow up, while all ctDNA-positive patients experienced disease progression. "This collaborative analysis of real-world data supports the prognostic and predictive value of Signatera in the clinical management of melanoma patients after surgery, and those receiving an immune checkpoint inhibitor," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "It is critical to balance treatment-related benefit with toxicity, and ctDNA assessment by Signatera provides a means by which to predict and evaluate benefit from immunotherapy in melanoma, the deadliest of all skin cancers."