Tracking circulating tumor DNA with the MinerVa Prime assay predicted disease return months ahead of clinical detection in early-stage lung cancer patients, according to study results published in Nature Communications.
Researchers evaluated 1,352 plasma samples from 175 patients enrolled in the phase 3 EVIDENCE trial. The cohort included individuals with stage II to IIIA resected EGFR-mutated non-small cell lung cancer who received either adjuvant icotinib or chemotherapy. Testing was conducted using the MinerVa Prime assay, a personalized tumor-informed molecular residual disease (MRD) platform developed by Genecast Biotechnology.
At the landmark timepoint, the assay detected MRD positivity in 35.8% (38 of 106) of stage III patients and 14.7% (10 of 68) of stage II patients. Across continuous monitoring, the longitudinal positivity rate reached 47.4%. Patients testing positive for MRD showed significantly worse disease-free survival at both the landmark stage (hazard ratio 4.44, P < 0.001) and during longitudinal monitoring (hazard ratio 7.82, P < 0.001).
Icotinib delivered disease-free survival advantages over chemotherapy across both MRD subgroups. The targeted therapy increased MRD clearance in MRD-positive patients and lowered molecular recurrence among landmark MRD-negative patients. Longitudinal MRD tracking achieved a 91.3% negative predictive value, identifying return of disease with a median lead time of 169 days prior to clinical recurrence.
Serial monitoring identified test status at 24 weeks post-randomization as having the highest prognostic value. Funding for the study came from the National Key R&D Program of China, the Natural Science Foundation of Shanghai, and regional programs in the Shanghai Pudong New Area.
