Aveta Biomics will use Natera’s Signatera ctDNA test as a minimal residual disease (MRD) endpoint in its Phase III head and neck squamous cell carcinoma program, APG-157. The study will enroll up to 826 patients across resectable and unresectable cohorts and randomize participants to APG-157 versus standard of care. Aveta said the ctDNA assay will be used to assess responses during treatment and to validate molecular findings from an earlier Phase II trial, supporting future regulatory submissions. Signatera has also gained FDA approval as a companion diagnostic for Genentech’s Tecentriq in bladder cancer. The Phase II dataset presented previously at ASCO included pathological response in 77% of patients and tumor shrinkage of at least 30% in four patients, with no Grade 3 or higher adverse events reported. Additional analysis presented at AACR linked APG-157 to reduced HPV viral load and activation of a pathway associated with lower metastasis risk. For MRD-driven oncology strategies, embedding ctDNA readouts into pivotal designs continues to expand the practical role of liquid biopsy assays in differentiation and regulatory evidence packages.
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