In the LIONESS study, blood samples taken from 17 patients with stage 3-4B, p16-negative HNSCC who received curative-intent primary surgical treatment were tested using RaDaR to detect circulating tumor DNA (ctDNA) as evidence of minimal residual disease (MRD) and recurrence pre- and post-surgery.
The company said all patients had detectable ctDNA prior to surgery (100% clinical detection).
In monitoring after surgery, ctDNA was detected in five patients at low levels, consistent with previous studies utilizing RaDaR in breast and lung cancer.
The company added that ctDNA was detected prior to progression in all five patients with clinical recurrence, with lead times ahead of clinical confirmation ranging from 108 to 253 days.
In the remaining 12 patients there was no recurrence detected, indicating a 100% clinical specificity of the RaDaR assay and confirming post-operative tumor clearance.
“The assay showed exceptionally high sensitivity, detecting ctDNA in every HNSCC patient who went on to recur, which along with its specificity demonstrates the potential of RaDaR to identify HNSCC patients at an increased risk of relapse, enabling earlier intervention and personalized therapy planning,” said Inivata’s Chief Medical Officer David Eberhard.
The data from the Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS) study were published in the British Journal of Cancer.