A clinical-trial paper on cancer genomic medicine supported by the Japan Agency for Medical Research and Development (AMED), co-first-authored by Takaaki Mizuno, CEO of CLINIAL Inc. (Shibuya-ku, Tokyo) — “Upfront liquid biopsy in patients with advanced solid tumors who were not feasible for tissue-based next-generation sequencing” — has been published in the Japanese Journal of Clinical Oncology (Volume 55, Issue 7, Pages 720–728).
This study is a prospective clinical trial that verified the feasibility and clinical usefulness of performing a liquid biopsy before the start of standard treatment in patients with advanced solid tumors for whom tissue-based next-generation sequencing (NGS) is difficult. A total of 109 patients across six cancer types — lung, pancreatic, biliary tract, gastric, colorectal, and triple-negative breast cancer — were enrolled, and comprehensive genomic analysis using circulating tumor DNA in the blood (Guardant360) was performed.
As a result, the success rate of liquid biopsy was extremely high at 99.1%, and the median time from blood draw to result return was 7 days (range 5–22 days), demonstrating a turnaround time sufficient for use in clinical settings. Actionable genetic alterations that could become treatment targets were detected in 28.4% of all patients, and of these, 8.3% received matched therapies such as molecular targeted drugs based on the test results. Even limiting the analysis to treatment-naïve cases, actionable mutations were found in 29.8%, and 8.5% were connected to therapies targeting the genetic alterations.
The study results suggest that “in patients with advanced solid tumors for whom tissue-based NGS is difficult, performing a liquid biopsy before first-line treatment is useful for detecting genetic alterations relevant to treatment selection and for considering molecular targeted therapy,” indicating that it can become a new genomic-medicine option for patients from whom tissue specimens are difficult to obtain.
CLINIAL will apply the knowledge gained from this study to the appropriate timing of cancer genomic testing and to the development of data foundations and products that connect test results to treatment selection, contributing to a healthcare system in which the opportunity for molecular targeted therapy reaches more patients beyond the constraints of tissue specimens.
(Reference)
Upfront liquid biopsy in patients with advanced solid tumors who were not feasible for tissue-based next-generation sequencing | Japanese Journal of Clinical Oncology | Oxford Academic
https://academic.oup.com/jjco/article-abstract/55/7/720/8116335
Upfront liquid biopsy in patients with advanced solid tumors who were not feasible for tissue-based next-generation sequencing - PubMed
https://pubmed.ncbi.nlm.nih.gov/40251768/