A lot of factors come into play in looking at the efficiency of clinical trials. Many trials, especially for cancer, require genotyping prospective enrollees to determine eligibility for a study. A press release from Guardant Health, Inc. offers evidence of one way to improve this process. Traditionally, the genotyping was done via biopsy, in which a portion of suspected cancers are removed surgically. Guardant has an alternative: the Guardant360 Liquid Biopsy product allows use of a blood draw instead of a biopsy. Now, a new study shows that a liquid biopsy protocol more than doubles trial-enrollment rates and offers other benefits. The research, led by the National Cancer Center Hospital East in Japan, looked at both biopsy methods in the context of gastrointestinal cancer. The “liquid” biopsy was found to be accurate in genotyping tumors, to accelerate trial enrollment, to find more key gene changes, and finally, to achieve similar treatment results.
Screening Time and Enrollment Rates Improved
Known as “SCRUM-Japan GOZILA,” the study compared liquid to traditional biopsies for trial-enrollment genotyping. Subjects with advanced gastric or colorectal cancer were matched to therapies that, “target the specific biomarkers identified.” Results included shortened screening time from a median 33 days to 11 days and improved trial enrollment rates from 4.1% to 9.5%. The liquid option also, “revealed more actionable alterations because of its high success rate and ability to detect heterogeneously-distributed mutations which are often missed by single-locus tissue analysis.” Even more importantly, similar rates of positive responses to treatment and, “progression-free survival.”
FDA Approves Liquid Biopsy in August
Dr. Yoshiaki Nakamura, Principal Investigator, noted, “The data demonstrate that genomic profiling by ctDNA (circulating tumor DNA) analysis using the Guardant360 liquid biopsy has the advantage of shorter turnaround times and improved patient enrollment compared to tissue biopsy for clinical trials, without compromising treatment efficacy. The paradigm of precision oncology should be shifted toward greater use of liquid biopsies.” AmirAli Talasaz, Ph.D., Guardant’s President opined, “These data complement other studies supporting the routine use of the Guardant360 test in personalized treatment decisions for patients with advanced cancer, and its potential to significantly accelerate the development and delivery of innovation in precision medicine to patients.” The 360 product was approved in August by the FDA for tumor profiling, known as comprehensive genomic profiling. Guardant Health AMEA (Asia, Middle East and Africa) is a joint venture between Softbank and Guardant Health, Inc.