Predicine, a developer in the field of liquid biopsy, announced a new study published in The New England Journal of Medicine (NEJM), demonstrating the clinical utility of its minimal residual disease (MRD) liquid biopsy assay in support of Genentech’s Phase 1 Clinical Trial of Divarasib.
In this global Phase 1 clinical trial of Divarasib, Predicine’s tumor-naïve, blood-informed MRD solution, PredicineBEACON, played a central role in assessing the safety and efficacy of the treatment. The trial results confirmed response rates observed in patients with non-small cell lung cancer (NSCLC) (56%), colorectal cancer (CRC) (36%), and other solid tumors (36%) at the highest dose.
What sets this biomarker study apart is the blood-informed circulating tumor DNA (ctDNA) profiling at the ultra-deep MRD level using Predicine’s proprietary liquid biopsy next-generation sequencing (NGS) platform, the company says. PredicineBEACON, a tumor naïve, personalized minimal residual disease (MRD) assay, enabled precise monitoring of genomic alterations and emerging resistance mechanisms.
The longitudinal assessment of circulating tumor DNA at the MRD level (100,000X sequencing depth) revealed declines in KRAS G12C variant allele frequency, strongly associated with positive treatment response. Additionally, this analysis identified genomic alterations that may contribute to resistance to Divarasib. Remarkably, a reduction in KRAS G12C variant allele frequency was observed as early as day 15 of cycle 1. Importantly, the study highlights the correlation between the molecular dynamics of KRAS G12C mutation and complete or partial responses to Divarasib across all three tumor types (NSCLC, CRC, and other solid tumors). These findings underscore the clinical utility of liquid biopsy profiling in the assessment of phase I clinical trial of Divarasib.
“As a physician, I’m constantly searching for tools that can provide deeper insights into our patients’ conditions. Liquid biopsy has been a game-changer in our approach to cancer care. It offers a minimally invasive yet highly informative window into the molecular landscape of tumors. It’s transforming how we understand and treat solid tumors. Liquid biopsy holds tremendous promise for patients,” says Jayesh Desai, MBBS, FRACP, from Peter McCullum Cancer Center, who is the corresponding author of this study.
Further reading: Predicine Liquid Biopsy Outperforms in ctDNA Assay Study
“We are delighted to witness the significant clinical impact of Predicine’s blood-informed MRD liquid biopsy solutions in the context of Genentech’s Phase 1 clinical trial of Divarasib,” says Shidong Jia, MD, PhD, founder & CEO of Predicine. “This milestone publication with Divarasib is a testament to the power of Predicine’s unique liquid biopsy technology to advance precision oncology and clinical trials.”
The publication can be found online at: Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation – PubMed (nih.gov)