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PGDx Liquid Biopsy Assay to be Used in Cancer Drug Study

NEW YORK (GenomeWeb) — Personal Genome Diagnostics announced today that its non-invasive pan-cancer plasma assay will be used in a clinical trial evaluating Bristol-Myers Squibb's cancer drugs Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with specific genetic mutations.

The trial — called Nivolumab, Ipilimumab in Patients With Hyper Mutated Cancers Detected in Blood, or NIMBLe — is designed to test Opdivo alone or in combination with Yervoy in 100 patients with metastatic or unresectable tumors harboring mutations in the POLE and POLD1 genes. Such mutations are associated with increased rates of mutation in tumor DNA, as well as improved patient responses to the two drugs.

According to Baltimore, Maryland-based PGDx, blood and tumor tissue samples will be collected from study participants, and will be analyzed to determine the correlation between mutations detected in a tumor tissue samples and those detected in blood using the company's assay. The study is being led by the Cancer Research Institute and Canadian Cancer Trials Group, PGDx said. Trial sites in the US and Canada are expected to be opened soon.

"We've begun to understand that tumors with gene mutations like POLE and POLD1 have a high mutational burden and are investigating whether patients with this mutation may have better response and improved survival outcomes when treated with immunotherapy," John Simmons, director of translational medicine at PGDx, said in a statement. "We also know that many advanced cancer patients are often unable to provide tissue samples, which can limit the ability to use genomic testing to help guide their treatment decisions. We're excited to collaborate on this innovative study."

In July, PGDx received a Breakthrough Device Designation from the Food and Drug Administration for its PGDx Elio Plasma Resolve cell-free DNA assay. And in April, PGDx partnered with Five Prime Therapeutics to develop a blood-based companion diagnostic assay for use the investigational cancer drug candidate bemarituzumab.