Maximum attention on minimal residual disease

MENLO PARK, Calif.—Cancer diagnostic company GRAIL, Inc. has lined up collaborations with Amgen, AstraZeneca, and Bristol Myers Squibb centered on evaluating GRAIL's methylation-based technology for detecting minimal residual disease (MRD).

“GRAIL has developed and validated a novel approach to detect early cancer signals in blood, and now we are excited to collaborate with leading companies Amgen, AstraZeneca, and Bristol Myers Squibb to evaluate the benefits of using our technology to find minimal residual disease after treatment or to detect early recurrent cancers,” Dr. Joshua Ofman, GRAIL's chief medical officer and head of external affairs, commented in a statement. “Cancer never quits, making the detection of residual disease and early recurrences critical to helping patients and care providers stay ahead of the disease.”

“We are committed to leveraging the latest science and technologies to bring continued innovation to the healthcare community and patients we serve,” said Sarah Hersey, vice president of Precision Medicine, Translational Medicine at Bristol Myers Squibb. “Our collaboration with GRAIL and other leaders in the industry will help enhance our ability to address the outstanding challenges of detecting and treating cancer head-on.”

MRD testing is used in clinical and research applications in cancer to detect the presence or absence of residual disease, or cancer cells that survived after treatment. Some of those tests for solid tumors require tissue samples and the development of patient-specific assays, according to GRAIL, but the company's technology platform could lead to a blood-based MRD detection assay for solid tumors that could match patient-specific tissue-based assays with reduced turnaround times.

“Amgen is pleased to partner with GRAIL to understand how this technology can provide deeper insights into tumor biology and a patient’s prognosis,” Narimon Honarpour, vice president of Translational Medicine at Amgen, remarked regarding the collaboration. “Achieving better clinical outcomes relies upon our understanding of cancer progression and the field needs more robust testing capabilities.”

“Research has shown that we can improve outcomes across cancer types by treating patients as early as possible and intervening early if cancer recurs, which underpins our strategy,” added Carl Barrett, vice president of Translational Science, Oncology R&D, AstraZeneca. “This collaboration with GRAIL will allow us to test a promising approach for monitoring MRD and detecting recurrence—tools that will provide critical information that we hope can optimize patient treatment plans.”

On the same day, GRAIL shared additional related news, announcing that it expects to launch Galleri, its multi-cancer early detection blood test, in Q2 2021.

GRAIL completed enrollment for PATHFINDER—a  prospective, 6,600-participant multi-site interventional study evaluating the use of Galleri in clinical practice—in December. The study has completed its second planned independent Data and Safety Monitoring Board review, and initial results and clinical validation data from GRAIL's foundational Circulating Cell-free Genome Atlas study are expected in H1 2021.

An earlier version of Galleri was capable of detecting more than 50 types of cancer—more than 45 of which do not have recommended screening tests—with a false-positive rate of less than 1 percent. According to GRAIL, Galleri can also determine the location of the disease in the body with high accuracy.

“Cancer remains the second-leading cause of death, in large part because we lack recommended screening tests for the majority of deadly cancers. We are excited by the progress made in our mission to detect cancer earlier and what’s to come with the introduction of Galleri this year,” stated Hans Bishop, CEO of GRAIL. “We are encouraged by the significant early interest in Galleri from health systems, medical practices, and self-insured employers.”