Grail says positive results from PATHFINDER 2 study to be presented at ESMO

Grail (GRAL) announced that positive performance and safety results from its registrational PATHFINDER 2 study are being presented at the European Society for Medical Oncology Congress 2025. PATHFINDER 2 evaluated the safety and performance of the Galleri(R) multi-cancer early detection (MCED) test when used alongside standard-of-care cancer screenings. The largest interventional study of an MCED test in the United States to date, the prospective PATHFINDER 2 study includes 35,878 enrolled participants across the United States and Canada in a broad, intended-use population of adults aged 50 and older with no clinical suspicion of cancer. Results were presented from a pre-specified analysis of the first 25,578 participants with at least 12 months of follow-up as of Dec. 31, 2024. Of these, 23,161 were analyzable for performance and 25,114 were analyzable for safety. “Cancer is the second leading cause of death worldwide as most deadly cancers are found too late. Adding Galleri to recommended screening for breast, cervical, colorectal, and lung cancers in PATHFINDER 2 yielded a more than seven-fold increase in the cancer detection rate, and more than half of the Galleri detected new cancers were found in early stages, when cancers are more treatable and potentially even curable. Galleri’s ability to accurately predict where in the body the cancer signal comes from also helps to guide a more efficient diagnostic workup,” said Josh Ofman, MD, MSHS, President at GRAIL. “These results are extremely compelling as approximately three-quarters of the Galleri-detected cancers do not have recommended screening tests today. Galleri is the only MCED test available that has been validated in an interventional trial in the screening population and could transform how we deliver cancer screening at a population level.”