GRAIL Multicancer Early Detection Test Registrational Trials Make Good Progress, Company Says

The potential for multicancer early detection (MCED) testing moves another step forward today with the announcement by GRAIL that the company has completed enrollment of more than 35 000 participants in the PATHFINDINER 2 clinical trial, a cohort of adults aged 50 years and older who are eligible for guideline-recommended cancer screening. Results from the first 25 000 participants are expected in the second half of 2025, the company said.

The study, which began enrollment in December 2021, is being conducted following a FDA-approved investigational device exemption application for the Galleri MCED, according to GRAIL. In the same announcement, GRAIL said that the third and final round of study visits had been completed for a second registration trial, the NHS-Galleri study, which enrolled more than 140 000 participants.

"The PATHFINDER 2 and NHS-Galleri studies will significantly expand our existing clinical validation and performance evidence for the Galleri test. By supplementing our robust clinical evidence program with more than 35 000 participants in the US for PATHFINDER 2 and over 140 000 participants in England for NHS-Galleri, we will continue our generation of additional performance, safety, and clinical utility data," Bob Ragusa, GRAIL chief executive officer said in the news release.

Ragusa describes both studies as comprised of diverse populations, “representative of socioeconomic, ethnicity, gender and age differences…The data from these studies, as well as supplemental data from our other clinical studies, will support our premarket approval application submission for Galleri to the FDA, which is currently in process...under a Breakthrough Device Designation from the FDA.

"We look forward to seeing results from the first 25,000 individuals enrolled in the PATHFINDER 2 study in the second half of 2025 and final results from the NHS-Galleri trial in 2026."

The primary objectives of the PATHFINDER 2 study are to:

• evaluate the safety and effectiveness of GRAIL's MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result
• evaluate the performance of GRAIL's MCED test across various measures, including positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity, and cancer signal origin (CSO) prediction accuracy.

Study participants whose results indicate a signal for cancer will receive additional diagnostic testing to confirm the presence or absence of cancer, based on the predicted CSO, GRAIL explained.

The company will also evaluate the follow-up use of guideline recommended cancer screening after MCED testing as well as important patient reported outcomes including anxiety and satisfaction with the blood-based screening test.

The NHS-Galleri trial was initiated in 2021 in response to a request from the UK’s National Health Service for assistance in its exploration of methods for early cancer detection that had population screening potential. The prospective, randomized controlled clinical utility trial is evaluating the use of Galleri alongside existing NHS standard of care screenings. Of primary interest is whether use of Galleri as a method of early detection can reduced incidence of late-stage cancers. The need to promote health equity is reflected in the breadth of the population sample, which, according to GRAIL, was fully enrolled in just more than 10 months.

Half the study participants will receive the Galleri test and blood samples from the other half will be stored for future analysis. All participants for whom a cancer signal is detected are referred for additional diagnostic workup.

The Galleri test is described by GRAIL as a "proactive tool" for early identification of many of the deadliest neoplasms that don't have recommended screening protocols, including pancreatic, esophageal, ovarian, and liver. The test is designed to indicate the origin of a cancer when it is still asymptomatic so that health care professionals have a "road map" for additional exploration. The screening is recommended for people over the age of 50, or those with an elevated risk for cancer due to genetics, family history, environmental exposure, or other risk factors.

Source
GRAIL advances the Galleri registrational clinical trail program. News release. GRAIL. July 15, 2024. Accessed July 15, 2024. https://investors.grail.com/news-releases/news-release-details/grail-advances-gallerir-registrational-clinical-trial-program