On September 8, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported final results from the interventional PATHFINDER study will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris (Press release, Grail, SEP 8, 2022, View Source [SID1234619286]). PATHFINDER data evaluating the Galleri multi-cancer early detection (MCED) blood test will be shared in a September 11 proffered paper session. Participant-reported outcomes will also be presented, including satisfaction related to MCED testing, ongoing adherence with standard of care screening, and information related to participants’ anxiety and distress. Interim results from the PATHFINDER study were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The PATHFINDER single-arm interventional study was designed to evaluate the clinical care pathways following a "cancer signal detected" Galleri test result, measure the time required to achieve diagnostic resolution (primary endpoint), and assess the implementation and performance of Galleri in a clinical care setting.

"Despite 50 years of waging a war on cancer, cancer is poised to become the world’s number one killer, in large part because most cancers are diagnosed too late. While current screening tests are saving lives, they are not enough, and the status quo in cancer screening is simply unacceptable. In the United States, we routinely screen for only five cancers yet most cancer deaths occur from cancers we are not looking for. Our current approach using decades old technology with suboptimal adherence is simply not finding enough cancer in the population. We must transition from only looking for individual cancers to also looking at individuals for many cancers," said Josh Ofman, MD, MSHS, president at GRAIL. "We are excited to share the final PATHFINDER results, which provide important insights about the feasibility of our first-of-its-kind MCED technology, the clinical care pathways following a "cancer signal detected" result, and Galleri’s potential to detect more cancers in their earlier stages as a complement to standard screenings."

The PATHFINDER study enrolled 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer, but with no suspicion of active cancer. Participants were enrolled across 11 sites, including the Cleveland Clinic, Dana-Farber Cancer Institute, Mayo Clinic, Oregon Health & Science University, Sutter Health and the US Oncology Network. Results will be presented from both an earlier version of Galleri (MCED-E) and a pre-specified retrospective analysis evaluating the current version of the Galleri test (MCED-Scr) using banked blood samples.

Selected GRAIL presentations at ESMO (Free ESMO Whitepaper) include:

A Prospective Study of a Multi-Cancer Early Detection Blood Test (Presentation #903O)

Session Type: Proffered Paper Session
Date/Time: Sunday, Sept. 11, 16:30 – 16:40 p.m. CEST (10:30 – 10:40 a.m. EST)
Location: 7.3.O – Orleans Auditorium
Speaker: Deborah Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK)

Evaluation of Anxiety, Distress and Satisfaction With a Multi-Cancer Early Detection Test (Presentation #908P)

Session Type: e-Poster
Date/Time: Sunday, Sept. 11
Speaker: Deborah Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK)

Time to Diagnosis Among Patients with Cancer in the US (Presentation #1318MO)

Session Type: Mini Oral Session
Date/Time: Monday, Sept. 12, 17:10 – 17:15 CEST (11:10 – 11:15 a.m. EST)
Location: 7.3.M – Marseille Auditorium
Speaker: Matthew Gitlin, PharmD, BluePath Solutions

Abstracts are available on the ESMO (Free ESMO Whitepaper) Congress 2022 website. Additional data from the PATHFINDER study will be presented at the Congress.

About GRAIL’s MCED Clinical Development Program

The Galleri clinical development program consists of studies that collectively include more than 335,000 participants – and what is believed to be the largest linked datasets of genomic and clinical data in the cancer field. GRAIL’s program includes the foundational CCGA development and validation study, the interventional PATHFINDER and PATHFINDER 2 studies, the NHS-Galleri randomized, controlled clinical study, the STRIVE and SUMMIT observational studies, and the REFLECTION real-world registry. The largest of these, the NHS-Galleri trial, has enrolled 140,000 participants with the primary objective of a reduction in late-stage cancer diagnoses, thought to be a necessary prerequisite for a mortality reduction.