GRAIL Completes Enrollment of More Than
35,000 Participants in the PATHFINDER 2
Study;
Results From the First 25,000
Participants Expected in the Second Half of 2025
GRAIL Completes Final Study Visits for the
NHS-Galleri Trial; Final Results Expected in 2026
MENLO
PARK, Calif., July 15,
2024 /PRNewswire/ -- GRAIL, Inc. (NASDAQ: GRAL), a
healthcare company whose mission is to detect cancer early when it
can be cured, today provided an update on the PATHFINDER 2 and
NHS-Galleri registrational clinical trials evaluating the
Galleri® multi-cancer early detection (MCED) test. GRAIL
has completed the PATHFINDER 2 study's planned enrollment of more
than 35,000 participants who are eligible for guideline-recommended
cancer screening at more than 30 healthcare institutions in
North America. In addition, GRAIL
has completed the third and final round of study visits for the
NHS-Galleri trial, 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 U.S. 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," said Bob Ragusa, Chief
Executive Officer at GRAIL. "Both studies were designed to enroll a
diverse participant population, representative of socio-economic,
ethnicity, gender and age differences, and we are proud of the
diversity of the study populations. 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 with a modular submission
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."
About the PATHFINDER 2 Study
(NCT05155605)
PATHFINDER 2 is a prospective,
multi-center, interventional study evaluating the safety and
performance of Galleri in a population of individuals aged 50 years
and older who are eligible for guideline-recommended cancer
screening in the United States.
PATHFINDER 2 is being conducted pursuant to an FDA-approved
investigational device exemption (IDE) application and began
enrolling in December 2021. The
primary objectives of the study are 1) 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, and 2) to 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. Participants who receive a cancer signal detected result
undergo additional diagnostic testing based on the predicted CSO to
determine if a cancer is present. Secondary objectives include
utilization of guideline-recommended cancer screening procedures
after use of the MCED test, and participant reported outcomes (PRO)
over several time points, including an assessment of participants'
anxiety and satisfaction with the MCED test. Timepoints for
collection will include baseline measurement prior to testing,
post-results, and post-diagnostic resolution for positive test
results.
The PATHFINDER 2 study is being conducted with leading
healthcare institutions across the United
States, including Cleveland Clinic, Duke University Health System, Flushing Hospital
Medical Center, Henry Ford Health System, Hoag, Inova, Jamaica
Hospital Medical Center, Kelsey-Seybold Clinic, Mayo Clinic,
Morehouse School of Medicine, Ochsner
Health, Oregon Health & Science University, Sarah Cannon, Sutter Health, University of Oklahoma, University of Pittsburgh, Virginia Commonwealth University, Weill Cornell
Medicine, and others.
About the NHS-Galleri Trial (NCT05611632)
In 2020, NHS
England selected GRAIL to assist with the United Kingdom's ambitions for early cancer
detection and to assess Galleri for potential population screening
on a national scale. In 2021, we initiated the NHS-Galleri trial, a
fully enrolled prospective randomized controlled clinical utility
trial of over 140,000 participants between the ages of 50 and 77 at
the time of enrollment, to evaluate the implementation of Galleri
alongside the existing NHS standard of care screenings. The primary
objective of the trial is to assess whether implementation of
Galleri can reduce the incidence of late-stage cancers through
early cancer detection. The trial aimed to enroll a representative
population sample to promote health equity and was fully enrolled
in just over 10 months.
The trial is designed for participants to provide three blood
draws over a two-year period, with the first draw taken at
enrollment. As a randomized controlled trial, half of the trial
participants have received the Galleri test, and half have had
their blood sample stored for future analysis. Any participant in
the interventional arm with a cancer signal detected result has
been referred for further diagnostic workup within the NHS. All
other participants and their physicians remain blinded as to which
arm of the study they are in. The NHS-Galleri trial design
was published in Cancers in 2022.
Collaborators include Queen Mary University of London, King's College London Cancer
Prevention Trials Unit, and NHS England.
About GRAIL, Inc.
GRAIL, Inc. is a healthcare
company whose mission is to detect cancer early, when it can be
cured. GRAIL is focused on alleviating the global burden of cancer
by using the power of next-generation sequencing, population-scale
clinical studies, and state-of-the-art machine learning, software,
and automation to detect and identify multiple deadly cancer types
in earlier stages. GRAIL's targeted methylation-based platform can
support the continuum of care for screening and precision oncology,
including multi-cancer early detection in symptomatic patients,
risk stratification, minimal residual disease detection, biomarker
subtyping, treatment and recurrence monitoring. GRAIL is
headquartered in Menlo Park, CA
with locations in Washington,
D.C., North Carolina, and
the United Kingdom.
For more information, visit grail.com.
About Galleri®
The Galleri multi-cancer early
detection test is a proactive tool in finding cancer early. With a
simple blood draw, the Galleri test can identify DNA shed by cancer
cells (unique "fingerprints") to help screen for some of the
deadliest cancers that don't have recommended screening today, such
as pancreatic, esophageal, ovarian, liver, and others.* The Galleri
test can be used to screen for cancer before a person becomes
symptomatic, when cancer may be more easily treated and potentially
curable. The Galleri test can indicate the origin of the cancer,
giving healthcare providers a roadmap of where to explore further.
The Galleri test requires a prescription from a licensed healthcare
provider and should be used in addition to recommended cancer
screenings such as mammography, colonoscopy, prostate-specific
antigen (PSA) test, or cervical cancer screening. It 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.
For more information about Galleri, visit galleri.com
* Sensitivity in study participants with – Pancreas cancer:
83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III,
95.9% stage IV). Esophagus cancer 85.0% overall (12.5% stage I,
64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer:
83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III,
94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage
I, 70.0% stage II, 100% stage III, 100% stage IV).
Important Galleri Safety Information
The Galleri test
is recommended for use in adults with an elevated risk for cancer,
such as those aged 50 or older. The Galleri test does not detect
all cancers and should be used in addition to routine cancer
screening tests recommended by a healthcare provider. Galleri is
intended to detect cancer signals and predict where in the body the
cancer signal is located. Use of Galleri is not recommended in
individuals who are pregnant, 21 years old or younger, or
undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the
context of medical history, clinical signs and symptoms. A test
result of Cancer Signal Not Detected does not rule out cancer. A
test result of Cancer Signal Detected requires confirmatory
diagnostic evaluation by medically established procedures (e.g.,
imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean
that cancer is not present or testing was insufficient to detect
cancer, including due to the cancer being located in a different
part of the body. False-positive (a cancer signal detected when
cancer is not present) and false-negative (a cancer signal not
detected when cancer is present) test results do occur. Rx
only.
Laboratory/Test Information
The GRAIL clinical
laboratory is certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) and accredited by the College of American
Pathologists. The Galleri test was developed, and its performance
characteristics were determined by GRAIL. The Galleri test has not
been cleared or approved by the U.S. Food and Drug Administration.
The GRAIL clinical laboratory is regulated under CLIA to perform
high-complexity testing. The Galleri test is intended for clinical
purposes.
Forward Looking Statements
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cases, you can identify these statements by forward-looking words
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"estimate," "expect," "intend," "may," "might," "plan,"
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and projections of generation of clinical data, use of data in our
future regulatory filings, timing of data readouts, or other
statements regarding our clinical studies and regulatory
compliance, and statements relating to our future performance,
future tests or products, technology, potential market opportunity,
anticipated growth strategies, and anticipated trends in our
business and our spin-off from Illumina.
These statements are only predictions based on our current
expectations and projections about future events and trends. There
are important factors that could cause our actual results, level of
activity, performance, or achievements to differ materially and
adversely from those expressed or implied by the forward-looking
statements, including those factors discussed under the section
entitled "Risk Factors" in our Registration Statement on Form 10
filed on June 3, 2024 (the "Form
10"), as may be further amended. Moreover, we operate in a dynamic
and rapidly changing environment. New risks emerge from time to
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nor can we assess the impact of all factors on our business or the
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SOURCE GRAIL, Inc.
