MENLO
PARK, Calif., Nov. 18,
2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a
healthcare company whose mission is to detect cancer early when it
can be cured, today announced that the first patient has been
tested for eligibility with the investigational GRAIL
Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global
TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens
in patients with Stage I adenocarcinoma NSCLC. The study is
sponsored by AstraZeneca (LSE/STO/Nasdaq:AZN) in collaboration with
Daiichi Sankyo (TSE: 4568).
The study, which is being conducted under an FDA-approved
Investigational Device Exemption application, held by GRAIL,
leverages GRAIL's targeted methylation platform to detect ctDNA.
With GRAIL's blood-only approach, tissue analysis and bespoke panel
development are not required, enabling simple integration into
pharmaceutical clinical trial workflows. In TROPION-Lung12,
patients will be screened with the GRAIL assay prior to surgery to
inform eligibility for post-surgery randomization to an adjuvant
treatment regimen (NCT06564844). Assay performance was previously
reported in the Journal of Thoracic Oncology and presented
at the 2023 North America Conference on Lung Cancer.
"We're excited to continue our strategic collaboration with
AstraZeneca with the use of our novel assay in the TROPION-Lung12
study. We hope this study will further demonstrate the potential of
GRAIL's Methylation Platform to enhance patient selection for
cancer treatment," said Harpal
Kumar, President, International Business & Biopharma, at
GRAIL. "GRAIL's ctDNA detection approach, which does not require
tumor tissue, has the potential to offer oncologists a rapid,
accessible method to help refine patients' diagnostic and
prognostic profiles for better guided cancer therapy. This is among
the first times a ctDNA assay has been used in a clinical trial of
early-stage lung cancer patients to identify those most likely to
benefit from further treatment. As such, we hope this approach
could provide substantial additional benefit for patients diagnosed
with Stage 1 lung cancer."
"In TROPION-Lung12, screening for ctDNA is intended to identify
the patients at an increased risk of disease recurrence after
surgery and thus most likely to benefit from adjuvant therapy,"
said Cristian Massacesi, MD, Chief
Medical Officer and Oncology Chief Development Officer,
AstraZeneca. "The novel strategy we are deploying in this trial
illustrates our commitment to both detect cancer earlier and use
those early insights to enable more personalized treatment
decisions for the benefit of patients."
In 2022, GRAIL announced a broad strategic collaboration with
AstraZeneca to develop and commercialize companion diagnostic (CDx)
assays for use with AstraZeneca's therapies. GRAIL is committed to
leveraging its blood-based methylation testing for patient care by
developing fit-for-purpose diagnostics to enable precision oncology
strategies with biopharma partners.
About GRAIL
GRAIL 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.
Laboratory/Test Information
GRAIL's clinical
laboratory is certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) and accredited by the College of American
Pathologists. GRAIL's clinical laboratory is regulated under CLIA
to perform high-complexity testing. GRAIL's current product
offerings have not been cleared or approved by the U.S. Food and
Drug Administration.
Forward Looking Statements
This press release contains
forward-looking statements. In some cases, you can identify these
statements by forward-looking words such as "aim," "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "potential," "predict," "should," "would,"
or "will," the negative of these terms, and other comparable
terminology. These forward-looking statements, which are subject to
risks, uncertainties, and assumptions about us, may include
statements about benefits for patients with lung cancer,
expectations and projections of future tests or products,
technology, clinical studies, regulatory compliance, future
investment and strategy and anticipated trends in our business.
These statements are only predictions based on GRAIL's 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 GRAIL's most recent Quarterly Report on
Form 10-Q filed with the SEC. Moreover, GRAIL operates in a dynamic
and rapidly changing environment. New risks emerge from time to
time. It is not possible for GRAIL's management to predict all
risks, nor can they assess the impact of all factors on GRAIL's
business or the extent to which any factor, or combination of
factors, may cause actual results, level of activity, performance,
or achievements to differ materially and adversely from those
contained in any forward-looking statements GRAIL may make.
Forward-looking statements relate to the future and,
accordingly, are subject to inherent uncertainties, risks, and
changes in circumstances that are difficult to predict and many of
which are outside of GRAIL's control. Although GRAIL believes the
expectations and projections expressed or implied by the
forward-looking statements are reasonable, GRAIL cannot guarantee
future results, level of activity, performance, or achievements.
GRAIL's actual results and financial condition may differ
materially from those indicated in the forward-looking statements.
Except to the extent required by law, GRAIL undertakes no
obligation to update any of these forward-looking statements after
the date of this press release to conform its prior statements to
actual results or revised expectations or to reflect new
information or the occurrence of unanticipated events.
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SOURCE GRAIL, Inc.