— Methylation Technology Identifies Tumor Tissue of Origin of
Multiple Cancer Types with High Accuracy —
— Initial Survival Analysis of CCGA Participants Adds to Evidence
Suggesting Technology Preferentially Detects More Aggressive Cancers —
MENLO PARK, Calif.–(BUSINESS WIRE)–GRAIL, Inc., a healthcare company focused on the early detection of
cancer, today announced that new findings from its Circulating Cell-free
Genome Atlas (CCGA) study will be presented in four poster presentations
at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting
taking place May 31 – June 4 in Chicago.
Previously reported data from the first sub-study of CCGA showed GRAIL’s
prototype technology could detect the presence of multiple deadly cancer
types with a low rate of false positive results (high specificity).1
An abstract posted online today ahead of the 2019 ASCO Annual Meeting
reports data from an analysis from the first CCGA sub-study showing
GRAIL’s prototype methylation technology detected the tumor tissue of
origin (where the cancer originated in the body) with high accuracy
(Abstract 3049). This analysis evaluated blood samples from 166
participants who had a cancer diagnosis at the time of enrollment, and
whose cancer was detected using the methylation technology. Results
showed the technology correctly identified the tumor’s tissue of origin
in 87 percent of the blood samples evaluated (n=144/166), including 96
percent of breast cancer cases (n=22/23); 88 percent of lung cancer
cases (n=29/33); 90 percent of liver cancer cases (n=9/10); and 100
percent of pancreatic cancer cases (n=17/17).
GRAIL has since selected methylation as its preferred approach and is
now evaluating its refined methylation blood test in the second
pre-planned sub-study of CCGA. Initial data from the second CCGA
sub-study will be presented at ASCO, reporting the ability of GRAIL’s
methylation test to detect multiple cancer types and identify the tumor
tissue of origin.
“Identifying the tumor tissue of origin will be a critical feature of
our multi-cancer early detection test to enable doctors to appropriately
direct next steps for diagnosis and care,” said Alexander Aravanis, MD,
PhD, Chief Scientific Officer at GRAIL. “Our unique test is designed to
combine our methylation technology, a proprietary database of
methylation signatures, and GRAIL’s machine-learning algorithms to both
detect the presence of cancer and determine where in the body the cancer
originated. We look forward to presenting initial results from our next
CCGA sub-study at ASCO.”
Survival Data (Abstract 1545)
Data presented last year showed GRAIL’s technology detected the
strongest signals for the deadliest cancer types, while signal for
indolent cancer types was low.1 A new analysis evaluated
survival of 1,289 CCGA participants in the first CCGA sub-study with at
least one year of clinical follow-up. Results showed people in the study
whose cancer was detected by the methylation technology were three times
more likely to die from their cancer compared to participants whose
cancer was not detected by the technology, independent of clinical stage
(HR=3.0, p<0.001). By comparison, participants with stage IV cancers
were three times more likely to die than those with stage I-III cancers
(HR=3.3, p<0.001). These data suggest detection with GRAIL’s methylation
technology could have a similar ability to predict survival as clinical
stage.
“Overdiagnosis of some cancer types that are slow-growing can be a
concern with current screening tests,” said Geoffrey Oxnard, MD,
Associate Professor of Medicine at Dana-Farber Cancer Institute and
Harvard Medical School. “These initial follow-up data are encouraging
and add to the evidence from the CCGA study suggesting this blood test
may detect the types of cancers more in need of immediate treatment,
rather than contributing to the overdiagnosis of indolent cancers.”
Follow-up of participants in CCGA is ongoing and outcomes will be
collected for five years. These long-term data are important for
determining the potential clinical impact of detecting deadly cancers in
the blood before a person presents with symptoms.
Details for Posters Featuring GRAIL’s Data at ASCO
Abstract 3049
Minetta C. Liu, et al. Genome-wide
cell-free DNA (cfDNA) methylation signatures and effect on tissue of
origin (TOO) performance
Poster Session: June 1, 2019:
8:00-11:00AM CDT, Hall A, Poster Board #41
Abstract 3103
Darya Filippova, et al. The Circulating
Cell-free Genome Atlas (CCGA) study: Size selection of cell-free DNA
(cfDNA) fragments
Poster Session: June 1, 2019: 8:00-11:00AM
CDT, Hall A, Poster Board #95
Abstract 5574
Allen Cohn, et al. The Circulating
Cell-free Genome Atlas (CCGA) study: Follow-up (F/U) on non-cancer
participants with cancer-like cell-free DNA signals
Poster
Session: June 1, 2019: 1:15-4:15PM CDT, Hall A, Poster Board #397
Abstract 1545
Geoffrey R. Oxnard, et al. Prognostic
significance of blood-based cancer detection in plasma cell-free DNA
(cfDNA): Evaluating risk of overdiagnosis
Poster Session: June
3, 2019: 1:15-4:15PM CDT, Hall A, Poster Board #39
About the Circulating Cell-free Genome Atlas (CCGA) Study
The CCGA study is a prospective, observational, longitudinal study that
has completed enrollment of approximately 15,000 people with and without
cancer across 142 sites in the United States and Canada. GRAIL is
conducting three pre-planned sub-studies within CCGA to discover, train,
and validate its multi-cancer early detection test.
About GRAIL’s Methylation Technology
GRAIL is developing a next-generation sequencing (NGS) blood test for
the early detection of multiple deadly cancer types. GRAIL’s high
efficiency methylation technology preferentially targets the most
informative regions of the genome, and is designed to use its
proprietary database and machine-learning algorithms to both detect the
presence of cancer and identify the tumor’s tissue of origin. GRAIL’s
sequencing database of cancer and non-cancer methylation signatures is
believed to be the largest of its kind, and covers approximately 30
million methylation sites across the genome. More than 20 cancer types
across stages are represented within the database.
DNA methylation is a natural process used by cells to regulate gene
expression. It is a chemical modification to DNA and a well-studied
epigenomic feature of the genome. In cancer, abnormal methylation
patterns and the resulting changes in gene expression can contribute to
tumor growth. For example, hypermethylation can cause tumor-suppressor
genes to be inactivated.
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 developing pioneering technology to detect and identify
multiple deadly cancer types early. The company is using the power of
next-generation sequencing, population-scale clinical studies, and
state-of-the-art computer science and data science to enhance the
scientific understanding of cancer biology, and to develop its
multi-cancer early detection blood test. GRAIL is located in Menlo Park,
California. It is supported by leading global investors and
pharmaceutical, technology, and healthcare companies. For more
information, please visit www.grail.com.
1 Klein EA et al., J Clin Oncol. 2018;36 (suppl; abstr
12021); https://grail.com/wp-content/uploads/2018/09/ASCO_2018_CCGA-Multi-Cancer_Klein_POS_Final.pdf
Contacts
GRAIL
Kelsey Grossman
925-683-5258
pr@grail.com