GRAIL Announces Positive New Data with Multi-Cancer Early Detection Blood Test from CCGA Study
May 31, 2019
— Investigational Multi-Cancer Blood Test Detects Strong Signal for
12 Deadly Cancer Types When They are Still Localized, with 99 Percent
Specificity, and Identifies Tumor’s Tissue of Origin with High Accuracy
—
— Data Presented at 2019 ASCO Annual Meeting Support Feasibility of
GRAIL’s Multi-Cancer Approach —
— GRAIL Plans to Advance Development of Multi-Cancer Test Toward
Commercialization —
MENLO PARK, Calif.–(BUSINESS WIRE)–GRAIL, Inc., a healthcare company focused on the early detection of
cancer, today announced new data from the Circulating Cell-free Genome
Atlas (CCGA) study that demonstrates the ability of GRAIL’s technology
to detect cancer early with a single blood test. Data showed GRAIL’s
investigational multi-cancer blood test detected a strong signal for 12
deadly cancer types at early stages with a very high specificity of at
least 99 percent (or a false positive rate of one percent or less). In
addition, the test identified where the cancer originated in the body
(the tissue of origin) with high accuracy.
Detection rates (sensitivity) for the 12 deadly cancer types ranged from
59 to 86 percent at early stages (stages I-III). A combined analysis of
this group of cancers showed robust detection at early stages (34
percent, 77 percent, and 84 percent at stages I, II, and III,
respectively). In addition, a tissue of origin result was provided for
94 percent of all cancers detected and, of these, the test correctly
identified the tissue of origin in 90 percent of cases.
The 12 pre-specified cancer types included anorectal, colorectal,
esophageal, gastric, head and neck, hormone receptor negative breast,
liver, lung, ovarian, and pancreatic cancers, as well as multiple
myeloma and lymphoid neoplasms. Together, these cancer types account for
approximately 63 percent of all cancer deaths in the United States.
These data will be presented in a poster tomorrow, Saturday, June 1 at
the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting by
Minetta Liu, MD, Research Chair and Professor, Department of Oncology,
Mayo Clinic (Abstract 3049).
“These exciting results suggest we can achieve what we believe are the
requirements for a cancer screening blood test, including detection of
multiple deadly cancer types at early stages in a single test, high
accuracy in determining where the cancer originated, and a very low
false positive rate,” said Jennifer Cook, Chief Executive Officer at
GRAIL. “Our improved methylation-based technology has the potential to
address gaps that exist with today’s screening options, which are
limited to a few cancer types and only screen for one cancer type at a
time. Based on these positive data, we plan to advance development of
our test toward commercialization.”
“These very promising data indicate that a highly specific blood test
for early cancer detection is approaching reality,” said Dr. Liu, who is
also an investigator on the CCGA study. “The exceptional accuracy in
determining the tissue of origin across all stages for those
malignancies with significant cancer-specific mortality suggests that,
if a cancer is detected, the test will inform where the tumor originated
in the majority of cases. This factor is critical to streamline the
clinical workup.”
“When we set out on this journey, we knew that to be successful, a
blood-based screening tool would need to detect the clinically important
cancers and not contribute to overdiagnosis of indolent cancers at the
earliest stages,” said Rick Klausner, MD, Former Director of the
National Cancer Institute, and Founder and Director of GRAIL. “Data
being presented at ASCO suggest GRAIL’s test preferentially detects the
most lethal cancers and can detect tumors when they are still localized
and amenable to successful treatment. The high detection rate of stage
II cancers at 77 percent in the group of 12 deadly cancers is
particularly compelling and supports the potential benefit of our
multi-cancer approach.”
Additional Results
In the second pre-planned case-control sub-study of CCGA, GRAIL’s
multi-cancer early detection blood test is being evaluated in
approximately 4,500 participants for its ability to detect cancer and
identify the tissue of origin when cancer is present. Data reported at
ASCO are based on an initial analysis of 2,301 participants from the
training phase of the sub-study, including 1,422 participants with more
than 20 cancer types across all stages and 879 participants without
diagnosed cancer. This sub-study is ongoing, and the company is planning
to present additional results at future medical conferences.
All results are reported at 99 percent specificity, which equates to a
false positive rate of one percent. The actual false positive rate may
be less than one percent, since cancer incidence rates suggest some of
the individuals enrolled in the non-cancer group may have had an
undiagnosed cancer at enrollment. Follow-up of participants in CCGA is
ongoing, and outcomes will be collected for five years.
The overall detection rate for more than 20 cancer types in the
sub-study across all stages was 55 percent (n=784/1,422; 95% confidence
interval: 52.5-57.7%). A tissue of origin result across more than 20
cancer types was provided for 94 percent of all cancers detected by
GRAIL’s test (n=735/784), and of these, the test correctly identified
the tissue of origin in 90 percent of cases (n=663/735).
The overall detection rate for the 12 pre-specified deadly cancer types
across all stages was 76 percent (n=671/882; 95% confidence interval:
73-79%). The tissue of origin accuracy for this group of cancers was
consistent regardless of stage ranging from 84 to 92 percent.
Additional results for the 12 pre-specified deadly cancer types are
detailed below.
|
Detection Rates (Sensitivity) at Early Stages (Stages I-III) |
|||
| Cancer Type (N) | Sensitivity | ||
| (95% CI) | |||
| Lung (151) | 59% | ||
| (51-67%) | |||
| Colorectal (72) | 74% | ||
| (62-83%) | |||
|
Hormone Receptor Negative Breast (67) |
64% | ||
|
|
(52-76%) | ||
|
Lymphoma☨ (60) |
70% | ||
| (57-81%) | |||
|
Pancreatic (41) |
78% | ||
| (62-89%) | |||
| Head and Neck (36) | 86% | ||
| (71-95%) | |||
| Multiple Myeloma (34) | 71% | ||
| (53-85%) | |||
|
Ovarian (30) |
67% | ||
| (47-83%) | |||
| Esophageal (25) | 76% | ||
| (55-91%) | |||
| Liver (25) | 68% | ||
| (46-85%) | |||
| Anorectal (14) | 79% | ||
| (49-95%) | |||
| Gastric (9) | 78% | ||
| (40-97%) | |||
|
☨Excludes leukemias, which are not staged |
|||
|
Detection Rates (Sensitivity) and Tissue of Origin Accuracy by |
||||||
| Stage | Sensitivity | Tissue of Origin Accuracy* | ||||
| (N) | (N) | |||||
| (95% CI) | ||||||
| Stage I | 34% |
84% |
||||
| (151) |
(44) |
|||||
| (27-43%) |
|
|||||
| Stage II | 77% |
91% |
||||
| (171) |
(124) |
|||||
| (70-83%) |
|
|||||
| Stage III | 84% |
92% |
||||
| (242) |
(192) |
|||||
| (79-89%) |
|
|||||
| Stage IV | 92% |
91% |
||||
| (281) |
(249) |
|||||
| (88-95%) |
|
|||||
|
☨Excludes leukemias, which are not staged |
||||||
|
*Performance in 94% of cases where a tissue of origin result |
||||||
|
Tissue of Origin Prediction Across All Stages (Stages I-IV) for |
|||
| Cancer Type | Correct Tissue of Origin | ||
| (Number of Predictions) | |||
| Lung (165) | 92% | ||
| Colorectal (87) | 97% | ||
| Breast (78) | 96% | ||
| Lymphoid Neoplasms (107) | 89% | ||
|
Pancreatic (68) |
79% | ||
| Head and Neck (53) |
|
81% | |
| Multiple Myeloma (23) | 96% | ||
|
Ovarian (25) |
96% | ||
| Upper Gastrointestinal |
89% |
||
| (Esophageal and Gastric combined) (44) |
|
||
| Liver (29) | 72% | ||
| Anorectal (3) | 67% | ||
|
*Performance in 94% of cases where a tissue of origin result |
|||
Poster Presentation Details
Posters will be available online at https://grail.com/science/publications/
at time of presentation.
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
*Includes data from
second CCGA sub-study
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 CCGA
The Circulating Cell-free Genome Atlas (CCGA) study is a prospective,
observational, longitudinal, case-control study that has completed
enrollment of approximately 15,000 participants with and without cancer
across 142 sites in the United States and Canada. CCGA is designed to
characterize the landscape of genomic cancer signals in the blood and to
discover, train, and validate GRAIL’s multi-cancer early detection blood
test through three pre-planned sub-studies.
About GRAIL’s Investigational Multi-Cancer Early Detection Test
GRAIL is developing a next-generation sequencing (NGS) blood test for
the early detection of multiple deadly cancer types. GRAIL’s high
efficiency methylation-based 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.
Contacts
GRAIL
Charlotte Arnold
650-255-1909
[email protected]