CHICAGO–(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. In a sub-analysis of the first pre-planned sub-study of CCGA, blood samples from 127 participants with lung cancer were evaluated with three prototype genome-sequencing assays. Detection rates (sensitivity at 98 percent specificity) across the assays ranged from 38 to 51 percent in participants with early-stage lung cancer (stages I-IIIA), and 87 to 89 percent in those with later stages (stages IIIB-IV).
These data will be presented today in a press briefing at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, and also as an oral presentation on Monday, June 4, 2018 by Geoffrey Oxnard, MD, Associate Professor of Medicine at Dana-Farber Cancer Institute and Harvard Medical School.
“Lung cancer is the single greatest cause of cancer death globally and is typically diagnosed at late stages when, despite recent treatment breakthroughs, survival is often measured in months,” said Dr. Oxnard. “These initial data from CCGA are exciting because they suggest it is possible to detect lung cancer through DNA signals in the blood at earlier stages when survival rates may be higher.”
“We are encouraged by these initial results and believe a highly specific blood test for lung cancer could help improve early detection rates for this deadly disease,” said Anne-Renee Hartman, MD, Vice President of Clinical Development at GRAIL. “Lung cancer will be an important focus in our ongoing clinical development program for the early detection of multiple cancer types.”
More than 154,000 people are expected to die from lung cancer in the United States in 20181 and approximately 1.7 million globally.2The five-year survival rate for lung cancer overall is 18 percent. The five-year survival rate for early-stage lung cancer is 56 percent; however, only 16 percent of lung cancers are diagnosed at this early stage.1
Additional Results
In this pre-planned sub-study of CCGA, three prototype genome-sequencing assays were evaluated as potential methods for a blood-based test for early cancer detection. In the first training phase of the sub-study, blood samples from 1,627 participants with and without cancer were sequenced. Twenty different cancer types across all stages were included in the sub-study.
For the lung cancer sub-analysis, blood samples from 127 participants with lung cancer were analyzed.
The prototype sequencing assays included:
- Targeted sequencing of paired cell-free DNA (cfDNA) and white blood cells to detect mutations such as a single nucleotide variants and small insertions and/or deletions;
- Whole-genome sequencing of paired cfDNA and white blood cells to detect somatic copy number changes; and
- Whole-genome bisulfite sequencing of cfDNA to detect abnormal cfDNA methylation patterns.
Detection Rates (Sensitivity) for Lung Cancer at 98 Percent Specificity
| Stages I-IIIA n=63* (95% Confidence Interval) |
Stages IIIB- IV n=54* (95% Confidence Interval) |
|
| Whole-Genome Bisulfite Assay | 41% (29-54%) |
89% (77-96%) |
| Whole-Genome Assay | 38% (26-51%) |
87% (75-95%) |
| Targeted Assay | 51% (38-64%) |
89% (77-96%) |
*For this analysis, 117 participants had evaluable data from all three assays and had informative staging
Detection rates ranged from 59 to 92 percent across the assays and across all stages in people with adenocarcinoma, squamous cell and small cell lung cancers.
Detection Rates (Sensitivities) for Lung Cancer Subtypes (Stages I-IV) at 98 Percent Specificity
| Adenocarcinoma n=58 (95% Confidence Interval) |
Squamous cell n=28 (95% Confidence Interval) |
Small cell n=13 (95% Confidence Interval) |
|
| Whole-Genome Bisulfite Assay | 62% (48-75%) |
61% (41-79%) |
85% (55-98%) |
| Whole-Genome Assay | 59% (45-71%) |
61% (41-79%) |
77% (46-95%) |
| Targeted Assay | 60% (47-73%) |
79% (59-92%) |
92% (64->99%) |
Presentation Details
Abstract LBA8501
Genome-wide sequencing for early stage lung cancer detection from plasma cell-free DNA (cfDNA): The Circulating Cell-free Genome Atlas (CCGA) study
ASCO Press Program: Saturday, June 2, 2018: 8:00 – 9:00am CDT, Room E353b
Oral Presentation: Monday, June 4, 2018: 8:12 – 8:24am CDT, Hall B1
About CCGA
CCGA is a prospective, observational, longitudinal study designed to characterize the landscape of cell-free nucleic acid (cfNA) profiles in people with and without cancer. The planned enrollment for the study is more than 15,000 participants across 142 sites in the United States and Canada. Approximately 70 percent of participants will have cancer at the time of enrollment (newly diagnosed, have not yet received treatment) and 30 percent will not have a known cancer diagnosis. The groups are demographically similar and representative of a real-world population. The group of participants without cancer includes individuals with conditions that are known to increase cfNA signal, such as inflammatory or autoimmune diseases. Planned follow-up for all participants is at least five years to collect clinical outcomes.
About GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity 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 and commercialize pioneering products for the early detection of cancer. The company is located in Menlo Park, California and Hong Kong. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
1 American Cancer Society Cancer Facts and Figures 2018
2 World Health Organization http://www.who.int/news-room/fact-sheets/detail/cancer