The ongoing real-world Prospective Clinicogenomic (PCG) Study compares the clinical actionability of both tissue- and blood-based comprehensive genomic profiling to limited tissue testing in this patient population
Cambridge, Mass. & New York, NY.,
Foundation Medicine, Inc., Flatiron Health, and Genentech, members of the Roche Group, in partnership with a network of community oncology practices, today announced new research in the Journal of Thoracic Oncology Clinical and Research Reports on tumor profiling results from the ongoing, multicenter Prospective Clinicogenomic (PCG) Study (NCT04180176). In this investigation, researchers compared the ability of FoundationOne®CDx and FoundationOne®Liquid CDx comprehensive genomic profiling (CGP) to limited tissue testing in detecting actionable, guideline-recommended biomarkers for targeted treatment planning in patients with advanced non-squamous non-small cell lung cancer (aNSCLC).
Despite continued adoption of CGP, most patients with advanced cancer still receive limited biomarker testing. The tumor profiling data from a diverse group of 515 aNSCLC patients in the PCG study demonstrates the superiority of both tissue- and blood-based CGP over more limited tissue testing in detecting actionable biomarkers. Additionally, the findings reinforce the value of blood-based CGP as a compelling and convenient complement to tissue-based CGP, especially when an adequate tissue sample is not immediately available.
Nine genes recommended for testing by clinical guidelines were included in the analysis: EGFR, KRAS, ALK, ROS1, RET, BRAF, MET exon 14, NTRK, as well as emerging biomarkers ERBB2 mutations and MET amplification. At study enrollment, patients with non-squamous aNSCLC received Foundation Medicine’s liquid biopsy CGP testing, and a subset also received Foundation Medicine tissue testing. Results demonstrate that tissue-based FoundationOne®CDx and blood-based FoundationOne®Liquid CDx both provided superior biomarker detection over more limited tissue testing of up to 5 biomarkers. In particular, Foundation Medicine’s liquid biopsy test detected guideline-recommended biomarkers in 48 additional patients who received single biomarker or hotspot testing.
“Precision oncology is transforming the way patients with cancer are treated, and there has been an explosion of targeted therapy options in lung cancer specifically,” said Foundation Medicine’s Chief Medical Officer, Dr. Mia Levy. “With the amount of diverse diagnostic tools now available to physicians, a key clinical question is how to piece these diagnostics together to optimally identify precision treatment options for patients with advanced cancer. Results from this research reinforce the unique benefits, and complementary value of both tissue- and blood-based CGP tests, depending on the patient’s tissue availability, health status and tumor type.”
Results from this research reinforce that, in certain patient cases where an adequate tissue sample is immediately available, tissue CGP offers the most reliable detection of guideline-recommended biomarkers. In cases where tissue is not immediately available, blood-based CGP can be used for expeditious CGP testing, though reflex tissue testing may be beneficial if blood-based CGP does not detect an actionable alteration to inform therapy selection. An important reason for this distinction is that liquid biopsy sensitivity is dependent upon the amount of tumor shed into the blood stream, called circulating tumor DNA (ctDNA). When ctDNA shed for a patient is low, a blood-based test may not be able to detect the ctDNA in the blood and tissue testing could yield additional insights.
“This initial analysis of the PCG Study data provides meaningful insights to help oncologists select the appropriate molecular diagnostic platform for their patients with lung cancer,” said Dr. Neal Meropol, Vice President, Research Oncology and Scientific and Clinical Lead, Clinical Research, Flatiron Health. “This research reinforces how advances in precision oncology are benefitting patients with advanced non-small cell lung cancer.”
The PCG Study, funded and sponsored by Genentech, pilots the use of a technology-enabled prospective data collection platform to facilitate, streamline and simplify the execution of clinical trials for patients living with advanced lung cancer, and secondarily aims to better understand how genomic changes in a patient’s tumor may predict response or impact resistance to treatment. A complete report of the PCG Study will be forthcoming to more fully describe the genomics of the pre-treatment and on-treatment comprehensive genomic profiling and its relationship to patient outcomes.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
About FoundationOne®CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.
About FoundationOne®Liquid CDx
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About Flatiron Health
Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.
