On August 8, 2022 Foundation Medicine, Inc., Flatiron Health, and Genentech, members of the Roche Group, in partnership with a network of community oncology practices, reported 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) (Press release, Foundation Medicine, AUG 8, 2022, View Source [SID1234617815]). In this investigation, researchers compared the ability of FoundationOneCDx and FoundationOneLiquid 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).
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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 FoundationOneCDx and blood-based FoundationOneLiquid 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.