A New Standard of Care

March 14th, 2021

Rebecca Nagy, Vice President Medical Affairs, Guardant Health, Professor Clinical Internal Medicine, Licensed Genetic Counselor


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Targeted cancer therapies are prolonging patient survival times and improving quality of life,1 outcomes which are facilitated by tumor mutation profiling.2 Because cancer genomes are complex, comprehensive genomic profiling (CGP) offers the greatest insight into optimal treatment. In a 2020 study published in Cancers (Basel)3, “CGP identified at least one potentially clinically actionable genomic alteration in 95% of all patients tested”.

Regardless of the percent, it is critical that patients are both tested and are then treated based on CGP results. The easiest, most expedient way to ensure patients receive tumor genotyping is with plasma-based testing. Because precision medicine continues to advance oncology, liquid biopsy is quickly becoming a new standard of care.4

Guardant360 CDx, the first comprehensive liquid biopsy approved by the FDA,5 provides guideline-recommended genomic results in 7 days. The assay uses proprietary next-generation sequencing technology to simultaneously detect mutations in a broad panel of clinically-relevant solid tumor genes.

Liquid Biopsy: Better Insight, Better Care, Better Outcomes

Leading with liquid biopsy for comprehensive genomic profiling accelerates decision making and finds more patients altogether.

20% more patients with biomarkers detected using Guardant360 first

Source: Leighl et.al. Clin Cancer Research 2019

In the NILE Study, 282 patients with untreated nonsquamous NSCLC underwent SOC tissue genotyping and provided a pre-treatment blood sample for analysis of cell-free DNA (cfDNA). Compared with tissue genotyping, a higher percentage of liquid biopsies identified one of 8 key guideline-recommended biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET, METex14, and ERBB2) (21.3% vs 27.3%; P < .0001).7

When cfDNA was used in addition to tissue, the detection of guideline-recommended biomarkers improved by 48%, rising from 60 to 89 patients, including those with negative tissue testing results (7), those not tested (16), and those whose samples were insufficient for tissue-based testing (6).7

FDA-approved Guardant360 CDx is the sole test to utilize the proprietary digital sequencing and ctDNA capture technology that facilitates high sensitivity, specificity, and substantially faster turnaround time than tissue alone.5

Comprehensive Liquid Biopsy as the Standard of Care

The ability to identify tumor mutations in such a minimally-invasive, swift, accurate, cost-effective, and repeatable way has a significantly favorable impact on both patients and providers. Adopting liquid biopsy as a standard of care is highly appealing to oncologists for all the rational reasons—ease of use, lower cost, and rapid results—but perhaps most convincing for healthcare providers is the superiority in detection.6 Finding more patients with oncogenic drivers ultimately leads to improved patient care and more favorable outcomes.8-10, 11-13

references

  1. Yuan, M, Huang, LL, Chen, JH, et al. The emerging treatment landscape of targeted therapy in non-small-cell lung cancer. Sig Transduct Target Ther. 2019; 4, 61.
  2. Nalley C. Genomic profiling Identifies patients most likely to respond to immunotherapy. Oncology Times. 2017; 39(20):29,31.
  3. Singh AP, Shum E, Rajdev L, et al. Impact and diagnostic gaps of comprehensive genomic profiling in real-world clinical practice. Cancers (Basel). 2020 May 4; 12(5):1156.
  4. Panabieres C. The future of liquid biopsy. Nature. 2020; 579,S9
  5. U.S. Food & Drug Administration. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. Fda.gov. 2020 Aug 7; Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test.
  6. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non–small cell lung cancer. JAMA Oncol. 2019; 5(2):173-180.
  7. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. Clin Cancer Res. 2019; 25(15)4691-4700.
  8. Shaw AT, Riely GJ, Bang Y-J, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann. Oncol. 2019; 30(7):1121-1126.
  9. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Ann. Oncol. 2019; 30(5):v851-v934.
  10. Garon EB, Hellmann MD, Costa EC, et al. Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001. J Clin Oncol. 2019; 37(28):2518-2527.
  11. Novartis. Efficacy of Tafinlar-Mekinist in metastatic non-small cell lung cancer with BRAF V600E. n.d. https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/ Accessed online Jan. 10, 2020.
  12. Gadgeel SM, Garassino MC, Esteban E, et al. KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC. J Clin Oncol. 2019; 37(suppl; abstr 9013).
  13. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006; 14;355(24):2542-2550.