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Advanced Solid Tumor Patients Deserve a Blood-First Paradigm

August 24th, 2021

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

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Not all oncology patients with actionable biomarkers are being identified, subjecting these patients to suboptimal treatment. But scientific advances have transformed the diagnostic landscape; when oncologists initiate comprehensive genomic profiling (CGP) of solid tumors by leading with liquid biopsy, they identify a greater number of biomarker-positive patients1,2 who can then benefit from the latest targeted treatments.1,3,4

Although tissue biopsies are a valuable diagnostic tool, the process is protracted and cumbersome. When the care team relies solely on tissue results, life-extending treatment may be delayed as the patient’s disease progresses and their prognosis worsens.5-7 This creates a sense of urgency, and oncologists often begin treatment without the critical insight CGP can provide, proceeding post-haste with chemotherapy, immunotherapy, or a combination of both in patients who may not benefit from these therapies. Not only does speed provide patients with a measure of stress relief, but clinical studies also confirm that biomarker-positive patients experience greater progression-free survival and overall response rates with targeted therapy.8-14

The benefits of testing decline dramatically if results arrive too late to influence outcomes. Now that the FDA has approved Guardant360® CDx liquid biopsy, patients have ready access to this optimal method of CGP. The results arrive quickly, so that physicians can make fast and well-informed treatment decisions.15

Compelling Data Supports a New Standard of Care

In the multi-center Noninvasive versus Invasive Lung Evaluation (NILE) study, Guardant360 liquid biopsy outperformed tissue testing by identifying 20% more patients with guideline-recommended biomarkers that can be targeted by FDA approved therapies.1

20% more patients with biomarkers detected using Guardant360® first.

Source: Leighl et.al. Clin Cancer Research 2019

In another large prospective study, almost twice as many advanced non-small cell lung cancer (NSCLC) patients with actionable alterations were identified using both liquid and tissue biopsies (n=82) vs tissue alone (n=47).2  These results are reinforced by more than 200 peer-reviewed publications demonstrating the efficacy of liquid biopsy.16

Guardant360 CDx is the first comprehensive liquid biopsy approved by the FDA17 and administered through mobile or in-office phlebotomy to facilitate guideline-recommended genomic results in just 7 days. The assay uses proprietary next-generation sequencing technology to simultaneously detect mutations in a broad panel of clinically-relevant solid tumor genes.18

Blood-First: A Clear Call to Action

With so many emerging targeted therapies, a blood-first paradigm is critical and necessary for patients with NSCLC and all solid tumors.19 Evidence shows that liquid biopsy is likely to detect more biomarkers, leading to treatment for a greater number of patients, and it does so rapidly, when time is of the essence.1-3

As oncologists and cancer patients face the urgency and complexity of treatment, liquid biopsy provides rapid turnaround and ease of use for complete genotyping. Guardant360 CDx guides precision treatment decisions for NSCLC and the full spectrum of advanced solid tumors.20

For patients with NSCLC and other solid tumors, leading with Guardant360 CDx leads to more successful outcomes—what every oncologist strives for and every patient deserves.20

References

  1. 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 CancerRes. 2019; 25(15)4691-4700.
  2. 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.
  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. Nesline MK, DePietro P, Dy GK, et al. Oncologist uptake of comprehensive genomic profile guided targeted therapy. Oncotarget. 2019 Jul 23; 10(45):4616-4629.
  5. Hanna T, King WD, Thibodeau S, Jalink M, Paulin GA, et al. Mortality due to cancer treatment delay: systematic review and meta-analysis BMJ 2020; 371:m4087
  6. Shen SMH, Hung YC, Kung, PT, Yang WH, Wang YH, Tsa WC. Factors involved in the delay of treatment initiation for cervical cancer patients, Medicine. 2016 August. Volume 95 – Issue 33 – p e4568
  7. Mohammed N, Kestin LL, Grills IS, Battu M, Fitch DL, Wong CY, Margolis JH, Chmielewski GW, Welsh RJ. Rapid disease progression with delay in treatment of non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1; 79(2):466-72.
  8. 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.
  9. 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.
  10. Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK susion variant on the efficacy of alectinib in untreated ALK-positive advanced non–small cell lung cancer in the global phase III ALEX Study. J Thorac Oncol. 2019; 14(7):1233-1243.
  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.
  14. Venkatesan S, Charles Swanton C. Tumor Evolutionary Principles: How Intratumor Heterogeneity Influences Cancer Treatment and Outcome. American Society of Clinical Oncology Educational Book 2016; 36, e141-e149.
  15. Saarenheimo J, Eigeliene N, Andersen H, Tiirola M, Jekunen A. The Value of Liquid Biopsies for Guiding Therapy Decisions in Non-small Cell Lung Cancer. Front Oncol. 2019 Mar 5;9:129.
  16. Guardant. Featured publications. n.d. Retrieved March 16, 2021, from: /publications/.
  17. 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.
  18. Guardant. Backgrounder: Guardant360® CDx now FDA approved. N.d. Retrieved March 17, 2021, from: https://guardanthealth.com/wp-content/uploads/Backgrounder-for-Media-Guardant360-CDx.pdf
  19. Pennell NA, Arcila ME, Gandara DR, and West H. Biomarker testing for patients with advanced non–small cell lung cancer: real-world issues and tough choices. American Society of Clinical Oncology Educational Book. 2019: 39, 531-542.
  20. Lee MJ, Hueniken K, Kuehne N, et al. Cancer patient-reported preferences and knowledge for liquid biopsies and blood biomarkers at a comprehensive cancer center. Cancer Manag Res. 2020 Feb 13; 12:1163-1173.