Head-to-Head Study Shows Guardant360 Liquid Biopsy Outperforms Tissue Biopsy for Comprehensive Genomic Profiling in Advanced Non-Small Cell Lung Cancer with Similar Outcomes

Guardant Health, Inc. (Nasdaq: GH). Despite guideline recommendations for comprehensive genomic profiling (CGP) of all patients with advanced non-small cell lung cancer (NSCLC), profiling remains suboptimal due to continued reliance on invasive tissue biopsies for testing. A new study published in JCO Precision Oncology confirms previously reported data showing that the Guardant360^® liquid biopsy is not only concordant to tissue genotyping, but detects significantly more informative alterations when used prior to tissue testing, and achieves similar treatment response rates and progression-free survival in patients with NSCLC. Publication link here.

The prospective study¹ (n=186) compares comprehensive genomic profiling using the Guardant360 liquid biopsy versus standard-of-care tissue genotyping for first-line treatment decisions in advanced NSCLC. Patients with advanced NSCLC received targeted therapies based on the actionable biomarkers identified. Compared to tissue biopsy genotyping at time of diagnoses, the Guardant360 liquid biopsy was not only concordant with tissue biopsy but detected 23.6 percent more informative mutations when used first and before tissue biopsy.

The study adds to the growing body of evidence^2-4 demonstrating that using a “blood-first approach” using the Guardant360 test for genomic biomarker detection can identify more actionable biomarkers than a “tissue-first approach”. Importantly, objective response rates and progression-free survival in biomarker-positive patients receiving targeted therapy was similar to previously reported registrational trials.

“Despite the ever-growing availability of life-changing targeted drugs for treating patients with advanced lung cancer, many continue to be treated with chemotherapy or immunotherapy because first-line treatments are made without conducting comprehensive genotyping first,” said the Principal Investigator of this study Dr. Rafael Rossell, Chief Medical Officer and President of the Dr. Rosell Oncology Institute. “This publication outlines further evidence that the Guardant Health liquid biopsy is very effective in uncovering actionable genomic alterations, overcomes the challenges of tissue biopsies, and helps clinicians more easily customize treatments to improve the prognosis and survival of their patients.”

Numerous clinical studies show that patients receiving targeted or personalized treatments have improved progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.^5-11 Various factors contribute to clinical adoption of personalized medicine lagging behind recommended medical guidelines, including insufficient tissue for biopsy, which is the case for as many as 30 percent of solid cancer patients.^12-14

“Once again, the data show that our blood-first approach using our Guardant360 liquid biopsy has the advantage of increasing the number of patients receiving potentially life-changing targeted treatments without compromising treatment efficacy,” said Helmy Eltoukhy, Guardant Health CEO. “Sadly, research indicates that approximately 80 percent of advanced lung cancer patients do not receive comprehensive genotyping before starting treatment. I hope that with the recent FDA approval of our Guardant360 CDx liquid biopsy test, more clinicians will feel confident making the shift to liquid biopsies so we can reverse the serious trend of undergenotyping that exists today.”

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360^®, Guardant360 CDx, and GuardantOMNI^® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019, in its Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020, respectively, and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

References

1. Palmero R, Taus A, Viteri S, et al. Biomarker Discovery and Outcomes for Comprehensive Cell-Free Circulating Tumor DNA Versus Standard-of-Care Tissue Testing in Advanced Non–Small-Cell Lung Cancer. JCO Precision Oncology. 2021;5: 93-102
2. 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. doi: 10.1158/1078-0432.CCR-19-0624.
3. 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. doi:10.1001/jamaoncol.2018.4305
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5. 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.
6. 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.
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12. Hagemann IS, Devarakonda S, Lockwood CM, et al. Clinical Next-Generation Sequencing in Patients with Non–Small Cell Lung Cancer. Cancer. 2015;121:631-639.
13. Parsons HA, Beaver JA, Cimino-Mathews A, et al. Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer. Cancer Res. 2017;23(2); 379–386.
14. Wyatt AW, Annala M, Aggarwal R, et al. Concordance of Circulating Tumor DNA and Matched Metastatic Tissue Biopsy in Prostate Cancer. J Natl Cancer Inst. 2018;110(1):djx118.

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