Guardant360® CDx Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ (sotorasib) KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer

Guardant Health liquid biopsy can help identify the 13 percent of patients harboring the KRAS G12C mutation, a previously undruggable target, who may be appropriate for LUMAKRAS

Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved the Guardant360^® CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from LUMAKRAS™ (sotorasib), an FDA-approved KRAS^G12C inhibitor developed and manufactured by Amgen.

The Guardant360 CDx FDA approval was based on clinical validation data from the CodeBreaK 100 trial evaluating sotorasib in patients with locally advanced or metastatic NSCLC. Patients identified with the KRAS G12C mutation using the Guardant360 CDx demonstrated an objective response rate consistent with those identified using traditional tissue-based biomarker testing.

Lung cancer is the leading cause of cancer death in the U.S.¹ and NSCLC accounts for approximately 84 percent of all lung cancers.² It is estimated that 66 percent of patients with NSCLC have advanced or metastatic disease at initial diagnosis,³ and two out of three with lung adenocarcinoma harbor a driver mutation.⁴ Clinical guidelines recommend comprehensive genomic profiling at diagnosis, for all patients with advanced NSCLC, to evaluate whether they have one of the growing list of actionable and emerging biomarkers with associated treatment options.^5-7 KRAS G12C is one of the most common driver mutations in NSCLC, occurring in 13 percent of patients, and until now, FDA-approved targeted therapy options did not exist.^4,8

“The approval of LUMAKRAS represents a significant medical advancement for patients with advanced non-small cell lung cancer who harbor the KRAS G12C mutation because it is the first and only targeted therapy now available to them,” said Darryl Sleep, M.D., Amgen chief medical officer and senior vice president of Medical Affairs “However, patients can only benefit from targeted therapies, or personalized treatments, if they are tested for biomarkers. Today’s FDA approval of Guardant360 CDx, offers an important development in biomarker testing by providing a high-quality, blood-based testing option for patients.”

“In the CodeBreaK 100 phase 2 clinical trial, which was the basis for the FDA approval, sotorasib demonstrated compelling efficacy and tolerability in patients with KRAS G12C-mutated non-small cell lung cancer. This approval represents a historic milestone for patients with this mutation,” said Vamsidhar Velcheti, M.D., director of thoracic oncology at NYU Langone Health Perlmutter Cancer Center. “This new targeted therapy, reinforces once again why comprehensive biomarker testing at diagnosis is critical. Having additional options, including the availability of a blood-based testing option, such as the Guardant360 CDx, will help to more quickly identify the patients who may benefit and help guide treatment decisions.”

“This groundbreaking new therapy from Amgen, LUMAKRAS, underscores the importance of incorporating comprehensive genomic profiling in routine clinical practice to ensure all patients are evaluated for KRAS G12C and the growing list of other actionable mutations that can be treated with targeted therapies shown to significantly improve clinical outcomes,” said Helmy Eltoukhy, Guardant Health CEO. “By offering an FDA-approved companion diagnostic that can quickly deliver comprehensive results from a simple blood test, clinicians can have greater confidence using the test, and patients benefit from less invasive testing and shorter wait times to see whether they are eligible for a targeted therapy such as LUMAKRAS.”

For oncologists, the FDA-approved Guardant360 CDx provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.

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 commercially launched liquid biopsy-based Guardant360^®, Guardant360 CDx, and GuardantOMNI^® tests for advanced stage cancer patients, and Guardant Reveal™ test for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of 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, 2020 and in its other reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2021. 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. CDC Centers of Disease Control and Prevention. https://www.cdc.gov/cancer/dcpc/research/update-on-cancer-deaths/index.htm#:~:text=Lung%20cancer%20is%20the%20leading,24%25%20of%20all%20cancer%20deaths. Accessed online May 24, 2021
2. Cancer.net. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed online May 24, 2021
3. Ahmadzada T, Kao S, Reid G, Boyer M, Mahar A, Cooper WA. An Update on Predictive Biomarkers for Treatment Selection in Non-Small Cell Lung Cancer. Journal of Clinical Medicine. 2018; 7(6):153. doi.org/10.3390/jcm7060153
4. Pakkala S, Ramalingam, Personalized therapy for lung cancer: striking a moving target. JCI Insight. 2018;3(15):e120858. doi.org/10.1172/jci.insight.120858
5. Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Journal of Thoracic Oncology. 2018 Mar;13(3):323-358. doi: 10.1016/j.jtho.2017.12.001
6. Kalemkerian GP, Narula N, Kennedy EB, et al. Molecular Testing Guideline for the Selection of Patients With Lung Cancer for Treatment With Targeted Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Clinical Practice Guideline Update. Journal of Clinical Oncology. 2018 Mar 20;36(9):911-919. doi: 10.1200/JCO.2017.76.7293
7. Gregg JP, Li T, Yoneda KY. Molecular testing strategies in non-small cell lung cancer: optimizing the diagnostic journey. Translational Lung Cancer Research. 2019 Jun;8(3):286-301. doi: 10.21037/tlcr.2019.04.14
8. Biernacka A, Tsongalis PD, Peterson JD, et al. The potential utility of re-mining results of somatic mutation testing: KRAS status in lung adenocarcinoma. Cancer Genetics. 2016;209(5):195-198. doi:10.1016/j.cancergen.2016.03.001

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