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

REDWOOD CITY, Calif .– (BUSINESS WIRE) – Guardant Health, Inc. (Nasdaq: GH) announces that the United States Food and Drug Administration (FDA) has approved Guardant360® CDx assay as the first and only liquid biopsy companion diagnostic for profiling tumor mutations, or complete genomic profile, to identify patients with locally advanced or metastatic non-small cell lung cancer who harbor the KRAS Mutation G12C and may benefit from LUMAKRAS ™ (sotorasib), an FDA approved KRASG12C inhibitor developed and manufactured by Amgen.

FDA approval of Guardant360 CDx 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 The G12C mutation using Guardant360 CDx demonstrated an objective response rate consistent with those identified using traditional tissue biomarker assays.

Lung cancer is the leading cause of cancer death in the United States1 and NSCLC accounts for about 84 percent of all lung cancers.2 It is estimated that 66% of patients with NSCLC have advanced or metastatic disease at the time of initial diagnosis,3 and two out of three with lung adenocarcinoma harbor a motor mutation.4 Clinical guidelines recommend full genomic profiling at the time of diagnosis, for all patients with advanced NSCLC, to assess whether they have any of the growing list of actionable and emerging biomarkers with associated treatment options.5-7 KRAS G12C is one of the most common mutations in NSCLC, occurring in 13% of patients, and until now, targeted therapy options approved by the FDA have not existed.4.8

“The approval of LUMAKRAS represents a significant medical breakthrough for patients with advanced non-small cell lung cancer who harbor the KRAS The G12C mutation because it’s the first and only targeted therapy available to them, “said Darryl Sleep, MD, medical director of Amgen and senior vice president of medical affairs.” However, patients cannot benefit from targeted therapies, or personalized treatments, only if they are tested for biomarkers. The current FDA approval of Guardant360 CDx offers a significant development in biomarker testing by providing a high quality blood test option for patients.

“In the CodeBreaK 100 phase 2 clinical trial, which served as the basis for FDA approval, sotorasib demonstrated convincing 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, MD, director of thoracic oncology at NYU Langone Health Perlmutter Cancer Center. “This new, targeted therapy reinforces once again why comprehensive biomarker testing at the time of diagnosis is essential. Having additional options, including the availability of a blood test option, like the Guardant360 CDx, will help identify patients who might benefit more quickly and guide treatment decisions. ”

“This revolutionary new therapy from Amgen, LUMAKRAS, highlights the importance of incorporating a complete genomic profile into routine clinical practice to ensure that all patients are evaluated for KRAS G12C and the growing list of other workable mutations that can be treated with targeted therapies dramatically improve clinical outcomes, ”said Helmy Eltoukhy, CEO of Guardant Health. “By providing an FDA-approved companion diagnostic that can quickly provide complete results from a simple blood test, clinicians can have greater confidence in using the test, and patients benefit from less invasive and time-consuming testing. shorter waits to see if they are eligible for a targeted test. therapy such as LUMAKRAS. ”

For oncologists, the FDA-approved Guardant360 CDx delivers complete genomic results from a simple seven-day blood test, helping them overcome the limitations of tissue biopsies to quickly obtain clinically relevant information in time to match. patients with optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and treatment guidelines for NSCLC.

Since its introduction, the Guardant360 test has gained wide acceptance for blood-based complete genomic profiling with over 200 peer-reviewed publications. It has been trusted by over 9,000 oncologists, with over 150,000 tests performed to date, and is widely covered by Medicare and many private payers, accounting for over 200 million lives.

About Guardant Health

Guardian health is a leading precision oncology company that aims to help beat cancer on a global scale through its proprietary blood tests, large datasets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient outcomes, and reduce healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially theGuardant360 Unscheduled Liquid Biopsy®, Guardant360 CDx and GuardantOMNI® tests for patients with advanced cancer and Guardant Reveal ™ test for patients with early cancer. These tests are fueling the development of its LUNAR screening program, which aims to meet the needs of asymptomatic people eligible for cancer screening and people at higher risk of 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 uses, values, benefits, and potential benefits of Guardant Health’s liquid biopsy testing or analysis, which involve risks and uncertainties. likely to cause actual results to vary. materially in relation to the anticipated results and the expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual results could differ materially from these statements due to a number of factors. These risks and uncertainties, and others that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by forward-looking statements made in this press release, include those discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Position and Results of Operations” 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 contained in this press release are based on information available to Guardant Health at the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect your ut change in its expectations or any change in the events, conditions or circumstances on which such a statement is based, except as Required by law. These forward-looking statements should not be taken as representing the views of Guardant Health as of any date subsequent to the date of this press release.

The references

  1. CDC Centers for 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 Lung Cancer Therapy: Hitting 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 Guidelines for Selecting Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, International Association for the Study of lung cancer and the Association for Molecular Pathology. Journal of Thoracic Oncology. March 2018; 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. March 20, 2018; 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: optimization of the diagnostic pathway. Translational research in lung cancer. June 2019; 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-extracting somatic mutation test results: KRAS status in pulmonary adenocarcinoma. Cancer genetics. 2016; 209 (5): 195-198. doi: 10.1016 / j.cancergen.2016.03.001


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