Guardant360® CDx Receives FDA Approval as First & Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ (sotoras...
May 28 2021 - 1:15PM
Business Wire
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 KRASG12C
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
- 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
- Cancer.net.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed online May 24, 2021
- 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
- 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
- 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
- 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
- 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
- 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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Investor Contact: Carrie Mendivil
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