First results from PEGASUS trial reported at ESMO show promise for use of liquid biopsy to guide adjuvant treatment of colon cancer
23 Outubro 2023 - 4:45AM
Business Wire
- Study results suggest Guardant RevealTM circulating tumor DNA
blood test may help clinicians decide to pursue more or less
aggressive post-surgical chemotherapy regimens
- PEGASUS is first clinical utility trial for tissue-free
detection of minimal residual disease
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced that initial results from the PEGASUS
trial suggest liquid biopsy may be used in post-surgical clinical
management to reduce unnecessary toxicity from chemotherapy and
improve the response to standard chemotherapy regimens in patients
with stage III or high-risk stage II colon cancer. Results from the
trial, which is an ISS study sponsored by IFOM ETS – the AIRC
Institute of Molecular Oncology in Milan, Italy, and supported by
Guardant Health, were presented today by study investigators at the
ESMO Congress in Madrid, Spain.
One of the first prospective studies using liquid biopsy, the
PEGASUS trial includes 135 patients recruited from 11 cancer
centers in Italy and Spain. The study is assessing the feasibility
of escalating or de-escalating adjuvant (post-surgery) chemotherapy
based on the presence or absence of minimal residual disease (MRD)
as indicated by circulating tumor DNA (ctDNA) detected by the
Guardant Reveal blood test at multiple timepoints. Patients with
positive results receive standard chemotherapy, while patients with
negative results receive a milder therapy that is associated with
significantly less acute and chronic neurological toxicity compared
to standard treatment. Liquid biopsy is repeated several times
along the course of treatment to reveal opportunities to treat
patients safely with lower toxicity regimens, identify therapeutic
resistance, and tailor chemotherapy to be stronger when needed.
Initial results show that 34% of patients with a positive liquid
biopsy result after surgery had the cancer return, while only 10%
of patients with a negative result experienced a relapse.
Approximately 40% of patients converted from ctDNA-positive to
ctDNA-negative after treatment, suggesting treatment efficacy of
chemotherapy for some patients.
“We are confident that, once confirmed by the results of several
other ongoing international studies on liquid biopsy, our findings
may help influence the modification of clinical practice guidelines
for the treatment of operable colon cancer, supporting adjuvant
therapy scale-down or elimination in patients with negative liquid
biopsy, and chemotherapy personalization in the case of molecular
non-response,” said Silvia Marsoni, MD, PhD, the designer of the
PEGASUS trial and head of the precision oncology unit at IFOM. “A
shift from the current paradigm of one-size-fits-all chemotherapy
toward a new paradigm of tailored therapies is not the only
expected impact of the PEGASUS trial. It will allow us to explore
the biology of micro-metastatic tumors, for which we need to find
new and more effective therapies.”
“Currently a significant number of patients with stage II and
III colon cancer do not receive the intended benefit from adjuvant
chemotherapy due to limits of current prognostic criteria. There is
a significant need for better prognostic tools to guide clinical
management in this patient population,” said Craig Eagle, MD,
Guardant Health chief medical officer. “These initial trial results
are promising and suggest that the Guardant Reveal liquid biopsy
test can provide a sensitive tool to detect MRD and predict
recurrence of the cancer, helping oncologists make informed
treatment decisions that improve outcomes for their patients.”
For more information about the PEGASUS study, visit:
https://guardanthealth.com/clinical-studies/#early-stage-studies--content
About Guardant Health
Guardant Health is a leading precision oncology company focused
on helping conquer cancer globally through use of its proprietary
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 Guardant360®, Guardant360 CDx,
Guardant360 TissueNext™, Guardant360 Response™, and
GuardantINFINITY® tests for advanced stage cancer, and Guardant
Reveal™ for early-stage cancer. The Guardant Health screening
portfolio, including the commercially launched Shield™ test, aims
to address the needs of individuals eligible for cancer screening.
For more information, visit guardanthealth.com and follow the
company on LinkedIn and Twitter.
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, 2022, and any
current and periodic reports filed with or furnished to the
Securities and Exchange Commission thereafter. 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.
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Investor Contact: investors@guardanthealth.com
Media Contact: Michael Weist press@guardanthealth.com +1
650-647-3643
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