Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer
September 07 2023 - 5:00AM
Business Wire
New data highlights two novel proteomic tests that support
treatment decision making in patients with non-small cell lung
cancer (NSCLC):
- Expanded analysis of the VeriStrat® host immune classifier’s
ability to predict immune checkpoint inhibition (ICI) response in
patients with advanced stage NSCLC
- The ability of the Risk of Recurrence pipeline test to stratify
time to recurrence and overall survival in patients with stage I
NSCLC
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, announced today
that two abstracts will be presented at the International
Association for the Study of Lung Cancer (IASLC) 2023 World Lung
Conference on Lung Cancer (WCLC). The first presentation showcases
a new analysis of the large multi-center observational registry
study INSIGHT (Clinical Effectiveness Assessment of VeriStrat®
Testing and Validation of Immunotherapy Tests in NSCLC Subjects,
NCT03289780) demonstrating the ability of the VeriStrat host immune
classifier to predict response to immune checkpoint inhibitor (ICI)
regimens in patients with advanced stage non-small cell lung cancer
(NSCLC).
The INSIGHT trial, which recently reached its enrollment goal of
5,000 patients with NSCLC, previously yielded data showing that
patients with ≥50% PD-L1 status classified as Host Immune
Classifier Cold (HIC-C), also known as VeriStrat Poor, had superior
median overall survival when receiving ICI plus chemotherapy versus
ICI alone. The expanded analysis confirms these findings and
concludes that patients with <50% PD-L1 status classified as
Host Immune Classifier Hot (HIC-H), also known as VeriStrat Good,
had comparable overall survival when receiving either ICI alone or
in combination with chemotherapy.
“These findings highlight the importance of characterizing a
patient’s immune response to lung cancer to guide immunotherapy
treatment decisions,” said Wallace Akerley, MD, principal
investigator of the INSIGHT study. “The growing body of evidence
shows the VeriStrat test is complementary to current standard of
care and its use would improve overall patient outcomes by
identifying subsets of patients who would benefit from
Veristrat-directed selection of immunotherapy regimen.”
The second presentation details the performance of a
pre-surgical, blood-based Risk of Recurrence test in three
independent cohorts. Patients with early stage lung cancer have
favorable outcomes, but many of these patients experience a
recurrence which results in a poor prognosis. The test was designed
to identify patients with a high probability of recurrence that
could be considered for more aggressive treatment or enhanced
surveillance. This initial validation study evaluated nearly 800
patients with Stage I NSCLC and demonstrated the test’s ability to
stratify three distinct groups of patients based on their proteomic
profile with high, intermediate, or low risk of recurrence.
Furthermore, incorporating the adenocarcinoma grade, a conventional
risk factor for recurrence, improved the performance of the
test.
“It is crucial to be able to determine which 10-15% of early
stage lung cancer patients will recur within 3-5 years after their
tumor is completely removed by surgery, and we are encouraged that
our model, especially when incorporating the IASLC Histologic
Grading System, may lead to more accuracy in this regard,” said
Harvey Pass, MD lead author of the abstract. “Nevertheless, this
work requires further external validation with other cohorts of
Stage I lung cancer patients before it could be used clinically to
determine who needs appropriate adjuvant therapy.”
Following are details about the presentations at the 2023
WCLC:
Title (P2.07-06): Real World Efficacy of First-Line
Immunotherapy +/- Chemotherapy in Advanced NSCLC Stratified by
Serum Proteomics Presenter: Wallace Akerley, MD, Director of
Lung Cancer Disease Center of Excellence at Huntsman Cancer
Institute, University of Utah Session P2.07: Metastatic
Non-small Cell Lung Cancer – Immunotherapy - Retrospective Date
& Time: Monday, Sept. 11, 2023, 18:00 - 20:00 (SGT)
Location: Exhibit Hall, Level 4 (Row 10)
Title (P1.25-13): Enhanced Assessment of Recurrence Risk
of Stage I NSCLC by Combined Adenocarcinoma Grading System and
Serum Proteomic Testing Presenter: Harvey Pass, MD, Vice
Chair, Research for Cardiothoracic Surgery at NYU Langone Health,
and executive committee member for the NYU Lung Cancer Center of
the Perlmutter Cancer Institute Session P1.25: Early-Stage
Non-small Cell Lung Cancer - Pushing the Boundaries: Changing
Paradigms and Outcomes Date & Time: Sunday, Sept. 10,
2023, 17:30 - 19:30 (SGT) Location: Exhibit Hall, Level 4
(Row 32)
About Biodesix
Biodesix is a leading data-driven diagnostic solutions company
with a focus in lung disease. The Company develops diagnostic tests
addressing important clinical questions by combining multi-omics
through the power of artificial intelligence. Biodesix offers five
Medicare-covered tests for patients with lung diseases. The blood
based Nodify Lung® nodule risk assessment testing strategy,
consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates
the risk of malignancy in pulmonary nodules, enabling physicians to
better triage patients to the most appropriate course of action.
The blood based IQLung™ strategy for lung cancer patients
integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS®
test and the VeriStrat® test to support treatment decisions across
all stages of lung cancer with results in an average of two to
three business days, expediting the time to treatment. Biodesix
also leverages the proprietary and advanced Diagnostic Cortex® AI
(Artificial Intelligence) platform, to collaborate with many of the
world’s leading biotechnology and pharmaceutical companies to solve
complex diagnostic challenges in lung disease. For more information
about Biodesix, visit biodesix.com.
Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements contained in this press release other
than statements of historical fact, are forward-looking statements.
The words “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,”
“opportunity,” “goals,” or “should,” and similar expressions are
intended to identify forward-looking statements. Such statements
are based on management’s current expectations and involve risks
and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors. Biodesix has based these
forward-looking statements largely on its current expectations and
projections about future events and trends. These forward-looking
statements are subject to a number of risks, uncertainties, and
assumptions. Forward-looking statements may include information
concerning the impact of the COVID-19 pandemic on Biodesix and its
operations, its possible or assumed future results of operations,
including descriptions of its revenues, profitability, outlook, and
overall business strategy. Forward-looking statements are
inherently subject to risks and uncertainties, some of which cannot
be predicted or quantified. The Company's ability to continue as a
going concern could cause actual results to differ materially from
those contemplated in this press release and additionally, other
factors that could cause actual results to differ materially from
those contemplated in this press release can be found in the Risk
Factors section of Biodesix’s most recent annual report on Form
10-K, filed March 14, 2022 or subsequent quarterly reports on Form
10-Q during 2022, if applicable. Biodesix undertakes no obligation
to revise or publicly release the results of any revision to such
forward-looking statements, except as required by law. Given these
risks and uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements. All forward-looking
statements are qualified in their entirety by this cautionary
statement.
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chris.brinzey@westwicke.com (339) 970-2843
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