New Front-Line Data Presented at Multidisciplinary Thoracic
Cancers Symposium
BOULDER, Colo. & SAN DIEGO–(BUSINESS WIRE)–Biodesix®
today presented new data demonstrating that the VeriStrat®
test is predictive of outcomes for patients with non-small cell lung
cancer (NSCLC) treated with immune checkpoint inhibitors (ICIs) in the
first-line setting, even when adjusted for PD-L1 status. Study results
were presented at a poster session of the Multidisciplinary Thoracic
Cancers Symposium in San Diego, titled, “Real-World
Performance of Blood-Based Proteomic Profiling in Immunotherapy
Treatment in Advanced Stage NSCLC.”
The prospectively designed observational study (NCT03289780) is
currently enrolling NSCLC patients at 33 U.S. sites and will follow
patient outcomes for 18 months. A pre-planned interim analysis was
conducted with the first 1000 patients enrolled with at least 12 months
follow-up. Results for the subset of patients with advanced NSCLC
treated with a front-line ICI, with or without chemotherapy (n = 85; all
frontline therapies n = 419), suggest that incorporating the host immune
response as part of the initial patient assessment provides clinically
meaningful information when choosing a frontline therapy for NSCLC.
Immune checkpoint inhibitors have emerged as standard treatment for
wild-type patients with NSCLC based on established superiority over
chemotherapy in efficacy. However, it is known that not all patients
testing positive for PD-L1 respond to ICIs.
“Additional studies are needed to establish the clinical utility of
biomarker testing when choosing appropriate treatment regimens,” said
Patricia Rich, M.D., medical oncologist and Medical Director of Thoracic
Oncology at Cancer Treatment Centers of America. “Real-world data from
this large registry observational study suggests that the overall
survival for patients receiving a frontline ICI added to chemotherapy,
or alone, may not be significantly different from platinum-based
chemotherapy. This is potentially good news for patients that are not
eligible for ICI therapy, cannot tolerate it, or simply cannot afford
it.”
When patients were stratified by the VeriStrat blood-based host response
proteomic test, the individuals identified as VeriStrat Poor (~25
percent) had significantly lower overall survival with any ICI based
regimen, compared to individuals identified as VeriStrat Good (~75
percent), even when adjusted for PD-L1 status in a multi-variate
analysis.
Data highlights:
-
The VeriStrat test is predictive of outcomes for all treatment
regimens and lines of therapy, including immunotherapy, even when
adjusted for PD-L1 status -
Patients with a VS Good result had significantly higher median OS
compared to VS Poor patients on both immuno-monotherapy and
immunotherapy in combination with chemotherapy -
Patients with a VS Poor result did not benefit from treatment with
immunotherapy or the addition of immunotherapy to platinum-based
therapy
“Immunotherapy has improved outcomes for many advanced stage patients
with NSCLC but is not beneficial for everyone. There is a clinical need
for a test to predict outcomes, including overall survival and response,
that helps guide physicians and patients to the right treatment strategy
in order to save critical time, reduce unnecessary side effects, and
minimize treatment cost for ineffective therapies,” said Linda Traylor,
Ph.D., Vice President of Clinical Development and Medical Affairs for
Biodesix. “These data add to the already extensive and growing body of
evidence supporting the VeriStrat test results as predictive of outcomes
across treatment choices, now including ICIs. Biodesix is focused on
supporting research that identifies effective therapies to treat the
aggressive VeriStrat Poor disease state.”
The VeriStrat test is a multivariate, mass-spectrometry based test that
measures circulating proteins in the blood serum or plasma of patients
with NSCLC. Test results assign a good (VS Good) or poor (VS Poor)
classification to patient samples. Multiple studies support that
patients with a VS Good result have a better prognosis than patients
with a VS Poor result, independent of current clinical prognostic
indicators and treatment choice. VeriStrat testing has been validated in
more than 70 studies with more than 6,600 patients and is covered by
Medicare and most private health insurers.
About Biodesix
Biodesix is a lung cancer diagnostic company addressing the continuum of
patient care from early diagnosis of lung nodules through late stage
cancer. The company develops diagnostic tests addressing important
clinical questions by combining simple blood draws and multi-omics with
the power of artificial intelligence. Biodesix is the first company to
offer three best-in class tests for patients with non-small cell lung
cancer, and multiple pipeline tests including one with the potential to
identify patients who may benefit from immunotherapies. The Biodesix
Lung Reflex strategy integrates the GeneStrat® and VeriStrat®
tests to support treatment decisions with results in 72 hours. The
BDX-XL2 nodule test evaluates the risk of malignancy, enabling
physicians to triage patients to the most appropriate course of action.
Biodesix also partners with the world’s leading biotechnology and
pharmaceutical companies to develop companion diagnostics. For more
information about Biodesix, please visit www.biodesix.com.
Contacts
Kena Hudson for Biodesix
Kena@HudBio.com
(510)
908-0966