Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer

Life Sciences Review | Saturday, September 30, 2023

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

BOULDER - Biodesix, Inc. (Nasdaq: BDSX), 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 has recently achieved its enrollment target of 5,000 patients with Non-Small Cell Lung Cancer (NSCLC), had previously generated data indicating that patients with a PD-L1 status of ≥50%, categorized as Host Immune Classifier Cold (HIC-C) or VeriStrat Poor, exhibited improved median overall survival when treated with Immune Checkpoint Inhibitors (ICI) in combination with chemotherapy, compared to those receiving ICI alone. A more extensive analysis now substantiates these findings and concludes that patients with a PD-L1 status of <50%, identified as Host Immune Classifier Hot (HIC-H) or VeriStrat Good, demonstrated similar overall survival outcomes whether treated with 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 focuses on the evaluation of a pre-surgical, blood-based Risk of Recurrence test across three independent cohorts. Patients diagnosed with early-stage lung cancer generally have positive outcomes, but a considerable number experience recurrence, leading to a less favorable prognosis. The primary objective of the test is to identify patients with a heightened likelihood of recurrence, enabling them to be considered for more aggressive treatment or enhanced surveillance.

In this initial validation study, approximately 800 patients with Stage I Non-Small Cell Lung Cancer (NSCLC) were assessed. The study successfully categorized patients into three distinct risk groups (high, intermediate, or low risk of recurrence) based on their proteomic profiles. Additionally, the incorporation of adenocarcinoma grade, a well-established risk factor for recurrence, contributed to enhancing the test's performance.

“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.”

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Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer