Biodesix Presents New Data from the INSIGHT Study at the 2022 Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On November 10, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that Wallace Akerley, MD, medical oncologist at the University of Utah Huntsman Cancer Institute, will present new interim data from the large multi-center prospective observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (Press release, Biodesix, NOV 10, 2022, View Source [SID1234623690]). The data highlights the ability of the VeriStrat test, a novel predictive and prognostic blood-based host immune classifier, to stratify immune checkpoint inhibition (ICI) treatment response in patients with advanced non-small cell lung cancer (NSCLC). The poster, titled "Host Immune Profiling in First-line Immunotherapy Treated Advanced Stage Non-Small Cell Lung Cancer: Results from the INSIGHT Registry Study," will be presented on Friday, November 11th, 2022.

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Results from a prior analysis of the VeriStrat test published in the Journal for ImmunoTherapy of Cancer (JITC) in October 2021 demonstrated that approximately 2,000 patients with at least one year of follow up classified by VeriStrat as host immune classifier hot (HIC-Hot) had better outcomes, on average living 2-3 times longer when compared to patients classified by VeriStrat as host immune classifier cold (HIC-C). A classification of HIC-H, also known as VeriStrat Good, implies that the normal tumor directed immunity is active and patients are potentially responsive to therapies that boost immune response. HIC-C classification, also known as VeriStrat Poor, correlates to what experts refer to as an "immune desert," where tumor directed immunity is compromised.

The new data expands the analysis population to a total of 3,040 patients and confirms the ability of the VeriStrat test to predict outcomes in patients treated with immunotherapy regimens. Patients with HIC-C classification had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone (8.2 months versus 5.6 months, respectively). Furthermore, patients with high PD-L1 expression and with HIC-C classification had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone (14.3 months versus 3.3 months, respectively).

"Real World data can answer questions not addressed by registrational studies. HIC (VeriStrat) is a biomarker of immune therapy and these results suggest that HIC-C (VeriStrat Poor) patients should not be treated with single agent ICI therapy regardless of their PD-L1 expression," said Dr. Akerley, principal investigator of the INSIGHT study. "Immunotherapy has transformed treatment options for patients with non-small cell lung cancer, but it is challenging to know which standard of care regimens will be most effective. This new data from the INSIGHT study shows how a biomarker-driven strategy can help determine optimal treatment approaches for these patients."