TEST:

VeriStrat®

Our findings suggest that the prognostic value of the VeriStrat test may vary based on the treatment regimen. In clinical scenarios utilizing ICI monotherapy for patients with PD-L1 levels <50%, the role of VeriStrat seems more significant. A prospective study with a larger sample size for validation is warranted.

P=N/A; Recruiting --> Active, not recruiting

P=N/A; This newly acquired information improves our understanding of how VS can accurately predict patient response to therapy. It opens up additional studies that can expand our understanding even further.

Furthermore, identifying VS-P group associated with inferior efficacy-toxicity ratio may be of clinical significance in immune-oncology. Further validation in a larger cohort is warranted.

"Biodesix, Inc...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...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 second presentation details the performance of a pre-surgical, blood-based Risk of Recurrence test in three independent cohorts."

"Biodesix, Inc...announced today that the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat^® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) has completed enrollment of 5,000 patients with non-small cell lung cancer (NSCLC). The study was designed to further validate the utility of the VeriStrat^® test, a novel predictive and prognostic blood-based host immune classifier, and its ability to support treatment decisions for patients with NSCLC across different therapeutic approaches....A recent analysis from this study has been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Singapore in September 2023."

"Biodesix, Inc...announced...that three new scientific abstracts will be presented as part of the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting including a poster presented by Friends of Cancer Research (FoCR) featuring genomic data contributed by Biodesix and other organizations...This poster highlights long term patient outcomes from the ctMoniTR Project, a study evaluating the prognostic value of changes in circulating tumor DNA (ctDNA) in patients treated with targeted therapies. The new data release indicates that ctDNA shows promise as an early endpoint to support drug development and regulatory decision-making."

"Biodesix, Inc...announced...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) 37th Annual Meeting."

"Biodesix, Inc...announced the award of a U.S. Federal Supply Schedule contract which includes the Veterans Health Administration providing care for U.S. Veterans and Military Health System providing care for active-duty service members and their families. The contract covers the company’s entire lung diagnostic portfolio: Nodify XL2®, Nodify CDT®, VeriStrat®, GeneStrat® ddPCR, and GeneStrat NGS™ testing."

P2; Active, not recruiting --> Completed

P=NA | N=61 | "Biodesix, Inc...announced...will present the results of a retrospective analysis at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC2022) on August 8, 2022 in Vienna, Austria....The analysis from Northwestern University included patients with advanced-stage non-small cell lung cancer (NSCLC) who received Immune Checkpoint Inhibitors (ICIs) as monotherapy or in combination with chemotherapy with PD-L1 <50%. Patients underwent Biodesix’s blood-based VeriStrat proteomic testing from 2016 to 2021. This data demonstrated that the VeriStrat test result was predictive of Progression Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC with low or negative PD-L1 treated with ICIs."

Our results demonstrate that the blood-based proteomic test result is predictive of PFS and OS in NSCLC with low or negative PC-L1 treated with ICIs. Patients whose VeriStrat status was Good had better PFS and OS compared to the patients whose VeriStrat status was Poor.

"Spesana...and Biodesix Inc...announced today that they have partnered to further streamline and automate the use of molecular diagnostics in clinical workflows across the United States utilizing Spesana’s digital platform solutions for comprehensive lung cancer management...Spesana’s partnership with Biodesix includes a healthcare platform for clinicians that is beyond the various electronic medical records or lab portals. The platform will incorporate electronic ordering of molecular testing including Biodesix’s blood-based Nodify Lung® Nodule Risk Assessment Testing (Nodify XL2® & Nodify CDT ® tests) and IQlung™ Testing (GeneStrat ® ddPCR, GeneStrat NGS™, & VeriStrat ® tests), all part of a Biodesix’s blood-based treatment guidance portfolio with industry-leading turnaround times."

"Biodesix, Inc...announced new interim data published from the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) utilizing its novel predictive and prognostic blood-based host immune classifier (the VeriStrat test) to stratify Immune checkpoint inhibition (ICI) treatment response in patients with advanced non-small cell lung cancer(NSCLC). The study, titled 'Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer,' was published in the Journal of Immunotherapy of Cancer (JITC)"

P=N/A; Blood-based HIC proteomic testing provides clinically meaningful information for immunotherapy treatment decision in NSCLC independent of PD-L1. The data suggest that HIC-C patients should not be treated with ICI alone regardless of their PD-L1 expression.

Patient- and physician-assessment of PS do not always match, many alternate measures to PS are prognostic of survival and tracker-based methods are objective and feasible in clinical practice.

Patient- and physician-assessment of PS do not always match, many alternate measures to PS are prognostic of survival and tracker-based methods are objective and feasible in clinical practice.

"Conclusion Blood-based proteomic testing has the potential as a predictive biomarker for survival outcomes in NSCLC patients receiving an ICI-based regimen. Its predictive role may defer according to PD-L1 status, thus requiring further studies."

Overall, a machine learning algorithm incorporating mass spectral data and AFP values from serum samples offers a novel approach to diagnose HCC. Given the small sample size of the Independent Validation set, a further independent, prospective study is warranted.

There was no statistically significant association between the VeriStrat test and the development of irAEs . Further studies are warranted to investigate proper serum based proteomic assay to predict the development of irAE.

After progression during antiestrogen therapy, the addition of everolimus, without changing the hormonal therapy, resulted in a median PFS of 6.6 months, suggesting efficacy in patients with HR/HER2 MBC.

P=N/A | "For some patients with NSCLC, disease states and prognosis can change in response to therapy. Longitudinal proteomic testing may be a viable method to monitor changes in disease state and host immune response to guide treatment."

P=N/A, N=5000, Recruiting, Biodesix, Inc. | N=1000 --> 5000 | Trial completion date: Dec 2020 --> Dec 2025 | Trial primary completion date: Jun 2019 --> Dec 2025

Our study indicated that VS might be considered as a novel and valid method to predict the efficacy of pemetrexed-based therapy and identify a subset of advanced lung adenocarcinoma patients who had intrinsic resistance to pemetrexed based regimens. However, larger sample studies are still needed to further confirm this result.

P2;Recruiting --> Completed | N=100 --> 38

The clinical outcomes of 32 patients who received programmed cell death 1 (PD-1) inhibitors nivolumab or pembrolizumab were analyzed by VeriStrat status. Multivariate analysis showed that the VeriStrat status was significantly correlated with PFS and OS in NSCLC patients treated with ICIs (P=0.017, P=0.034, respectively). MS-based serum proteomic signature has potential as a biomarker for survival outcome in NSCLC patients receiving immunotherapy.

The summary effect size for OS HRs around 0.4-0.5 indicates that the expected median survival of those with a VSGood classification is approximately 2-2.5 times as long as those with VSPoor. The robust prognostic performance of the VeriStrat test across various lines of therapy and treatment regimens has clinical implications for treatment shared decision-making and potential for novel treatment strategies.

"ET appears to be superior to EP due to better PFS and higher response rates, especially for patients with high MET expression and good VeriStrat. The greater hematological toxicity in the ET regimen is non-negligible."

"In this small set of front-line patients with RNA pathway analyses and known VS poor or good labels, differential expression of acute phase reactants was found in VS poor patients. DAVID and KEGG pathways were differentially enriched and may reveal potential targets to mitigate prognosis in poor risk NSCLC. Research Funding: Rush Lung Cancer Research Fund"

P2 | "A Bayesian continuous monitoring rule for futility has not been triggered for either arm. Research Funding: Aveo"

"VeriStrat was not a predictive marker for survival when considering first-line erlotinib for patients with NSCLC who had poor PS and were not recommended for platinum doublet therapies. However, VeriStrat was an independent prognostic marker of survival. It represents an objective measurement that could be considered alongside other patient factors to provide a more refined assessment of prognosis for this particular patient group. VSG patients could be selected for treatment trials because of better survival, while VSP patients can continue to be treated conservatively or offered trials of less toxic agents."

"This study suggests that VeriStrat testing could enhance the prognostic role of performance status and smoking status and replicates findings from other trials that showed that the VeriStrat test identifies EGFR mutation-positive patients likely to have a poor response to EGFR tyrosine kinase inhibitors (TKIs). Although these findings should be confirmed in other populations, VeriStrat use could be considered in EGFR mutation-positive patients as an additional prognostic tool, and these results suggest that EGFR mutation-positive patients with VeriStrat "poor" classification could benefit from other therapeutic agents given in conjunction with TKI monotherapy."