Two studies demonstrating the clinical utility of the VeriStrat test from Biodesix, Boulder, Colo, for the management of patients with non-small cell lung cancer (NSCLC) were presented at the recent World Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer. A Biodesix investigational test developed using the company’s Diagnostic Cortex platform was also evaluated in one of the studies, providing further data regarding the potential value of a proteomic test to help physicians stratify patients for immunotherapies.
Glenwood D. Goss, MD, University of Ottawa.
“VeriStrat appears to be a robust assay and should be used for EGFR wild-type patients with squamous cell lung cancer,” says study author Glenwood D. Goss, MD, professor of medicine and an oncologist in the division of medical oncology at the University of Ottawa.
In the LUX-Lung 8 study, afatinib (an irreversible ErbB family blocker) was compared with erlotinib (a reversible EGFR tyrosine-kinase inhibitor) in patients with EGFR wild-type squamous cell carcinoma of the lung who had progressed after at least four cycles of platinum-doublet chemotherapy.1,2 In a subanalysis of the LUX-Lung 8 study, afatinib-treated patients classified as VeriStrat-good were found to be nearly four times as likely as patients classified as VeriStrat-poor to survive for 12 months or longer.
Data reported in oral and poster presentations at the lung cancer conference demonstrated that the VeriStrat test identifies a subset of patients who have significantly better outcomes on afatinib versus erlotinib. VeriStrat-good patients experienced progression-free survival of 3.3 months versus 2.0 months, and overall survival of 11.5 months versus 9 months.
In the long-term responder subset of patients who survived at least 1 year, afatinib conferred a median survival benefit of nearly 2 years. Several possible molecular or clinical biomarkers indicative of long-term response to afatinib were evaluated, including VeriStrat status. Among the long-term responders, 86% were VeriStrat-good (versus 62% VeriStrat-good in the overall afatinib-treated population). Almost 6% of VeriStrat-good patients were long-term responders, versus only 1.5% of VeriStrat-poor patients.
In a second study, previously treated patients with advanced NSCLC (both squamous and non-squamous histology) were enrolled in a single-institution translational research study.3 Patients in the study were treated with nivolumab, an anti-PD-1 agent, and serum samples were evaluated with both an investigational test developed for use in melanoma, and with VeriStrat testing. Both tests were shown to be prognostic in patients treated with nivolumab, with the investigational test having superior performance.
David Brunel, Biodesix.
“Immunotherapies are rapidly changing the treatment landscape in lung cancer, with significant benefit to patients,” says David Brunel, chief executive officer of Biodesix. “Developing the right tools to help physicians stratify patients to the appropriate therapies during the course of their treatment will be critical to extending survival, managing side effects, and controlling costs.
“Our testing methodology—which measures hundreds of proteins in a single assay and then utilizes the machine learning intelligence of our Diagnostic Cortex—is uniquely suited to characterizing different immune states and tumor immune escape strategies over time, with the goal of enabling physicians to provide advanced precision medicine,” adds Brunel. “Our work presented at the Society for Immunotherapy in Cancer and at the World Lung Cancer Conference is indicative of where we are headed with our research, and value we intend to bring to treating patients.”
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REFERENCES
- Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomized controlled phase 3 trial. Lancet Oncol. 2015;16(8):897–907; doi: 10.1016/S1470-2045(15)00006-6.
- Goss G, Cobo M, Lu S, et al. Second-line afatinib for advanced squamous cell carcinoma of the lung: analysis of afatinib long-term responders in the phase III LUX-Lung 8 trial. Presented at the 2016 World Conference on Lung Cancer (Vienna, Austria: 4–7 December 2016). Available at: www.biodesix.com/wp-content/uploads/2016/12/wclc_goss-ll8-ltrs_oral_24nov2016.pdf. Accessed December 26, 2016.
- Grossi F, Rijavec E, Biello F, et al. “Evaluation of pretreatment serum tests for nivolumab benefit in patients with non-small cell lung cancer.” Poster presented at the 2016 World Conference on Lung Cancer (Vienna, Austria: 4–7 December 2016). Available at: www.biodesix.com/wp-content/uploads/2016/12/wclc2016_grossi_-nivo_bdx008_final3.pdf. Accessed December 26, 2016.
