Clinical findings have shown that the VeriStrat test from Biodesix, Boulder, Colo, is prognostic for outcomes among patients with squamous cell carcinoma of the lung who are treated with afatinib (Gilotrif), a therapy developed and marketed by Boehringer Ingelheim Pharmaceuticals Inc, ?Ingelheim?, Germany.1
The study involved a retrospective analysis of data from the Phase III LUX Lung 8 trial. Patients with VeriStrat-good (VS-G) classification had superior survival outcomes on afatinib compared to erlotinib.
“The present data clearly show that epidermal growth factor receptor–tyrosine kinase inhibitor (EGFR-TKI) therapy is useful for VeriStrat-good patients, and that afatinib confers significantly better survival than erlotinib, with median overall survival of 11.5 months versus 8.9 months for the VS-G patients,” says Glenwood D. Goss, professor of medicine at the University of Ottawa. “While further validation studies are needed, these survival data compare very favorably with other therapies that are currently available for the second-line treatment of patients with squamous cell carcinoma of the lung.”
“Using a diagnostic test such as VeriStrat can improve the likelihood that patients will receive optimal therapy,” says David Brunel, CEO of Biodesix. “While immunotherapies are the preferred standard of care in second line—and an increasingly important consideration in the first line—they only provide durable benefit in a subset of patients, and many patients progress. Based on this study, afatinib has greater activity in VS-G patients.”
In the Phase III LUX Lung 8 clinical trial that compared afatinib versus erlotinib treatment for squamous cell carcinoma, VS-G patients had longer overall survival (OS) and progression-free survival (PFS) than VeriStrat-poor (VS-P) patients in both treatment arms—a finding consistent with those of several previous erlotinib studies.
When compared across therapies, the VS-G group’s median OS and PFS were significantly better for afatinib as compared to erlotinib. Median OS was 11.5 months for afatinib and 8.9 months for erlotinib (HR 0.787 [0.632, 0.979 95% CI]; p=0.0312), while median PFS was 3.3 months for afatinib and 2.0 months for erlotinib.2
In the VS-P group, median OS and PFS were essentially equivalent. Median OS was 4.7 months for afatinib and 4.8 months for erlotinib, while median PFS was 1.9 months for both afatinib and erlotinib.
Multivariate analysis showed that VeriStrat was an independent predictor of OS and PFS among patients treated with afatinib, regardless of their performance status according to the Eastern Cooperative Oncology Group scale, best response to first-line therapy, age, or race.
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1. Gadgeel S, Goss G, Soria JC, et al. Evaluation of the VeriStrat serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the Phase III LUX Lung 8 study. Lung Cancer. 2017;109:101–108; doi: 10.1016/j.lungcan.2017.05.010.
2. Goss GD, Lee KH, Felip E, et al. Evaluation of VeriStrat, a serum proteomic test, in the randomized, open-label, Phase III LUX Lung 8 (LL8) trial of afatinib (A) versus erlotinib (E) for the second-line treatment of advanced squamous cell carcinoma (SCC) of the lung [presentation abstract]. Chicago: American Society of Clinical Oncology, 2016 Annual Meeting, June 3?7 2016. Available at: meetinglibrary.asco.org/record/123916/abstract.