Lung Cancer: VeriStrat® Test Identifies Patients with Squamous Cell Carcinoma of the Lung Who Are More Likely to Have Improved Survival on Afatinib Therapy

Biodesix’ blood-based VeriStrat test helps identify squamous NSCLC patients for afatinib therapy

Clinical findings published in the peer reviewed journal Lung Cancer show that the Biodesix^® VeriStrat test is prognostic for outcomes in patients with squamous cell carcinoma of the lung (SCC) who are treated with afatinib (Gilotrif^®), atherapy developed and marketed by Boehringer Ingelheim Pharmaceuticals, Inc. Patients with VeriStrat-Good (VS-G) classification had superior survival outcomes on afatinib compared to erlotinib. This study involved a retrospective analysis of the data from the Phase III LUX Lung 8 trial.

“The present data clearly show that 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. 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,” said Dr. Glenwood D. Goss, Professor of Medicine of the University of Ottawa.

“Using a diagnostic test such as VeriStrat can improve the likelihood that patients will receive optimal therapy,” said David Brunel, Biodesix CEO. “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 sub-set of patients and many patients progress. Based on this study, afatinib has greater activity in VS-G patients.”

In the LUX Lung-8 Phase III clinical trial that compared afatinib vs. erlotinib in squamous cell carcinoma, VS-G patients had longer overall survival and progression-free survival than VeriStrat-Poor (VS-P) patients in both treatment arms, which is consistent with several previous erlotinib studies.[1]  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. 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.[2] Multivariate analysis showed that VeriStrat was an independent predictor of OS and PFS in patients treated with afatinib, regardless of ECOG PS, best response to first-line therapy, age and race.

The VeriStrat^® Test                                              

Biodesix’ VeriStrat test is a predictive and prognostic blood-based proteomic test for patients with advanced non-small cell lung cancer. The test is used to assess disease aggressiveness by characterizing host response to the tumor, classifying patients as either VeriStrat-Good (VS-G) or VeriStrat-Poor (VS-P). The test has been shown to be predictive for EGFR targeted agents in second-line treatment, after progression on or after platinum based chemotherapy. VeriStrat test results are available to ordering physicians within 72 hours.

About Biodesix
Biodesix^® is a molecular diagnostics company advancing the development of innovative blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including the GeneStrat™ and VeriStrat^® tests that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.

[1] Biodesix internal data.

[2] Glenwood D Goss, et al. Evaluation of VeriStrat, a serum proteomic test, in the randomized, open-label, Phase 3 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. 2016 American Society of Clinical Oncology, 52^nd ASCO Annual Meeting; 3‒7 June 2016, Chicago, IL, USA (Publication)