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 EGFR-TKI therapy

BOULDER, Colo., October 5, 2016 – New clinical findings show that the Biodesix^® VeriStrat test identifies patients with squamous cell carcinoma of the lung who are more likely to have longer progression-free and overall survival (PFS and OS) with irreversible ErbB family blocker afatinib therapy over erlotinib, a reversible EGFR tyrosine kinase inhibitor (TKI). Retrospective clinical trial data suggesting the test’s clinical potential for guiding EGFR-TKI therapy are being presented at the Annual Meeting of the European Society for Medical Oncology (ESMO) in Copenhagen, Denmark (Abstract #1238P – Poster Display, Saturday 8 October, 13:00 – 14:00 CEST).

“For patients with advanced squamous cell carcinoma of the lung who have “good” status according to the VeriStrat test, EGFR-TKI therapy remains a relevant option, in addition to the recently approved checkpoint inhibitors for this patient population,” said Dr. Dr. Glenwood D. Goss, Professor of Medicine of the University of Ottawa. “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 OS of 11.5 months versus 8.9 months. 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. While further validation studies are needed, the VeriStrat test has the potential to be clinically useful for guiding TKI therapy in squamous NSCLC.”

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.¹ VeriStrat test results are available to ordering physicians within 72 hours.

Study Results
In the LUX Lung-8 clinical trial that compared afatinib vs. erlotinib in squamous cell carcinoma, VS-G patients had longer overall survival and progression-free survival than VS-P patients in both the afatinib and erlotinib arms, which is consistent with several previous erlotinib studies.² When compared across therapies by VeriStrat status, the VS-G group’s median OS and PFS were significantly better for afatinib than 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.³ 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 LUX-Lung 8 study was sponsored by Boehringer Ingelheim and collaborators include Dr. Glenwood D. Goss of the University of Ottawa and Dr. Jean Charles Soria from Gustave Roussy Cancer Campus and University Paris-Sud.

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. Gregorc, Vanesa et al. "Predictive Value Of A Proteomic Signature In Patients With Non-Small-Cell Lung Cancer Treated With Second-Line Erlotinib Or Chemotherapy (PROSE): A Biomarker-Stratified, Randomised Phase 3 Trial". The Lancet Oncology 15.7 (2014): 713-721.

2. Biodesix internal data.

3. For statistical details please see the Poster abstract: https://www.biodesix.com/esmo-european-society-medical-oncology-oct-7-11-copenhagen-denmark/