Investigational Blood Test Identifies Patients with Melanoma Who Are More Likely to Have Improved Survival on Nivolumab Therapy; Biodesix’ blood test is independent of PD-L1 expression
Biodesix, Inc. today announced new clinical findings showing that its novel investigational test, BDX008, based on profiling serum proteins, identifies patients with advanced melanoma who are more likely to have longer progression-free and overall survival with nivolumab therapy. Early data suggesting the test’s clinical potential for guiding anti-PD-1 therapy is being presented at the 30th annual meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, MD.
“As the range of treatment options available to cancer patients continues to expand—including immunotherapy—diagnostics are increasingly important to ensure that patients receive the regimens that are most likely to provide clinical benefit,” said Dr. Richard Hockett, Biodesix’ Chief Medical Officer. “The results of this study are particularly exciting, as they suggest that we may be able to identify patients most likely to benefit from anti-PD-1 therapies.”
Biodesix developed BDX008 based on patient serum samples collected before beginning PD-1 blockade therapy for advanced, unresectable melanoma. The development of the test was done on pre-treatment serum samples from 119 patients from a nivolumab clinical trial (NCT01176461) and independently validated on pre-treatment serum on 30 patients from a non-protocol study using PD-1 blockade regimens. Patients were followed during and after therapy to determine overall survival. Additionally, patients in the nivolumab study were followed to determine time to disease progression.
The evaluation showed that patients in the non-protocol study classified as having a high likelihood of good outcome had a 74 percent lower risk of death compared to those with a profile associated with low likelihood of good outcome (hazard ratio [HR] 0.26, p=0.002). Of the 119 patients in the nivolumab trial, those with a profile predicting high likelihood of good outcome had a 50 percent lower risk of disease progression (HR 0.50, p=0.001) and a 62 percent lower risk of death (HR 0.38, p=0.001) compared to those with a profile predicting low likelihood of good outcome. The study collaborators include Drs. J. Weber and A. Martinez from Moffitt Cancer Center and Drs. A. Bacchiocchi, M. Sznol, R. Halaban, H. Kluger from Yale University.
“Interestingly, the low and high likelihood of benefit groups identified by this test did not show any association with the level of PD-L1 expression,  and the differences in survival remained significant after we controlled for multiple potentially confounding variables,” said Dr. Heinrich Roder, Chief Technology Officer, Biodesix. “While further validation studies are needed, this test has the potential to become a clinically useful tool for guiding anti-PD1 therapy.”
Biodesix’ diagnostic tests are used for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance, leading to improved outcomes for cancer patients. The company currently has two tests available to clinicians, GeneStrat™ and VeriStrat®. Used for tumor profiling, GeneStrat is a gene panel of clinically actionable mutations. VeriStrat, a serum proteomic test, provides physicians with prognostic and predictive information to improve treatment decisions. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve the utility of therapeutic agents.
 Weber J, Martinez A, Roder H, et al. Pre-treatment patient selection for nivolumab benefit based on serum mass spectra. Poster presentation at: 30th annual meeting of the Society for Immunotherapy of Cancer, November 4-8, 2015, National Harbor, MD.
 PD-L1 is a ligand produced by cells that binds to the PD-1 receptor on T-cells, inhibiting their activity.