Biodesix Inc, Boulder, Colo, has 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.1
“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,” says Richard Hockett, chief medical officer at Biodesix. “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. Development of the test was performed using pretreatment serum samples from 119 patients from a nivolumab clinical trial, and was independently validated on pretreatment serum of 30 patients from a nonprotocol 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 nonprotocol study classified as having a high likelihood of good outcome had a 74% 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% lower risk of disease progression (HR 0.50, p=0.001) and a 62% lower risk of death (HR 0.38, p=0.001) compared to those with a profile predicting low likelihood of good outcome.
“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,” says Heinrich Roder, chief technology officer at Biodesix. “While further validation studies are needed, this test has the potential to become a clinically useful tool for guiding anti-PD1 therapy.”
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.
For more information, visit Biodesix.
- Weber J, Martinez A, Roder H, et al. Pretreatment patient selection for nivolumab benefit based on serum mass spectra [poster presentation]. National Harbor, Md: Society for Immunotherapy of Cancer annual meeting, November 4–8, 2015.