Boulder, Colo., December 20, 2017 – Findings published in the American Association for Cancer Research (AACR) peer-reviewed journal Cancer Immunology Research demonstrate that a test based on a protein signature associated with patient outcome in metastatic melanoma can effectively predict survival in patients receiving PD-1 blocking antibodies. The test, developed with Biodesix’s proprietary Diagnostic Cortex® machine learning platform, is based on mass spectrometry analysis of patient serum.
“Understanding the biology of immune-resistant patients is critical to providing those patients with optimal therapy,” said Dr. Jeffrey Weber, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at NYU-Langone, and lead author of the study. “While further validation in large, randomized studies is needed, this study suggests that a blood-based test could provide a basis for identifying melanoma patients who may be either sensitive or resistant to checkpoint inhibition and allow an appropriate therapeutic choice to be made for individual patients.”
“Adapting Gene Set Enrichment Analysis (GSEA) to protein data allowed identification of biological processes associated with test classifications,” said Heinrich Roder, Ph.D., Biodesix chief technical officer. “The information derived from protein set enrichment analysis could help develop treatments overcoming primary anti-PD-1 resistance by adding inhibition of complement activation, suppression of wound healing, or down-modulation of acute phase pathways by blocking IL6 and IL1. These data may indicate that similar resistance mechanisms might be at work in other tumor types and increase the likelihood that Biodesix can develop tests outside of melanoma.”
A recent study showed that a subset of around 30 percent of the previously treated, metastatic melanoma patients subsequently treated with the anti-PD1 nivolumab show durable responses and clinical benefit. However, immunotherapies such as PD-L1 blockers are relatively costly and associated with significant toxicities in some patients. Delivering treatment only to those patients most likely to benefit would result in elimination of unnecessary toxicity and health care savings for patients who would not benefit from anti-PD1 therapy, but might benefit from combination immunotherapy or other therapies.
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.
 Hodi FS, Kluger H, Sznol M, et al: Durable, long-term survival in previously treated patients with advanced melanoma (MEL) who received nivolumab (NIVO) monotherapy in a phase I trial Cancer Res 76, 2016 76 (suppl)