15 March 2019 - - US-based diagnostic company Biodesix has presented new data demonstrating that the VeriStrat testis predictive of outcomes for patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors in the first-line setting, even when adjusted for PD-L1 status. Study results were presented at a poster session of the Multidisciplinary Thoracic Cancers Symposium in San Diego, titled, "Real-World Performance of Blood-Based Proteomic Profiling in Immunotherapy Treatment in Advanced Stage NSCLC," the company said.

The prospectively designed observational study (NCT03289780) is currently enrolling NSCLC patients at 33 US sites and will follow patient outcomes for 18 months.

A pre-planned interim analysis was conducted with the first 1000 patients enrolled with at least 12 months follow-up.

Results for the subset of patients with advanced NSCLC treated with a front-line ICI, with or without chemotherapy (n = 85; all frontline therapies n = 419), suggest that incorporating the host immune response as part of the initial patient assessment provides clinically meaningful information when choosing a frontline therapy for NSCLC.

Immune checkpoint inhibitors have emerged as standard treatment for wild-type patients with NSCLC based on established superiority over chemotherapy in efficacy.

However, it is known that not all patients testing positive for PD-L1 respond to ICIs.

When patients were stratified by the VeriStrat blood-based host response proteomic test, the individuals identified as VeriStrat Poor (~25%) had significantly lower overall survival with any ICI based regimen, compared to individuals identified as VeriStrat Good (~75%), even when adjusted for PD-L1 status in a multi-variate analysis.

According to the presentation, the VeriStrat test is predictive of outcomes for all treatment regimens and lines of therapy, including immunotherapy, even when adjusted for PD-L1 status.

Patients with a VS Good result had significantly higher median OS compared to VS Poor patients on both immuno-monotherapy and immunotherapy in combination with chemotherapy.

Patients with a VS Poor result did not benefit from treatment with immunotherapy or the addition of immunotherapy to platinum-based therapy.

The VeriStrat test is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood serum or plasma of patients with NSCLC.

Test results assign a good (VS Good) or poor (VS Poor) classification to patient samples.

Multiple studies support that patients with a VS Good result have a better prognosis than patients with a VS Poor result, independent of current clinical prognostic indicators and treatment choice.

VeriStrat testing has been validated in more than 70 studies with more than 6,600 patients and is covered by Medicare and most private health insurers.

Biodesix is a lung cancer diagnostic company addressing the continuum of patient care from early diagnosis of lung nodules through late stage cancer.

The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics with the power of artificial intelligence.