NEW YORK – Addario Lung Cancer Medical Institute and Biodesix said on Monday that they will launch an observational, prospective trial evaluating the clinical utility of Biodesix's Primary Immune Response (PIR) test in identifying lung cancer patients most likely to benefit from immunotherapy.
Biodesix's serum-based proteomic test gauges a pre-treatment immune profile that has shown in retrospective studies to identify patients who are likely to respond well to anti-PD-1 therapy. Study researchers aim to enroll 390 treatment naïve, non-squamous, non-small cell lung cancer patients with high PD-L1-expressing tumors (in at least 50 percent of tumor cells) and treat them with immunotherapy with or without platinum-based chemotherapy. Enrollment will occur at leading cancer centers in the US.
The FDA has approved pembrolizumab in combination with carboplatin and pemetrexed as a treatment for PD-L1-high NSCLC patients who have rapidly progressive disease with pembrolizumab monotherapy, but not all patients in this subgroup may respond to this regimen. Biodesix's proteomic test, which combines mass spectrometry and machine learning to assess circulating proteins in blood, has shown to predict immunotherapy response independent of PD-L1 status.
"We know that immunotherapy by itself does not work for everyone," Biodesix CEO Scott Hutton said in a statement. "With the physical and financial toxicity associated with these therapies, a biomarker that can predict survival or early death would be critical in determining the best therapeutic regimen for lung cancer patients."