NEW YORK – The Addario Lung Cancer Medical Institute and Biodesix said on Wednesday that they have enrolled the first non-small cell lung cancer patient in a trial evaluating biomarkers predictive of response to immunotherapy using Biodesix's Primary Immune Response, or PIR, test.
The observational BEACON-Lung trial will involve approximately 390 patients with previously untreated, advanced NSCLC expressing PD-L1 in over 50 percent of tumor cells. These patients will receive either a PD-1 inhibitor or a combination of anti-PD-1 therapy and chemotherapy. Investigators will evaluate the utility of the serum-based proteomic PIR test to predict patients' overall survival and early progression based on their immune profiles.
The PIR biomarker analysis will be performed retrospectively using blood draws taken from patients at three time points during the trial: before treatment, at the start of the third treatment cycle, and at disease progression. Investigators will also evaluate patients' responses based on their PD-L1 expression status and alterations identified via next-generation sequencing.
"[Identifying] the best treatment course for an individual patient still requires the development of biomarkers, especially in the field of immunotherapy," Mary Jo Fidler of Rush Medical College, the BEACON-Lung study's principal investigator, said in a statement. "BEACON-Lung is a study that aims to address this current gap in biomarker development and treatment selection for advanced non-small cell lung cancer."
Biodesix is exploring the PIR test's ability to personalize immunotherapy in a variety of contexts. At the American Association for Cancer Research's annual meeting in April, researchers presented data from a study in which they used the test to explore the association between immunotherapy treatment and immune-related adverse events in NSCLC patients.