On March 3, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported impactful data on the Primary Immune Response (PIR) test at the IASLC 2022 Targeted Therapies of Lung Cancer Meeting (Press release, Biodesix, MAR 3, 2022, View Source [SID1234609464]). In this body of work, the PIR test provided two classifications of PIR-Not Resistant and PIR-Resistant predictive of likely response to immune checkpoint inhibitors (ICIs). The data showed that the Biodesix PIR test was predictive for survival outcomes when tested at baseline (HR=2.36, p=0.02) or 3 weeks after ICI treatment initiation (HR=3.53, p=0.001). Furthermore, the data suggested that patients classified as PIR-Resistant were more likely to experience rapid onset of immune related adverse events (irAE) when treated with ICIs (HR=2.40, p=0.08).
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The PIR test is a serum-based proteomic assay that utilizes mass spectrometry and machine learning. The study, titled Serum Proteomics Analysis as a Potential Predictive Biomarker for Survival Outcomes and Immune-related Adverse Events in Non-Small Cell Lung Cancer Receiving Immune Checkpoint Inhibitors was authored by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, Evanston, Illinois, Myungwoo Nam, MD, Lincoln Medical and Mental Health Center, Bronx, New York, and Dong-Uk Lee, MD and Young Kwang Chae, MD, MPH, MBA from Northwestern University Feinberg School of Medicine, Chicago IL. The PIR test was validated on samples from patients receiving second-line nivolumab (Bristol Myers Squibb) and was shown to stratify patients based on their outcomes to immunotherapy.
"This data is meaningful for patients with non-small cell lung cancer who are being considered for treatment with ICIs. Immune Checkpoint inhibitor drugs have gained interest in oncology because of their ability to boost a person’s immune response against cancer cells. It was recently estimated that nearly half of US patients with cancer are eligible for ICI therapy, however only about 1 in 8 will respond," said Scott Hutton, CEO, Biodesix. "Developing tools that provide a better understanding of a patient’s likely overall outcome and adverse events prior to treatment with ICIs will be critical for both the physician and patient, which is the true benefit of the PIR test."
While the PIR test is not yet commercially available, it is being studied further in multiple ongoing clinical studies and is expected to launch commercially in 2023.