Cofactor Genomics has announced the publication of clinical trial results for OncoPrism-HNSCC, an RNA-based assay designed to predict the response to immune checkpoint inhibitors (ICI) in patients with head and neck squamous cell carcinoma (HNSCC). The multicenter PREDAPT study (NCT04510129), published in the Journal for ImmunoTherapy of Cancer, demonstrates the clinical validity and utility of OncoPrism-HNSCC in guiding treatment decisions for this patient population.
The study compared OncoPrism-HNSCC's predictive capability with that of PD-L1 CPS and Tumor Mutational Burden (TMB), two commonly used biomarkers for immunotherapy response. Results indicated that OncoPrism-HNSCC significantly outperformed both, showing a 300% improvement in specificity over PD-L1 CPS and a 400% improvement in sensitivity over TMB in predicting patient benefit from ICI. These findings suggest that OncoPrism-HNSCC could help avoid overtreatment and improve outcomes for HNSCC patients.
Enhanced Specificity and Sensitivity
Traditional biomarkers like PD-L1 and TMB have limitations in accurately predicting immunotherapy response in HNSCC, leading to suboptimal treatment decisions. OncoPrism-HNSCC leverages RNA expression paired with machine learning to directly measure the body’s immune response to cancer, offering a more precise assessment. According to Dr. Eric Duncavage, MD, Medical Director at Cofactor Genomics, this technology represents an emerging category of diagnostic tools that can improve immunotherapy treatment response prediction.
Clinical and Economic Impact
The PREDAPT study involved patients from 17 healthcare systems treated with ICI, either as a single agent or in combination with chemotherapy. The results showed that OncoPrism-HNSCC significantly predicted disease control and progression-free survival. Beyond improved patient outcomes, the study suggests potential health economic benefits by ensuring more patients receive the most appropriate personalized treatment.
Expert Commentary
Dr. Douglas Adkins, MD, a head and neck oncologist and Professor of Medicine at Washington University School of Medicine, noted that "The OncoPrism assay provides a new and important tool to help clinicians decide about treatment options for their patients with recurrent or metastatic head and neck cancer."
About OncoPrism-HNSCC
OncoPrism-HNSCC is a CAP/CLIA-validated and Medicare-approved test developed by Cofactor Genomics. It utilizes Health Expression Models (HEMs), which analyze RNA expression data to provide a high-dimensional view of biology, disease, and therapy response. This approach aims to bridge the precision medicine gap by offering clinicians more specific and informative data for treatment decisions.
