The manuscript describes the company's progress in identifying predictive dynamic biomarkers to help identify the subset of patients with head and neck/esophageal squamous cell carcinoma who may benefit from treatment with cetuximab (Erbitux) and biosimilars.
Cetuximab is an antibody that targets an epidermal growth factor receptor, and remains the only targeted therapy approved by the US Food and Drug Administration for SCC of head and neck/esophagus.
For primary SCC, cetuximab is approved for use in combination with radiation. In metastatic SCC, it is approved for use in combination with platinum chemotherapy and fluorouracil.
The authors note that responses to cetuximab can be dramatic, but the response rate was only about 15% in the landmark clinical trial.
The authors also note that cetuximab therapy is accompanied by a risk of serious adverse events that results in interrupted therapy in 3%-10% of patients. The cost of treatment is approximately USD 100,000 per patient. Additionally, immune checkpoint inhibitors are now an option in SCC.
Therefore, methods to identify patients who are most likely to respond to cetuximab are needed.
SCC is the world's sixth most common cancer. Worldwide, there are approximately 900,000 new cases and 450,000 deaths per year.
In the United States alone there are approximately 66,630 new cases and 14,620 deaths per year.
The research described in the manuscript discussed here was supported by a Small Business Innovation Research award from the National Cancer Institute of the National Institutes of Health.
BioMarker Strategies has developed SnapPath, the only cancer diagnostics system that automates and standardizes functional ex vivo profiling of live solid tumor cells from fresh biopsies or other fresh, unfixed samples such as patient-derived xenografts.
SnapPath can help guide cancer drug development and treatment selection. SnapPath is unique in automating and standardizing functional profiling of live solid tumor cells from fresh, unfixed tissue samples and enables the generation of PathMAP Functional Signaling Profiles.
PathMAP Functional Signaling Profiles, such as the studies describe here, represent a new class of biomarker tests, which are based on the dynamic and predictive signaling information available only from live cells.
They are useful in identifying and understanding mechanisms of acquired resistance, and they are highly predictive of individual tumor response to targeted therapies.
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