This invention describes a technical advancement in human tissue digestion that allows for the successful profiling of tumor infiltrating lymphocytes (TILs) by flow cytometry. Using this digestion method, UCSF researchers were able to determine that patients with 30% or more TILs with high expression of biomarkers PD-1 and CTLA-4 are likely to respond to anti-PD-1 cancer immunotherapy.
The incidence of melanoma has increased 15 times in the last 40 years and accounts for the majority of skin cancer deaths. Consequently, it’s becoming increasingly important to rapidly determine the most effective treatment for this aggressive form of cancer. In recent years, immunotherapy has emerged as an effective treatment option for melanomas that don’t respond to prior treatment and has expanded to become a first-line treatment for unresectable or metastatic melanoma, however, only about 20% of patients respond to these treatments. Until now, there have been no methods that predict response to melanoma immunotherapy. UCSF researchers developed a tissue digestion protocol that allowed the profiling of TILs to predict melanoma patient response to anti-PD-1 therapy. This could eliminate time wasted on inappropriate treatment plans, expediting the use of an effective therapy and improving clinical outcomes.
This novel invention provides the following advantages:
Scientists at the University of California, San Francisco have identified biomarkers that can be used to predict melanoma’s responsiveness anti-PD-1 therapy. An advanced tissue digestion protocol allowed researchers to use flow cytometry to identify that TILs expressing high levels of CTLA-4 and PD-1 predict a clinical response to anti-PD-1 therapy with a positive predictive value of 82%. This tool will be highly valuable for clinicians to rapidly decide whether or not to proceed with anti-PD-1 immunotherapy therapy or an alternative treatment plan.
To develop and commercialize this technology as a tool for identifying anti-PD-1 responsive tumors.