Emerging concepts in biomarker discovery; The US-Japan workshop on immunological molecular markers in oncology
Howard Streicher (CTEP, Bethesda, MD, USA) presented an overview of biomarkers useful for patient selection, eligibility, stratification and immune monitoring. CTEP sponsors more than 150 protocols each year across many types of new agents, so that this program is familiar with the need to prioritize trials selection using biomarkers. Biomarkers are important for 1) patient selection and stratification for the best therapy; 2) identification of the most suitable targets of therapy; 3) measurement of treatment effect; 4) identification of mechanisms of drug action; 5) measurement of disease status or disease burden and; 6) identification of surrogate early markers of long-term treatment benefit .
Examples of biomarkers predictive of immunotherapy efficacy (predictive classifiers) [4-7] are telomere length of adoptively transferred tumor infiltrating lymphocytes which is significantly correlated with likelihood of clinical response , serum levels of vascular endothelial growth factor (VEGF), which are negatively associated with response of patients with melanoma to high dose interleukin (IL)-2 administration  or K-ras mutations that predict ineffectiveness of cetuximab for the treatment of colorectal cancer . Recently, the European Organization for Research and Treatment of Cancer (EORTC) reported a signature derived from pre-treatment tumor profiling that is predictive of clinical response to GSK/MAGE-A3 immunotherapy of melanoma. The signature includes the expression of CCL5/RANTES, CCL11/Eotaxin, interferon (IFN)-γ, ICOS and CD20 [11,12].