ABSTRACT

Immunotherapy has emerged as one of the most promising approaches to treat patients with cancer. Recently, the entire medical oncology field has been revolutionized by the introduction of inhibitors of immune checkpoint blockers. Despite demonstrated successes in a variety of malignancies, responses typically occur in only a small percentage of patients in any given histology and treatment regimen. There is a concern that immunotherapies are associated with immune-related toxicity and have high cost. Therefore, using biomarkers to determine which patients would derive clinical benefit from which immunotherapy, and/or be susceptible to adverse side effects, is a compelling clinical and social question. The opportunity to design parallel biomarkers studies inside the most important randomized clinical trials could be the ideal solution to stratify patients and select the right population for clinical efficacy testing. Sample collection at specific points of treatment is important for evaluating possible biomarkers and studying the mechanisms of responsiveness, resistance, toxicity and relapse.

Collaborative networks have a critical need to achieve a “fingerprint” for each patient in order for that patient to be eligible, ad hoc, for highly granted immunotherapy treatments, and new biomarkers are needed to improve the possibility of narrowing the best effective immunotherapy. The pre-analytical and analytical aspects, as well as clinical validation and regulatory considerations, are mandatory for immune biomarker development.