Abstract
There is growing recognition that immunotherapy is likely to significantly improve health outcomes for cancer patients in the coming years. Currently, while a subset of patients experience substantial clinical benefit...
Highlights
Rapid advances in our understanding of the fundamental biology of cancer and the integral role of the immune response to tumor progression are changing drug development and clinical practice
We address the regulatory requirements for biomarkers by the U.S Food and Drug Administration (FDA), including in vitro diagnostic tests and companion diagnostics (CDx)
Many candidate biomarkers have been described to date, only three assays are FDA-approved to identify patients who are more likely to benefit from anti-PD-1/PD-L1 therapies
Summary
Rapid advances in our understanding of the fundamental biology of cancer and the integral role of the immune response to tumor progression are changing drug development and clinical practice. After the analytical validity of a biomarker assay is established, as described in Volume I, the test must be evaluated to assess its clinical performance both in predicting the clinical outcome of interest, i.e., clinical validation — as well as in resulting in patient outcomes improvement, i.e., clinical utility (Fig. 1).
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