title: Biomarkers and correlative endpoints for immunotherapy trials.
abstract: Immunotherapies for lung cancer are reaching phase III clinical trial, but the ultimate success likely will depend on developing biomarkers to guide development and choosing patient populations most likely to benefit. Because the immune response to cancer involves multiple cell types and cytokines, some spatially and temporally separated, it is likely that multiple biomarkers will be required to fully characterize efficacy of the vaccine and predict eventual benefit. Peripheral blood markers of response, such as the ELISPOT assay and cytokine flow cytometry analyses of peripheral blood mononuclear cells following immunotherapy, remain the standard approach, but it is increasingly important to obtain tissue to study the immune response at the site of the tumor. Earlier clinical endpoints such as response rate and progression-free survival do not correlate with overall survival demonstrated for some immunotherapies, suggesting the need to develop other intermediary clinical endpoints. Insofar as all these biomarkers and surrogate endpoints are relevant in multiple malignancies, it may be possible to extrapolate findings to immunotherapy of lung cancer.
authors.affiliation: From the Duke University Medical Center, Durham, NC.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Morse
authors.forename: Takuya
authors.initials: T
authors.lastname: Osada
authors.forename: Amy
authors.initials: A
authors.lastname: Hobeika
authors.forename: Sandip
authors.initials: S
authors.lastname: Patel
authors.forename: H Kim
authors.initials: HK
authors.lastname: Lyerly
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood* / Q000235:genetics / Q000276:immunology; D002986:Clinical Trials as Topic / Q000379:methods*; D023381:Endpoint Determination; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D008175:Lung Neoplasms / Q000097:blood / Q000235:genetics / Q000276:immunology / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D011237:Predictive Value of Tests; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor