ACTR-68. CONCORDANCE OF EGFR AND MGMT ANALYSES BETWEEN LOCAL AND CENTRAL LABORATORIES: IMPLICATIONS FOR CLINICAL TRIAL DESIGN AND PRECISION MEDICINE FOR DEPATUXIZUMAB-MAFODOTIN (ABT-414) IN GLIOBLASTOMA (GBM)

摘要

BACKGROUNDDepatuxizumab-mafodotin is an EGFR-directed monoclonal antibody that targets activated EGFR (wild type or EGFRvIII) conjugated to a microtubule inhibitor. EGFRamp correlated with recurrent GBM response in a phase I trial (M12-356, ), thus becoming a centrally determined inclusion criterion in an ensuing phase II/III randomized study for newly diagnosed disease now accruing (RTOG 3508, M13-813, ). Centrally detected EGFRvIII mutation and MGMT promoter methylation are also stratification factors in RTOG 3508 to balance randomization for biomarkers of potential predictive or prognostic significance. Allowing use of locally determined molecular profiling may reduce accrual barriers by avoiding added time of tissue shipping and repeat central testing. However, discordant results between local and central tests could confound interpretation of clinical trial results. Therefore, we compared local vs. central biomarker results among patients screened for M12-356 or RTOG 3508 at Columbia University Medical Center (CUMC).