NIRA-05 THE EFFECT OF CLINICAL DATA ON MODIFYING RADIOLOGY ASSESSMENTS IN PIVOTAL ONCOLOGY TRIALS, USING THE RESPONSE ASSESSMENT IN NEURO-ONCOLOGY FOR BRAIN METASTASIS (RANO-BM) CRITERIA.

Abstract We analyzed Blinded Independent Central Review (BICR) outcomes for 130 patients enrolled in pivotal oncology trials, using the Response Assessment in Neuro-Oncology for brain metastasis (RANO-BM) criteria. Neuroradiologists reviewed anatomical imaging across multiple time points, and surrogate endpoint data were derived from these assessments. Radiology findings were then integrated with oncologists’ clinical profiles to determine overall patient outcomes. These clinical profiles included corticosteroid and clinical status data. This analysis compared per-subject radiology assessments with the final comprehensive evaluations to assess the impact of clinical review. Preliminary data indicated that clinical review modified radiology outcomes for eight (8) patients (6.1%). In seven (7) cases, a progression event not captured by radiology alone was identified clinically. For five (5) patients, the Radiology Best Response was revised—downgrades included changes from Partial Response (PR) to Stable Disease (SD) or Progressive Disease (PD) or reclassification of a non-evaluable (NE) result to PD. RECIST, as modified for CNS evaluations, does not account for corticosteroid use or clinical status. This analysis underscores the impact of incorporating clinical data into brain metastasis assessments, as it may lead to outcomes that differ between RANO-BM and modified RECIST CNS criteria evaluations.