Phase 2 study to evaluate safety and efficacy of MEDI4736 (durvalumab [DUR]) in glioblastoma (GBM) patients: An update.

2042Background: DUR is a human IgG1 monoclonal Ab against PD-L1. PD-1/PD-L1 blockade has shown benefit in solid tumors. PD-L1 is expressed by many GBM tumors while cytotoxic lymphocytes infiltrating GBM tumors often express PD-1; thus, there is a rationale for exploring PD-1/PD-L1 blockade in GBM. Bevacizumab (BEV) is a VEGF-specific angiogenesis inhibitor approved for recurrent GBM. PD-L1 blockade and angiogenesis inhibition may be synergistic. Methods: This ongoing Phase 2, multicenter, open-label study (NCT02336165) evaluates safety/efficacy of DUR (10 mg/kg every 2 wks) in 5 GBM cohorts. Secondary endpoints are safety/tolerability, median PFS/OS, overall response rate and quality of life measures. Exploratory endpoints: neurologic function and immunocorrelative biomarkers. Results: Enrollment as of 16 Dec 2016: Cohort A = 35, B = 31, B2 = 34, B3 = 34, and C = 20 pts. Enrollment is ongoing for Cohorts A and C. This is an update to the interim analysis that was reported for Cohort B (male: 83.9%; mean a...