Avelumab treatment of metastatic urothelial carcinoma (mUC) in the phase 1b JAVELIN solid Tumor study: updated analysis with ≥6 months of follow-up in all patients

Abstract

Background: Avelumab, a human anti-PD-L1 monoclonal antibody, has shown promising efficacy and safety in patients (pts) with mUC. We report an updated analysis of avelumab treatment in 2 cohorts of pts from JAVELIN Solid Tumor (NCT01772004). Methods: Pts with mUC whose disease had progressed after platinum-based therapy or were cisplatin ineligible received avelumab 10 mg/kg Q2W. Tumors were assessed every 6 weeks by independent review (RECIST v1.1). Endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety (NCI CTCAE v4.0), and tumor PD-L1 expression. Kaplan-Meier (K-M) method was used to estimate DOR, PFS, and OS. Results: As of Sep 2016, 249 pts had received avelumab and were followed for