Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced adrenocortical carcinoma from the JAVELIN solid tumor phase Ib trial: Safety and clinical activity.

Abstract

4516Background: Avelumab* is a fully human anti-PD-L1 IgG1 antibody under clinical investigation in multiple cancers. We report safety and clinical activity of single-agent avelumab in patients (pts) with metastatic adrenocortical carcinoma (mACC), a rare malignancy for which there are limited therapeutic options (NCT01772004). Methods: Pts with mACC who had progressed after platinum-based therapy and were unselected for PD-L1 expression were treated with avelumab at 10 mg/kg IV Q2W until progression, unacceptable toxicity, or withdrawal. Prior and ongoing treatment with mitotane was permitted. Tumors were assessed every 6 wks (RECIST 1.1). Objective response rate (ORR) and progression-free survival (PFS) were evaluated. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Results: As of Oct 23, 2015, 37 pts were treated with avelumab (median 8 wks [range 2-48]) and followed for a median of 13 wks (range 0-58). Median age was 50 y (range 23-71), ECOG PS was 0 (37.8%) or 1 (62.2%), and median number of prio...