Avelumab (Msb0010718c), An Anti-Pd-L1 Antibody, In Patients With Metastatic Or Locally Advanced Solid Tumors: Assessment Of Safety And Tolerability In A Phase I, Open-Label Expansion Study.

3044 Background: The programmed death-1 receptor (PD-1) and its ligand (PD-L1) are key therapeutic targets in the reactivation of the immune response against multiple cancers. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody currently being investigated in clinical trials. The primary objective of this phase I, open-label, parallel-group expansion study (NCT01772004) was to assess the safety and tolerability of avelumab in patients (pts) with metastatic or locally advanced solid tumors. Methods: Pts with advanced or metastatic disease (including NSCLC, gastric, ovarian, breast, and melanoma; ECOG PS 0-1 at trial entry) were treated with avelumab at 10 mg/kg Q2W until confirmed complete response (CR), progression, unacceptable toxicity, or withdrawal. Adverse events (AEs) were evaluated by CTCAE v4.0. Results: In total, 480 pts treated with avelumab were followed-up for at least 4 weeks (wks) by Nov 5, 2014 and assessed in this interim analysis (median age, 60 years [range 29-85]; ECOG PS ...