Avelumab (Msb0010718c; Anti-Pd-L1) As A First-Line Treatment For Patients With Advanced Nsclc From The Javelin Solid Tumor Phase 1b Trial: Safety, Clinical Activity, And Pd-L1 Expression.

9036Background: Avelumab* is a fully human anti-PD-L1 IgG1 antibody under clinical investigation in multiple cancers. We report safety and clinical activity of avelumab as 1st-line therapy in patients (pts) with non-small-cell lung cancer (NSCLC) from a phase 1b trial (NCT01772004). Methods: Pts with advanced NSCLC not previously treated systemically for metastatic or recurrent disease, without an activating EGFR mutation or ALK rearrangement, and not selected for PD-L1 expression were treated with avelumab 10 mg/kg IV Q2W until progression, unacceptable toxicity, or withdrawal. Responses were evaluated every 6 wks (RECIST 1.1). Adverse events (AEs) were graded by NCI-CTCAE v4.0. PD-L1 expression was assessed by IHC. Results: As of Oct 23, 2015, 145 pts received avelumab (median 10 wks [range 2-30]) and were followed for a median duration of 13 wks (range 0-31). Median age was 70 y (range 41-90), ECOG PS was 0 (31.0%) or 1 (69.0%), and histology was adenocarcinoma (63.4%), squamous (26.9%), other (3.4%), ...