4047 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. Here we present preliminary results from a phase Ib dose expansion study (NCT01943461) evaluating safety and clinical activity in a cohort of Japanese patients (pts) with advanced gastric cancer (GC). Methods: Pts with previously treated progressive GC, ECOG PS 0-1, received avelumab at 10 mg/kg, Q2W. Responses were assessed according to RECIST 1.1 and modified immune-related RECIST (irRECIST). Adverse events (AEs) were evaluated by CTCAE v4.0. Initial data from a prespecified analysis are reported here. A total of 20 pts in this expansion cohort were enrolled. Results: As of Oct 8, 2014, 11 pts were treated with avelumab. Pts were followed-up for at least 3 weeks (wks) and the median treatment duration was 9.9 wks (range 4-12). Median age was 69 years (range 38–76) and all pts had an ECOG-PS of 0 or 1, with a median of 3 prior lines (range 1–4) of therapy. Drug-related treatment-emergent AEs (TEAEs; all grades) occurred in 10/11 pts (90.9%). The most frequently observed treatment-related TEAEs ( > 1 case; all grade 1 or 2) were infusion-related reactions (IRRs) (3 pts, 27.3%), hyperthyroidism, and pruritus (2 pts each, 18.2%). There were no treatment discontinuations from AEs. One pt had grade 3 anemia; it was assessed as not drug-related. At data cutoff, 2 pts (18.2%) have come off study due to disease progression. Nine patients were still on treatment. To date, partial responses according to RECIST have been observed in 3 pts. Conclusions: Avelumab at 10 mg/kg Q2W can be safely administered in Japanese pts with heavily pretreated, metastatic GC. Additional studies to evaluate the efficacy of avelumab in Japanese pts with GC are planned and biomarkers from tumor tissue and blood samples including PD-L1 expression and soluble factors related to immune response will be evaluated. *Proposed INN. Clinical trial information: NCT01943461.
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Yamada et al. (2015) studied this question.