Anti-programmed death-1 antibody SHR-1210 (S) combined with apatinib (A) for advanced hepatocellular carcinoma (HCC), gastric cancer (GC) or esophagogastric junction (EGJ) cancer refractory to standard therapy: A phase 1 trial.

4075Background: A phase 1 (P1) study to assess the safety and efficacy of combination of S, a fully human IgG4 monoclonal antibody against PD-1 with PD-L1/PD-L2 plus Apatinib (A), a VEGFR2 inhibitor in patients (pts) with advanced HCC, GC, EGJ cancer. Methods: In P 1a dose escalation, pts received A (125, 250, 500mg, QD, 5 pts per cohort) and S (200 mg, Q2W) until unacceptable toxicity, disease progression. In phase 1b cohort expansion, pts received A at recommended P2 dose (RP2D) + S (200 mg, Q2W). Response was evaluated by RECIST v1.1. Results: At the cut-off data (Feb. 2. 2018), 42 pts (P 1a, n = 15; P 1b, n = 27) were enrolled. Median prior lines of therapy in HCC and GC were 1 and 2, respectively. In P1a stage, 3 DLTs (all grade 3 pneumonia) were observed in A 500mg cohort. The RP2D was A 250mg + S. In P 1b stage, the median treatment duration was 19 wks (range, 2-57 wks). 19 pts (58%) had ≥ grade 3 treatment-related adverse events (TRAEs). The ≥10% grade 3 TRAEs were hypertension (18%), increased AS...