Phase I study with pegylated human IL-10 (AM0010) alone or in combination with anti-PD-1 or FOLFOX-immune biomarker update.

157Background: Persistence of activated CD8 T cells is essential for the durability of tumor immune responses. IL-10 is an anti-inflammatory cytokine, PEGylated IL-10 (AM0010) enhances tumor specific CD8 T cell expansion and cytotoxicity. We evaluated tolerability and efficacy of AM0010 alone, with chemotherapy or anti-PD-1 in a phase 1 study. AM0010 alone induces objective anti-tumor responses without auto-immune toxicities. AM0010 with anti-PD-1 was evaluated in RCC (n=8) or NSCLC (n=5) and showed improved response rates (ORR 50 and 40% respectively) compared to published ORR with anti-PD-1 monotherapy. AM0010 and FOLFOX for 2nd LOT pancreatic cancer increased the ORR compared to FOLFOX. Expansion cohorts for AM0010 and FOLFOX in pancreatic cancer (n=20) or with anti-PD-1 in RCC (n=30) or NSCLC (n=30) were evaluated. Methods: Observed tumor responses were monitored using irRC criteria. Immune responses were analysed for 96 serum cytokines. Activation of PBMC derived CD4 and CD8 T cells were analyzed by ...