Treatment of Immune Checkpoint Inhibitor for Unresectable Biliary Cancer

Abstract

Since the approval of the anti-PD-1 antibody, nivolumab, for malignant melanoma in 2014, clinical development of immune checkpoint inhibitors (ICIs) has rapidly advanced, and the standard chemotherapy regimen has been successively replaced by ICI-based regimens. In biliary tract cancer, two phase III trials (TOPAZ-1 and KEYNOTE-966) demonstrated the efficacy of ICIs in combination with gemcitabine plus cisplatin (GC), and CG plus ICI has been established as the new standard chemotherapy regimen. On the other hand, management of immune-related adverse events (irAEs) is required when administering ICI-based regimen. Although the frequency of grade 3 or higher irAEs reported in phase III clinical trials is not high (<8%), the frequency of irAEs is expected to be higher in daily clinical practice, making the proper management of irAEs in ICI therapy clinically relevant.