121O RATIONALE 309: A randomized, global, double-blind, phase III trial of tislelizumab (TIS) vs placebo, plus gemcitabine + cisplatin (GP), as first-line treatment for recurrent/metastatic nasopharyngeal cancer (RM-NPC)

TIS is an anti-PD-1 antibody engineered to minimize FcγR binding, a mechanism of T-cell clearance and potential anti-PD-1 resistance. TIS demonstrated antitumor activity in NPC as a single agent in a Phase I/II study (CTR20160872). This randomized, double-blind, Phase III study evaluated TIS + GP vs placebo + GP as 1L treatment for RM-NPC (NCT03924986).