A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Summary

This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Timeline

Start

2021-08-16

Primary completion

2026-02-23

Completion

2026-12-23

Outcome

Met primary endpoint

paper a significantly longer median PFS in the penpulimab arm versus the placebo arm (9.63 versus 7.00 months; hazard ratio 0.45, 95% CI: 0.33-0.62, P < 0.0001) PMID 41946687 ↗

Publications

• Huang S, Liu F, Qu S, Chen L, Zhou P, Qu S, Ai X, Chen Y, Liu M, Wang R, Chan KK, Zhang P, Hu C, Wen J, Zhang J, Lin Q, Li X, Gu K, Xiang L, Wang D, Li J, Lin D, Hu D, Ding J, Wang S, Huang X, Wang L, Jin F, Pfister DG, Mak MP, Marchi PRM, Jiang Y, Yang H, Hu X, Liu T, Wu D, Shreenivas A, Oliveira TB, Silva CEB, Alves GV, Li X, Yao Z, Lu D, Hu M, Wang ZM, Li B, Xia M, Chen X, Hu C, Xu T. Anti-PD-1 antibody penpulimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: a randomized, double-blind phase 3 study. Signal Transduct Target Ther. 2026 Apr 8;11(1):126. doi: 10.1038/s41392-026-02645-0.

Drugs

Indications