Abstract CT011: Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304)

作者：Chaosu Hu, Xiaozhong Chen, Tingting Xu, Shuang Huang, Feng Liu, Song Qu, Lisha Chen, Ping Zhou, Shenhong Qu, Xiaohong Ai, Yong Chen, Meilian Liu, Rensheng Wang, Kelvin Chan, Peng Zhang, Chunhong Hu, Jiyu Wen, Jian Zhang, Qin Lin, Xiaojiang Li, Kangsheng Gu, Xiang Li, Dongxia Wang, Jingao Li, Daren Lin, Desheng Hu, Jian-Wu Ding, Siyang Wang, Xiao-Ming Huang, Lin Wang, Feng Jin, David G. Pfister, Milena Perez Mak, Pedro Rafael Martins De Marchi, Yi Jiang, Haihua Yang, Xiaoye Hu, Tianrun Liu, Dehua Wu, Aditya Shreenivas, Thiago Bueno de Oliveira, Carlos Eduardo Baston Silva, Gustavo Vasconcelos Alves, Xianming Li, Zhifang Yao, Dongmei Lu, Mingxiu Hu, Zhongmin Maxwell Wang, Baiyong Li, Michelle Xia · 发表于：Cancer Research · 年份：2025 · DOI：10.1158/1538-7445.am2025-ct011 · 被引用次数：7 · 研究领域：Head and Neck Cancer Studies、Lung Cancer Research Studies、Cancer Research and Treatments

Abstract Background: Studies have shown that the combination of PD-1 inhibitors with chemotherapy exhibits promising efficacy as a first-line treatment for Asian patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). This presentation reports the results of a global phase 3 clinical trial with ethnically diverse patients treated with penpulimab plus chemotherapy vs. placebo plus chemotherapy as the first-line therapy for R/M NPC (NCT04974398). Methods: AK105-304 trial was conducted across 46 sites worldwide. Participants aged 18-75 years with previously non-systemically treated R/M NPC, stratified by disease stages (de novo metastases vs. recurrent), ECOG (0 vs. 1), liver metastasis (present vs. absent), were randomized (1:1) to receive penpulimab or placebo (200mg, Day1) in combination with gemcitabine (1000mg/m2, Day 1 and 8) and cisplatin (80mg/m2, Day1) or carboplatin (AUC5, Day1) every 3 weeks (Q3W) for up to 6 cycles, followed by maintenance therapy with penpulimab or placebo (200mg, Q3W). Placebo-arm patients were allowed to crossover to receive penpulimab monotherapy (200 mg, Q3W) upon confirmed disease progression by blinded independent center review (BICR). Primary endpoint was PFS assessed by BICR, and key secondary endpoint was OS. Other secondary endpoints included ORR, DoR and safety. Results: 291 patients were randomized to penpulimab arm (n=144) or placebo arm (n=147). Baseline characteristics were generally balanced between treatment arms. ...