Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.

作者：Yuankai Shi, Haiqiang Mai, Chuanben Chen, Ying Wang, Jingao Li, Hekun Jin, Xingchen Peng, Peng Zhang, Shenhong Qu, Jian-Li Huang, Yu-Xiang He, Dongping Chen, Suming Pan, Jinsheng Hong, Ning Zhang, Feng Lei, Desheng Hu, Yan Qing, Xiaoping Jin, Junyou Ge · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.6004 · 被引用次数：4 · 研究领域：Lung Cancer Treatments and Mutations、Head and Neck Cancer Studies、Lung Cancer Research Studies

6004 Background: The addition of PD-1 inhibitor to gemcitabine and cisplatin (GP) showed promising activity as first-line therapy for R/M NPC. Here, we first report the PD-L1 inhibitor Tagitanlimab (KL-A167) plus GP compared with placebo plus GP in a randomized phase 3 study (KL167-Ⅲ-08, NCT05294172). Methods: Eligible patients (pts) with previously untreated R/M NPC were in 2:1 ratio randomly assigned to receive tagitanlimab or placebo (1200 mg, D1) in combination with cisplatin (80 mg/m 2 , D1) and gemcitabine (1000 mg/m 2 , D1 and D8) every 3 weeks (Q3W) for up to 6 cycles followed by tagitanlimab or placebo monotherapy Q3W until disease progression, unacceptable toxicity, or withdrawal of consent. After disease progression, pts from the placebo arm could crossover to receive tagitanlimab monotherapy. The primary endpoint was progression-free survival (PFS) assessed by the blinded independent central review (BICR) according to RECIST version 1.1. Results: Between Jun 16, 2022, and May 27, 2023, 295 pts were assigned to tagitanlimab plus GP arm (n = 197) or placebo plus GP arm (n = 98). The median age was 52 years, and 79.7% were male. As of Feb 4, 2024, 47.2% of pts in tagitanlimab plus GP arm vs 23.5% of pts in placebo plus GP arm were still on treatment, 36.7% of pts in placebo plus GP arm were crossed to receive tagitanlimab monotherapy after disease progression. The median follow-up time was 11.7 months. The PFS per BICR was met at the prespecified interim analysis wit...