Combination of Tim-3 blockade TQB2618 with penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): A multicenter, single-arm, two-cohort, phase 2 study.

作者：Cheng Xu, Qingqing Cai, Jun Ma, Kunyu Yang, Siyang Wang, Liangfang Shen, Song Qu, Jing Huang, Xinqiong Huang, Ling Tang, Yingpeng Peng, Yi Xia, Liangliang Shi, Fan Zhang, Jianming Gao, Yan‐Ping Mao, Rui Guo, Xiaohua Hong, Zhanjie Zhang, Ying Sun · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.6031 · 被引用次数：3 · 研究领域：Peptidase Inhibition and Analysis、Cancer-related gene regulation、Ubiquitin and proteasome pathways

6031 Background: T cell immunoglobulin and mucin domain molecule 3 (Tim-3) is an inhibitory immune checkpoint receptor that negatively regulates the immune response. This multicenter, single-arm, two-cohort, phase 2 study (NCT05563480) aimed to explore the efficacy and safety of TQB2618, a novel monoclonal antibody blockading Tim-3, plus PD-1 blockade penpulimab as subsequent-line treatment in immunotherapy-resistant R/M NPC (cohort 1) or as first-line treatment by incorporating into chemotherapy in treatment-naïve R/M NPC (cohort 2). Here, we report the results of cohort 2. Methods: Eligible pts were ECOG PS 0–1, aged 18–70, diagnosed with histologically confirmed R/M NPC with ≥ 1 measurable lesion. Previous systemic treatment was not allowed, except as a part of curatively intended treatment for locoregionally advanced NPC and develop disease progression at least 6 months after last dose. TQB2618 and penpulimab were administered intravenously at doses of 1200 mg and 200 mg, respectively, on the first day of a 21-day cycle until disease progression or unacceptable toxicity while gemcitabine (1000 mg/m 2 , d1&8) and cisplatin (75mg/m 2 , d1) were given intravenously for the first 4–6 cycles. The primary endpoint is progression-free survival (PFS). Results: Between February 2023 and October 2023, 30 pts were enrolled (median [range] age, 52 [33–70] years; 16.7% women). Seventeen were diagnosed with metastatic disease at the first visit and others developed disease recurren...