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Clinical Trial
. 2024 Oct 15;5(10):101779.
doi: 10.1016/j.xcrm.2024.101779.

A phase 2 trial of gemcitabine plus toripalimab for cisplatin-ineligible patients with recurrent or metastatic nasopharyngeal carcinoma

Xiong Zou  1 , Xi Ding  2 , Zheng-Kai Feng  2 , Yan-Feng Ouyang  1 , Hui-Feng Li  1 , Kai Wen  1 , Zhi-Qiang Wang  3 , You-Ping Liu  2 , Yong-Long Liu  1 , Wei-Jing Zhang  4 , Qi Yang  1 , Si-Yuan Chen  1 , Yu-Long Xie  1 , Ruo-Qi Xie  1 , Chao Lin  1 , Chen-Mei Gu  5 , Pei-Yu Huang  1 , Rui Sun  6 , Yi-Jun Hua  7 , Rui You  8 , Ming-Yuan Chen  9
Affiliations
Clinical Trial

A phase 2 trial of gemcitabine plus toripalimab for cisplatin-ineligible patients with recurrent or metastatic nasopharyngeal carcinoma

Xiong Zou et al. Cell Rep Med. .

Abstract

Cisplatin is a cornerstone chemotherapy for nasopharyngeal carcinoma (NPC); however, certain patients are ineligible for cisplatin-based regimens. This phase 2 trial (NCT04405622) evaluated the efficacy and safety of gemcitabine and toripalimab in previously untreated patients with recurrent or metastatic NPC who were either ineligible for cisplatin or had experienced severe adverse events from prior cisplatin-based treatments. Patients received gemcitabine (1,000 mg/m2) and toripalimab (240 mg) every three weeks for six cycles, followed by toripalimab monotherapy for up to two years. The primary endpoint was the incidence of grade ≥3 adverse events, while secondary endpoints included objective response rate (ORR) and overall survival (OS). Of 30 screened patients, 21 were enrolled. No treatment-related fatalities occurred, with the most frequent adverse events being headache and nausea. The ORR was 61.9%, coupled with a disease control rate of 100%. Overall, gemcitabine plus toripalimab demonstrated low toxicity and promising efficacy for this specific patient cohort.

Keywords: PD-1; cisplatin; first-line; gemcitabine; ineligible; nasopharyngeal carcinoma.

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Conflict of interest statement

Declaration of interests The authors declare no competing interests.

Figures

None
Graphical abstract
Figure 1
Figure 1
Profile of the study
Figure 2
Figure 2
Antitumor activity (A) Best percentage change from baseline in target lesion. The dashed line at −30% change represents the RECIST v1.1 cutoff to define the partial response or stable disease. (B) Treatment exposure and response duration.
Figure 3
Figure 3
Survival analysis Kaplan-Meier curves of PFS (A), DoR (B), and OS (C) NR, not reached; NE, not estimated.
See this image and copyright information in PMC

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