Bibliographic Details
Title: |
Camrelizumab combined with apatinib in patients with first-line platinum-resistant or PD-1 inhibitor resistant recurrent/metastatic nasopharyngeal carcinoma: a single-arm, phase 2 trial |
Authors: |
Li Yuan, Guo-Dong Jia, Xiao-Fei Lv, Si-Yi Xie, Shan-Shan Guo, Da-Feng Lin, Li-Ting Liu, Dong-Hua Luo, Yi-Fu Li, Shen-Wen Deng, Ling Guo, Mu-Sheng Zeng, Xiu-Yu Cai, Sai-Lan Liu, Xue-Song Sun, Xiao-Yun Li, Su-Chen Li, Qiu-Yan Chen, Lin-Quan Tang, Hai-Qiang Mai |
Source: |
Nature Communications, Vol 14, Iss 1, Pp 1-17 (2023) |
Publisher Information: |
Nature Portfolio, 2023. |
Publication Year: |
2023 |
Collection: |
LCC:Science |
Subject Terms: |
Science |
More Details: |
Abstract Immunotherapy combined with antiangiogenic targeted therapy has improved the treatment of certain solid tumors, but effective regimens remain elusive for refractory recurrent/metastatic nasopharyngeal carcinoma (RM-NPC). We conducted a phase 2 trial to evaluate the safety and activity of camrelizumab plus apatinib in platinum-resistant (cohort 1, NCT04547088) and PD-1 inhibitor resistant NPC (cohort 2, NCT04548271). Here we report on the primary outcome of objective response rate (ORR) and secondary endpoints of safety, duration of response, disease control rate, progression-free survival, and overall survival. The primary endpoint of ORR was met for cohort 1 (65%, 95% CI, 49.6–80.4, n = 40) and cohort 2 (34.3%; 95% CI, 17.0–51.8, n = 32). Grade ≥ 3 treatment-related adverse events (TRAE) were reported in 47 (65.3%) of 72 patients. Results of our predefined exploratory investigation of predictive biomarkers show: B cell markers are the most differentially expressed genes in the tumors of responders versus non-responders in cohort 1 and that tertiary lymphoid structure is associated with higher ORR; Angiogenesis gene expression signatures are strongly associated with ORR in cohort 2. Camrelizumab plus apatinib combination effectiveness is associated with high expression of PD-L1, VEGF Receptor 2 and B-cell-related genes signatures. Camrelizumab plus apatinib shows promising efficacy with a measurable safety profile in RM-NPC patients. |
Document Type: |
article |
File Description: |
electronic resource |
Language: |
English |
ISSN: |
2041-1723 |
Relation: |
https://doaj.org/toc/2041-1723 |
DOI: |
10.1038/s41467-023-40402-x |
Access URL: |
https://doaj.org/article/27667fc2633a47359b998b866e9c4201 |
Accession Number: |
edsdoj.27667fc2633a47359b998b866e9c4201 |
Database: |
Directory of Open Access Journals |