Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: a single-arm phase 2 trial

被引:0
|
作者
Zhu, Yu-Chun [1 ]
Wei, Zhi-Gong [2 ,3 ]
Wang, Jing-Jing [2 ,3 ]
Pei, Yi-Yan [2 ,3 ]
Jin, Jing [2 ,3 ]
Li, Dong [4 ]
Li, Zhi-Hui [4 ]
Liu, Zhe-Ran [2 ,3 ]
Min, Yu [2 ,3 ]
Li, Rui-Dan [2 ,3 ]
Yang, Li [2 ,3 ]
Liu, Ji-Yan [2 ,3 ]
Wei, Qiang [1 ]
Peng, Xing-Chen [2 ,3 ]
机构
[1] Sichuan Univ, West China Hosp, Dept Urol, Chengdu, Peoples R China
[2] Sichuan Univ, West China Hosp, Canc Ctr, Dept Biotherapy, Chengdu, Peoples R China
[3] Sichuan Univ, West China Hosp, State Key Lab Biotherapy, Chengdu, Peoples R China
[4] Gen Hosp Western Theater Command, Dept Oncol, Chengdu, Peoples R China
关键词
2-STAGE DESIGNS; OPEN-LABEL; IMMUNOTHERAPY; MITOTANE;
D O I
10.1038/s41467-024-54661-9
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
Adrenocortical carcinoma (ACC) is a rare, aggressive malignancy with a poor prognosis. Therapeutic options for patients with advanced ACC who have failed standard treatments are limited. Single-agent immunotherapy as a second-line treatment has shown unsatisfactory clinical outcomes. This phase II trial (NCT04318730) evaluated the efficacy and safety of the PD-1 inhibitor camrelizumab combined with the VEGFR inhibitor apatinib in previously treated advanced ACC. The primary endpoint was objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. A total of 21 patients with advanced ACC received at least one dose of camrelizumab and apatinib. The ORR was 52% (95% CI, 30-74%), meeting the primary endpoint, and the disease control rate (DCR) was 95% (95% CI, 76-100%). The median PFS was 13.3 months (95% CI, 8.4-NE), and the median OS was 20.9 months (95% CI, 11.0-NE). The most common grade 3-4 treatment-related adverse events were alanine aminotransferase elevation, aspartate aminotransferase elevation, and lymphopenia. Predefined exploratory analyses indicated that patients with higher peripheral blood CXCR3 + CD8 + T cell abundance, lower immunosuppressive CD4 + T cell abundance, and higher overlap of clonotypes between tumor-infiltrating T cells and circulating T cells, were more likely to respond favorably to the combined therapy. Immune checkpoint inhibitors have shown some activity in patients with adrenocortical carcinoma (ACC), a rare aggressive malignancy with limited treatment options. Here the authors report the results of a phase 2 trial of camrelizumab (anti-PD1) plus apatinib (VEGFR inhibitor) for previously treated ACC.
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页数:11
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