Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer

Jieqiong Liu; Ying Wang; Zhenluan Tian; Ying Lin; Hengyu Li; Zhaowen Zhu; Qiang Liu; Shicheng Su; Yinduo Zeng; Weijuan Jia; Yaping Yang; Shengqiang Xu; Herui Yao; Wen Jiang; Erwei Song

doi:10.1038/s41467-022-30569-0

Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer

Jieqiong Liu, Ying Wang, Zhenluan Tian, Ying Lin, Hengyu Li, Zhaowen Zhu, Qiang Liu, Shicheng Su, Yinduo Zeng, Weijuan Jia, Yaping Yang, Shengqiang Xu, Herui Yao, Wen Jiang, Erwei Song

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Abstract

In the later-line setting or for patients with PD-L1-negative tumors, immunotherapy-based regimens remain ineffective against advanced triple-negative breast cancer (TNBC). In this multicentered phase II trial (NCT04303741), 46 patients with pretreated advanced TNBC were enrolled to receive camrelizumab 200 mg (day 1), and apatinib 250 mg daily, plus eribulin 1.4 mg/m² (day 1 and 8) on a 21-day cycle until progression, or unacceptable toxicity. Primary endpoint was objective response rate (ORR) according to RECIST 1.1. Secondary endpoints included toxicities, disease control rate (DCR), clinical benefit rate, progression-free survival (PFS), and 1-year overall survival. With a median of 3 lines of prior chemotherapy in the advanced setting, 17.4% had received PD-1/PD-L1 blockade plus chemotherapy for advanced disease. The ORR was 37.0% (17/46, 95% CI 23.2–52.5). The DCR was 87.0% (40/46, 95% CI 73.7–95.1). Median PFS was 8.1 (95% CI 4.6–10.3) months. Tertiary lymphoid structure was associated with higher ORR. Patients with lower tumor PML or PLOD3 expression had favorable ORR and PFS. PD-L1 status was not associated with ORR/PFS. Grade 3/4 treatment-related adverse events occurred in 19 (41.3%) of 46 patients. Camrelizumab plus apatinib and eribulin shows promising efficacy with a measurable safety profile in patients with heavily pretreated advanced TNBC.

Original language	English (US)
Article number	3011
Journal	Nature communications
Volume	13
Issue number	1
DOIs	https://doi.org/10.1038/s41467-022-30569-0
State	Published - Dec 2022
Externally published	Yes

ASJC Scopus subject areas

Physics and Astronomy(all)
Chemistry(all)
Biochemistry, Genetics and Molecular Biology(all)

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Liu, J., Wang, Y., Tian, Z., Lin, Y., Li, H., Zhu, Z., Liu, Q., Su, S., Zeng, Y., Jia, W., Yang, Y., Xu, S., Yao, H., Jiang, W., & Song, E. (2022). Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nature communications, 13(1), [3011]. https://doi.org/10.1038/s41467-022-30569-0

Liu, J, Wang, Y, Tian, Z, Lin, Y, Li, H, Zhu, Z, Liu, Q, Su, S, Zeng, Y, Jia, W, Yang, Y, Xu, S, Yao, H, Jiang, W & Song, E 2022, 'Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer', Nature communications, vol. 13, no. 1, 3011. https://doi.org/10.1038/s41467-022-30569-0

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title = "Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer",

abstract = "In the later-line setting or for patients with PD-L1-negative tumors, immunotherapy-based regimens remain ineffective against advanced triple-negative breast cancer (TNBC). In this multicentered phase II trial (NCT04303741), 46 patients with pretreated advanced TNBC were enrolled to receive camrelizumab 200 mg (day 1), and apatinib 250 mg daily, plus eribulin 1.4 mg/m2 (day 1 and 8) on a 21-day cycle until progression, or unacceptable toxicity. Primary endpoint was objective response rate (ORR) according to RECIST 1.1. Secondary endpoints included toxicities, disease control rate (DCR), clinical benefit rate, progression-free survival (PFS), and 1-year overall survival. With a median of 3 lines of prior chemotherapy in the advanced setting, 17.4% had received PD-1/PD-L1 blockade plus chemotherapy for advanced disease. The ORR was 37.0% (17/46, 95% CI 23.2–52.5). The DCR was 87.0% (40/46, 95% CI 73.7–95.1). Median PFS was 8.1 (95% CI 4.6–10.3) months. Tertiary lymphoid structure was associated with higher ORR. Patients with lower tumor PML or PLOD3 expression had favorable ORR and PFS. PD-L1 status was not associated with ORR/PFS. Grade 3/4 treatment-related adverse events occurred in 19 (41.3%) of 46 patients. Camrelizumab plus apatinib and eribulin shows promising efficacy with a measurable safety profile in patients with heavily pretreated advanced TNBC.",

author = "Jieqiong Liu and Ying Wang and Zhenluan Tian and Ying Lin and Hengyu Li and Zhaowen Zhu and Qiang Liu and Shicheng Su and Yinduo Zeng and Weijuan Jia and Yaping Yang and Shengqiang Xu and Herui Yao and Wen Jiang and Erwei Song",

note = "Funding Information: We thank the patients and their families, nurses, trial coordinators, radiologists, and pathologists who participated in this trial. Jiangsu Hengrui Pharmaceuticals Co., Ltd. provided the study drug. We thank Prof. Vered Stearns for advice on trial design and helpful comments to the manuscript. This work was supported by grants from the Natural Science Foundation of China-81621004, 81720108029, 81930081, and 91940305 [Song], Natural Science Foundation of China-82072906 [Liu], Guangdong Science and Technology Department-2020B1212060018 and 2020B1212030004 [Song], Clinical Innovation Research Program of Bioland Laboratory-2018GZR0201004 [Song], Guangzhou Science Technology and Innovation Commission-201803040015 [Song], Bureau of Science and Technology of Guangzhou-20212200003 [Song], the Program for Guangdong Introducing Innovative and Entrepreneurial Teams-2019BT02Y198 [Song], Wu Jieping Medical Foundation-320.6750.2020-07-2 [Liu] and Natural Science Foundation of Guangdong Province-2022A1515012238 [Liu]. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1038/s41467-022-30569-0",

language = "English (US)",

volume = "13",

journal = "Nature Communications",

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T1 - Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer

AU - Liu, Jieqiong

AU - Wang, Ying

AU - Tian, Zhenluan

AU - Lin, Ying

AU - Li, Hengyu

AU - Zhu, Zhaowen

AU - Liu, Qiang

AU - Su, Shicheng

AU - Zeng, Yinduo

AU - Jia, Weijuan

AU - Yang, Yaping

AU - Xu, Shengqiang

AU - Yao, Herui

AU - Jiang, Wen

AU - Song, Erwei

N1 - Funding Information: We thank the patients and their families, nurses, trial coordinators, radiologists, and pathologists who participated in this trial. Jiangsu Hengrui Pharmaceuticals Co., Ltd. provided the study drug. We thank Prof. Vered Stearns for advice on trial design and helpful comments to the manuscript. This work was supported by grants from the Natural Science Foundation of China-81621004, 81720108029, 81930081, and 91940305 [Song], Natural Science Foundation of China-82072906 [Liu], Guangdong Science and Technology Department-2020B1212060018 and 2020B1212030004 [Song], Clinical Innovation Research Program of Bioland Laboratory-2018GZR0201004 [Song], Guangzhou Science Technology and Innovation Commission-201803040015 [Song], Bureau of Science and Technology of Guangzhou-20212200003 [Song], the Program for Guangdong Introducing Innovative and Entrepreneurial Teams-2019BT02Y198 [Song], Wu Jieping Medical Foundation-320.6750.2020-07-2 [Liu] and Natural Science Foundation of Guangdong Province-2022A1515012238 [Liu]. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - In the later-line setting or for patients with PD-L1-negative tumors, immunotherapy-based regimens remain ineffective against advanced triple-negative breast cancer (TNBC). In this multicentered phase II trial (NCT04303741), 46 patients with pretreated advanced TNBC were enrolled to receive camrelizumab 200 mg (day 1), and apatinib 250 mg daily, plus eribulin 1.4 mg/m2 (day 1 and 8) on a 21-day cycle until progression, or unacceptable toxicity. Primary endpoint was objective response rate (ORR) according to RECIST 1.1. Secondary endpoints included toxicities, disease control rate (DCR), clinical benefit rate, progression-free survival (PFS), and 1-year overall survival. With a median of 3 lines of prior chemotherapy in the advanced setting, 17.4% had received PD-1/PD-L1 blockade plus chemotherapy for advanced disease. The ORR was 37.0% (17/46, 95% CI 23.2–52.5). The DCR was 87.0% (40/46, 95% CI 73.7–95.1). Median PFS was 8.1 (95% CI 4.6–10.3) months. Tertiary lymphoid structure was associated with higher ORR. Patients with lower tumor PML or PLOD3 expression had favorable ORR and PFS. PD-L1 status was not associated with ORR/PFS. Grade 3/4 treatment-related adverse events occurred in 19 (41.3%) of 46 patients. Camrelizumab plus apatinib and eribulin shows promising efficacy with a measurable safety profile in patients with heavily pretreated advanced TNBC.

AB - In the later-line setting or for patients with PD-L1-negative tumors, immunotherapy-based regimens remain ineffective against advanced triple-negative breast cancer (TNBC). In this multicentered phase II trial (NCT04303741), 46 patients with pretreated advanced TNBC were enrolled to receive camrelizumab 200 mg (day 1), and apatinib 250 mg daily, plus eribulin 1.4 mg/m2 (day 1 and 8) on a 21-day cycle until progression, or unacceptable toxicity. Primary endpoint was objective response rate (ORR) according to RECIST 1.1. Secondary endpoints included toxicities, disease control rate (DCR), clinical benefit rate, progression-free survival (PFS), and 1-year overall survival. With a median of 3 lines of prior chemotherapy in the advanced setting, 17.4% had received PD-1/PD-L1 blockade plus chemotherapy for advanced disease. The ORR was 37.0% (17/46, 95% CI 23.2–52.5). The DCR was 87.0% (40/46, 95% CI 73.7–95.1). Median PFS was 8.1 (95% CI 4.6–10.3) months. Tertiary lymphoid structure was associated with higher ORR. Patients with lower tumor PML or PLOD3 expression had favorable ORR and PFS. PD-L1 status was not associated with ORR/PFS. Grade 3/4 treatment-related adverse events occurred in 19 (41.3%) of 46 patients. Camrelizumab plus apatinib and eribulin shows promising efficacy with a measurable safety profile in patients with heavily pretreated advanced TNBC.

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Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer

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