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 and Erwei Song ()
Additional contact information
Jieqiong Liu: Sun Yat-sen University
Ying Wang: Sun Yat-sen University
Zhenluan Tian: Sun Yat-sen University
Ying Lin: First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
Hengyu Li: Changhai Hospital, Navy Medical University (Second Military Medical University)
Zhaowen Zhu: Sun Yat-sen University
Qiang Liu: Sun Yat-sen University
Shicheng Su: Sun Yat-sen University
Yinduo Zeng: Sun Yat-sen University
Weijuan Jia: Sun Yat-sen University
Yaping Yang: Sun Yat-sen University
Shengqiang Xu: YuceNeo, Shenzhen
Herui Yao: Sun Yat-sen University
Wen Jiang: MD Anderson Cancer Center
Erwei Song: Sun Yat-sen University

Nature Communications, 2022, vol. 13, issue 1, 1-10

Abstract: 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.

Date: 2022
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DOI: 10.1038/s41467-022-30569-0

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