Related Experiment Video
Updated: Jun 9, 2025
Identifying PD-1/PD-L1 Inhibitors with Surface Plasmon Resonance Technology
Published on: May 2, 2025
PD-1 inhibitor sintilimab treated patients with metastatic triple-negative breast cancer
Yan Jia1,2,3, Jie Zhang1,2,3, Yehui Shi1,2,3
1Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Purpose:
Triple-negative breast cancer (TNBC) is a highly challenging subtype due to a unique tumor microenvironment. Several evidence (IMpassion130 trial and KEYNOTE-355 trial) supported the therapeutic effect of the immune checkpoint inhibitor in TNBC. However, the efficacy and safety of the PD-1 inhibitor sintilimab in breast cancer (BC) has not been well-investigated. So the real-world data on sintilimab-treated patients with metastatic BC were collected and analyzed in this study.
Methods:
The patients were eligible according to the requirements included: ages between 18 years and 75 years; recurrent or metastatic TNBC; measurable disease based on RECIST v1.1; no limitation on the prior systemic treatments; and ECOG performance status of 0-1. Patients received sintilimab 200 mg intravenously every 3 weeks until unacceptable toxicity or disease progression.
Results:
From 1 June 2019 to 1 October 2022, 40 female patients (median age, 55.5 years) with metastatic TNBC (mTNBC) were enrolled into the study. The median prior lines of systemic therapy for mTNBC was three (range, 1-8), with 60% of cases receiving at least three lines of therapy for metastatic disease. The visceral or brain metastasis was detected in 40.4% or 9.6% of patients, respectively. The median duration of response was 2.8 months (range, 0.7-21.0), and the median number of sintilimab doses administered was 4 (range, 1-30). The ORR and DCR were 22.5% and 72.5%, separately. The median PFS was 3.5 months (range, 1.4-21.0), with a 6-month PFS rate of 15.0% (6/40). The median OS was 52.5 months (range, 9.0-247.0) as of data cut-off. Common adverse effects were acceptable, and fatigue, skin rash, and pruritus were the frequent toxicity observed. Two cases of grade 3 curable adverse events were considered to be treatment-related. PD-L1-positive tumor was found in 40% cases (4/10) of mTNBC. Although statistical difference was not reached, the trend was obvious. Patients with PD-L1-positive tumor gained better treatment response, while the TMB-high carrier received more benefits of PFS and OS.
Conclusion:
In our study, preliminary evidence provided the anticancer activity and acceptable adverse effects of sintilimab administered every 3 weeks to pretreated patients with mTNBC. Sintilimab showed its efficacy and safety of immunotherapy for patients with advanced TNBC.
Insights
Sintilimab demonstrated anticancer activity and acceptable safety in pretreated patients with metastatic triple-negative breast cancer (TNBC). This study provides real-world data on sintilimab
Area of Science:
- Oncology
- Immunotherapy
- Breast Cancer Research
Background:
- Triple-negative breast cancer (TNBC) presents unique challenges due to its tumor microenvironment.
- Immune checkpoint inhibitors have shown therapeutic potential in TNBC, as evidenced by trials like IMpassion130 and KEYNOTE-355.
- The efficacy and safety of sintilimab, a PD-1 inhibitor, in breast cancer (BC) require further real-world investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of the PD-1 inhibitor sintilimab in patients with metastatic breast cancer (mBC).
- To analyze real-world data from patients with metastatic triple-negative breast cancer (mTNBC) treated with sintilimab.
Main Methods:
- Retrospective analysis of 40 female patients with mTNBC aged 18-75 years.
- Patients received sintilimab 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity.
- Eligibility criteria included measurable disease (RECIST v1.1) and ECOG performance status of 0-1, with no limitations on prior systemic treatments.
Main Results:
- The overall response rate (ORR) was 22.5% and the disease control rate (DCR) was 72.5%.
- Median progression-free survival (PFS) was 3.5 months, and median overall survival (OS) was 52.5 months.
- Common adverse effects included fatigue, skin rash, and pruritus; two cases of grade 3 adverse events were treatment-related. PD-L1 positivity and high tumor mutational burden (TMB) showed trends towards better outcomes.
Conclusions:
- Sintilimab demonstrated preliminary anticancer activity and an acceptable safety profile in pretreated patients with mTNBC.
- Real-world data suggest sintilimab is a viable immunotherapy option for advanced TNBC.
- Further research into PD-L1 status and TMB may refine treatment strategies for TNBC patients receiving sintilimab.
