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Clinical activity of nivolumab in combination with eribulin in HER2-negative metastatic breast cancer: A phase IB/II study (KCSG BR18-16)

 Se Hyun Kim  ;  Seock-Ah Im  ;  Koung Jin Suh  ;  Kyung-Hun Lee  ;  Min Hwan Kim  ;  Joohyuk Sohn  ;  Yeon Hee Park  ;  Ji-Yeon Kim  ;  Jae Ho Jeong  ;  Kyoung Eun Lee  ;  In Sil Choi  ;  Kyong Hwa Park  ;  Hee-Jun Kim  ;  Eun Kyung Cho  ;  So Yeon Park  ;  Milim Kim  ;  Jee Hyun Kim 
 EUROPEAN JOURNAL OF CANCER, Vol.195 : 113386, 2023-12 
Journal Title
Issue Date
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols / adverse effects ; B7-H1 Antigen ; Breast Neoplasms* / pathology ; Female ; Humans ; Middle Aged ; Nivolumab / therapeutic use ; Receptor, ErbB-2 / metabolism ; Triple Negative Breast Neoplasms* / drug therapy
Advanced breast cancer ; Clinical trial ; Eribulin ; Immune checkpoint inhibitors ; Luminal breast cancer ; Metastatic breast cancer ; Nivolumab
Aim: We evaluated the efficacy and safety of nivolumab and eribulin combination therapy for metastatic breast cancer (BC) in Asian populations. Methods: In this parallel phase II study, adult patients with histologically confirmed recurrent/metastatic hormone receptor-positive/HER2-negative (HR+HER2-) or triple-negative BC (TNBC) were prospectively enroled from 10 academic hospitals in Korea (ClinicalTrials.gov Identifier: NCT04061863). They received nivolumab (360 mg) on day 1 plus eribulin (1.4 mg/m2) on days 1 and 8 every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was the investigator-assessed 6-month progression-free survival (PFS) rate in each subtype. Secondary endpoints included investigator-assessed objective response rate (ORR) as per Response Evaluation Criteria in Advanced Solid Tumors version 1.1, disease control rate, overall survival, and treatment toxicity. The association between PD-L1 expression and efficacy was investigated. Results: Forty-five patients with HR+HER2- BC and 45 with TNBC were enroled. Their median age was 51 (range, 31–71) years, and 74 (82.2%) received one or two prior treatments before enrolment. Six-month PFS was 47.2% and 25.1% in the HR+HER2- and TNBC cohorts, respectively. Median PFS was 5.6 (95% confidence interval [CI]: 5.3–7.4) and 3.0 (95% CI: 2.1–5.2) months in the HR+HER2- and TNBC groups, respectively. ORRs were 53.3% (complete response [CR]: 0, partial response [PR]: 24) and 28.9% (CR: 1, PR: 12). Patients with PD-L1+ tumours (PD-L1 expression ≥1%) and PD-L1- tumours (ORR 50% versus 53.8% in HR+HER2-, 30.8% versus 29.0% in TNBC) had similar ORRs. Neutropenia was the most common grade 3/4 adverse event; the most common immune-related adverse events (AEs) were grades 1/2 hypothyroidism and pruritus. Five patients discontinued therapy because of immune-related AEs. Conclusion: Nivolumab plus eribulin showed promising efficacy and tolerable safety in previously treated HER2- metastatic BC. Trial registration: NCT04061863 © 2023 The Authors
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Milim(김미림)
Kim, Min Hwan(김민환) ORCID logo https://orcid.org/0000-0002-1595-6342
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
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