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

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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 ( 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.

Original languageEnglish
Article number113386
JournalEuropean Journal of Cancer
StatePublished - Dec 2023

Bibliographical note

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© 2023 The Authors


  • Advanced breast cancer
  • Clinical trial
  • Eribulin
  • Immune checkpoint inhibitors
  • Luminal breast cancer
  • Metastatic breast cancer
  • Nivolumab


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