Highlights
- •Pembrolizumab + eribulin showed clinical benefit in luminal metastatic breast cancer (BC).
- •Objective responses were achieved regardless of programmed death ligand 1 status.
- •Its safety profile is similar to eribulin or pembrolizumab monotherapy.
- •New predictive biomarkers are required in endocrine-resistant BC.
Abstract
Background
Pembrolizumab has modest activity if used in patients with hormone-receptor–positive
(HR+), HER2-negative, previously treated metastatic breast cancer (BC). Our study
investigated whether there would be any clinical benefit in combining chemotherapy
with pembrolizumab in a similar patient population.
Methods
This single-arm, phase Ⅱ trial enrolled women aged ≥18 years with HR+, HER2-negative,
inoperable, locally recurrent or metastatic BC. Patients were previously treated with
hormonal therapy and 1–2 chemotherapy regimens for locally recurrent and/or metastatic
BC. On each 21-day cycle, patients received intravenous pembrolizumab 200 mg on day
1 and eribulin 1∙23 mg/m2 on days 1 and 8. The primary endpoint was the clinical benefit rate. Analysis of
safety and activity was carried out in all patients who met the screening criteria
and received at least 1 dose of study treatment. The trial is registered at ClinicalTrials.gov,
NCT03222856.
Results
Of the 44 patients enrolled between January 29 and October 17, 2018, clinical benefit
was achieved in 25 (56∙8%, 95% confidence interval [CI]: 41∙0–71∙7), objective response in 18 (40∙9%, 95% CI: 26∙3–56∙8), median progression-free survival
was 6∙0 months (95% CI: 3∙7–8∙4), and 1-year overall survival was 59∙1% (95% CI: 45∙8–76∙2).
The most common treatment-emergent adverse events (AEs) of any grade were neutropenia
(20 [45∙5%]), anaemia (17 [38∙6%]), alopecia (19 [43∙2%]), asthenia (19 [43∙2%]),
diarrhoea (14 [31∙8%]), fatigue (14 [31∙8%]), and peripheral neuropathy (12 [27∙3%]).
Serious AEs occurred in 14 (31∙8%) patients including febrile neutropenia (3 [6∙8%]),
neutropenia (2 [4∙5%]), fever (2 [4∙5%]) and peripheral neuropathy (2 [4∙5%]). Immune-related
AEs occurred in 11 (25∙0%) patients. One (2∙3%) patient died of cardiac arrest unrelated
to study treatment.
Conclusion
Pembrolizumab plus eribulin demonstrates encouraging antitumour activity in patients
with heavily pre-treated, HR+, HER2-negative, locally recurrent or metastatic BC.
The safety and tolerability of the combination is similar to eribulin or pembrolizumab
monotherapy.
Keywords
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Article info
Publication history
Published online: March 29, 2021
Accepted:
February 3,
2021
Received in revised form:
February 1,
2021
Received:
January 22,
2021
Footnotes
☆The data were presented in part as a poster presentation entitled ‘A phase II study of pembrolizumab and eribulin in patients with HR-positive/HER2-negative metastatic breast cancer previously treated with anthracyclines and taxanes (KELLY study) (abstract ID 1689)’ at The San Antonio Breast Cancer Symposium 2019 (December 10–14, 2019. San Antonio, Texas, USA).
Identification
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