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Cited by 807Breast Cancer Treatment StudiesCancer Immunotherapy and BiomarkersAdvanced Breast Cancer Therapies

Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study

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Adams, S., Schmid, P., Rugo, H.S., Winer, E.P., Loirat, D., Awada, A., Cescon, D.W., Iwata, H. +13 more·2019·Annals of Oncology
DOI 10.1093/annonc/mdy517
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Abstract

BACKGROUND: Treatment options for previously treated metastatic triple-negative breast cancer (mTNBC) are limited. In cohort A of the phase II KEYNOTE-086 study, we evaluated pembrolizumab as second or later line of treatment for patients with mTNBC. PATIENTS AND METHODS: Eligible patients had centrally confirmed mTNBC, ≥1 systemic therapy for metastatic disease, prior treatment with anthracycline and taxane in any disease setting, and progression on or after the most recent therapy. Patients received pembrolizumab 200 mg intravenously every 3 weeks for up to 2 years. Primary end points were objective response rate in the total and PD-L1-positive populations, and safety. Secondary end points included duration of response, disease control rate (percentage of patients with complete or partial response or stable disease for ≥24 weeks), progression-free survival, and overall survival. RESULTS: All enrolled patients (N = 170) were women, 61.8% had PD-L1-positive tumors, and 43.5% had received ≥3 previous lines of therapy for metastatic disease. ORR (95% CI) was 5.3% (2.7-9.9) in the total and 5.7% (2.4-12.2) in the PD-L1-positive populations. Disease control rate (95% CI) was 7.6% (4.4-12.7) and 9.5% (5.1-16.8), respectively. Median duration of response was not reached in the total (range, 1.2+-21.5+) and in the PD-L1-positive (range, 6.3-21.5+) populations. Median PFS was 2.0 months (95% CI, 1.9-2.0), and the 6-month rate was 14.9%. Median OS was 9.0 months (95% CI, 7.6-11.2), and the 6-month rate was 69.1%. Treatment-related adverse events occurred in 103 (60.6%) patients, including 22 (12.9%) with grade 3 or 4 AEs. There were no deaths due to AEs. CONCLUSIONS: Pembrolizumab monotherapy demonstrated durable antitumor activity in a subset of patients with previously treated mTNBC and had a manageable safety profile. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02447003.

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  • A study using pembrolizumab monotherapy for TNBC reported a response rate of only 5.3%.

    “For example, a study using pembrolizumab monotherapy for TNBC reported a response rate of only 5.3% [85].”

    From Nanosensitizer-assisted sonodynamic therapy for breast cancer (2025) · cites this paper as [85]

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Authors
Adams, S., Schmid, P., Rugo, H. S., Winer, E. P., Loirat, D., Awada, A., Cescon, D. W., Iwata, H., Campone, M., Nanda, R., Hui, R., Curigliano, G., Toppmeyer, D., O’Shaughnessy, J., Loi, S., Paluch-Shimon, S., Tan, A. R., Card, D., Zhao, J., Karantza, V., & Cortés, J.
Affiliations
  • NYU Langone’s Laura and Isaac Perlmutter Cancer Center (US)
  • Queen Mary University of London (GB)
  • University of California, San Francisco (US)
  • Dana-Farber Cancer Institute (US)
  • Institut Curie (FR)
  • Université Libre de Bruxelles (BE)
  • University of Toronto (CA)
  • Aichi Cancer Center Hospital (JP)
  • University of Chicago (US)
  • The University of Sydney (AU)
  • University of Milan (IT)
  • Rutgers Cancer Institute (US)
  • Texas Oncology (US)
  • Peter MacCallum Cancer Centre (AU)
  • Levine Cancer Institute (US)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
  • Hospital Universitario Ramón y Cajal (ES)
Corresponding author
Adams, S.
ORCID
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2019-03
Volume
30
Issue
3
Pages
397-404
ISSN
0923-7534 (ISSN-L)
DOI
10.1093/annonc/mdy517
OpenAlex
W2902530914
Cited by
807
References
4
Citations by year
2026: 64 · 2025: 86 · 2024: 88 · 2023: 107 · 2022: 130 · 2021: 149 · 2020: 113 · 2019: 62 · 2018: 6 · 2017: 1
FWCI
25.01
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Oncology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • RECERCAT (Consorci de Serveis Universitaris de Catalunya) (publishedVersion, cc-by-nc-nd)
  • Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
  • RECERCAT (Consorci de Serveis Universitaris de Catalunya) (submittedVersion, cc-by-nc-nd)
  • INFM-OAR (INFN Catania) (submittedVersion, other-oa)
Funders
  • Merck Sharp & Dohme Corp.
  • Merck & Co., Inc.
  • Kenilworth
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Keywords
pembrolizumab, metastatic triple-negative breast cancer, PD-L1 expression, immune checkpoint inhibitor monotherapy, second-line therapy, objective response rate, progression-free survival, overall survival, treatment-related adverse events, anthracycline and taxane pretreated patients, disease control rate, duration of response
MeSH terms
Progression-Free Survival, Adult, Aged, Aged, 80 and over, Bridged-Ring Compounds, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Cohort Studies, Gene Expression Regulation, Neoplastic, Anthracyclines, Taxoids, B7-H1 Antigen, Antibodies, Monoclonal, Humanized, Triple Negative Breast Neoplasms

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