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Peer-reviewedCC BYnpj Breast Cancer

Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events

  • Hope S. Rugo1
  • David W. Cescon2
  • Peter Schmid3
  • Zbigniew Nowecki4
  • Seock-Ah Im5
  • Mastura Md Yusof6
  • Carlos Gallardo7
  • Hiroji Iwata8
  • Oleg Lipatov9
  • Felipe Cruz10
  • Carlos Henrique Barrios11
  • Roberto Hegg12
9 more authors
  • Sherene Loi13
  • Maria Gion14
  • Marco Torregroza Otero15
  • Péter Árkosy16
  • Rafal Tarnawski17
  • Lili Yao18
  • Jaime Mejia18
  • Wilbur Pan18
  • Javier Cortés19
19 affiliations
  1. 1City of Hope Comprehensive Cancer Center
  2. 2Princess Margaret Cancer Centre, University Health Network, University of Toronto
  3. 3Barts Cancer Institute, Centre for Experimental Cancer Medicine, Queen Mary University of London
  4. 4Breast Cancer and Reconstructive Surgery Department, Maria Sklodowska-Curie National Research Institute of Oncology
  5. 5Seoul National University Hospital, Seoul National University College of Medicine, Cancer Research Institute, Seoul National University
  6. 6Hospital PICASO
  7. 7Bradford Hill Research Center
  8. 8Nagoya City University
  9. 9Republican Clinical Oncology Dispensary of the Ministry of Public Health of Bashkortostan Republic
  10. 10Instituto Brasileiro de Controle do Câncer
  11. 11Latin American Cooperative Oncology Group (LACOG)
  12. 12Gynecological and Breast Oncology, Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda., Avenida Brigadeiro Luís Antônio
  13. 13Division of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, and The Sir Peter MacCallum Department of Medical Oncology, University of Melbourne
  14. 14Hospital Universitario Ramón y Cajal
  15. 15Oncomedica
  16. 16Department of Oncology, University of Debrecen
  17. 17Maria Sklodowska-Curie National Research Institute of Oncology
  18. 18Merck & Co., Inc.
  19. 19International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain; IOB Madrid, Hospital Beata Maria Ana, Madrid, Spain; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine
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Abstract

Pembrolizumab plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in the phase 3 randomized KEYNOTE-355 study in participants with previously untreated, advanced triple-negative breast cancer (TNBC) with PD-L1 combined positive score (CPS) ≥ 10. Among participants with clinical benefit from pembrolizumab plus chemotherapy, discontinuation of chemotherapy before pembrolizumab for any reason was associated with similar median PFS and OS to that in the overall population. Additionally, we further characterized immune-mediated adverse events (AEs) in KEYNOTE-355. Most immune-mediated AEs were manageable with treatment interruption and supportive care. In participants treated with pembrolizumab plus chemotherapy with immune-mediated AEs, there appeared to be numerical improvement in efficacy. This analysis provides additional information on the use of pembrolizumab plus chemotherapy as standard-of-care therapy in patients with previously untreated, advanced TNBC with PD-L1 CPS ≥ 10. This trial is registered at ClinicalTrials.gov (NCT02819518; registration date, June 28, 2016).

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Cite

BibTeXRIS
BibTeX
@article{rugo2026outcomes,
  title = {{Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events}},
  author = {Hope S. Rugo and David W. Cescon and Peter Schmid and Zbigniew Nowecki and Seock-Ah Im and Mastura Md Yusof and Carlos Gallardo and Hiroji Iwata and Oleg Lipatov and Felipe Cruz and Carlos Henrique Barrios and Roberto Hegg and Sherene Loi and Maria Gion and Marco Torregroza Otero and Péter Árkosy and Rafal Tarnawski and Lili Yao and Jaime Mejia and Wilbur Pan and Javier Cortés},
  journal = {npj Breast Cancer},
  year = {2026},
  month = jun,
  doi = {10.1038/s41523-026-00971-8},
  url = {https://doi.org/10.1038/s41523-026-00971-8},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events
AU  - Hope S. Rugo
AU  - David W. Cescon
AU  - Peter Schmid
AU  - Zbigniew Nowecki
AU  - Seock-Ah Im
AU  - Mastura Md Yusof
AU  - Carlos Gallardo
AU  - Hiroji Iwata
AU  - Oleg Lipatov
AU  - Felipe Cruz
AU  - Carlos Henrique Barrios
AU  - Roberto Hegg
AU  - Sherene Loi
AU  - Maria Gion
AU  - Marco Torregroza Otero
AU  - Péter Árkosy
AU  - Rafal Tarnawski
AU  - Lili Yao
AU  - Jaime Mejia
AU  - Wilbur Pan
AU  - Javier Cortés
PY  - 2026
DA  - 2026/06/01
JO  - npj Breast Cancer
DO  - 10.1038/s41523-026-00971-8
UR  - https://doi.org/10.1038/s41523-026-00971-8
AB  - Pembrolizumab plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in the phase 3 randomized KEYNOTE-355 study in participants with previously untreated, advanced triple-negative breast cancer (TNBC) with PD-L1 combined positive score (CPS) ≥ 10. Among participants with clinical benefit from pembrolizumab plus chemotherapy, discontinuation of chemotherapy before pembrolizumab for any reason was associated with similar median PFS and OS to that in the overall population. Additionally, we further characterized immune-mediated adverse events (AEs) in KEYNOTE-355. Most immune-mediated AEs were manageable with treatment interruption and supportive care. In participants treated with pembrolizumab plus chemotherapy with immune-mediated AEs, there appeared to be numerical improvement in efficacy. This analysis provides additional information on the use of pembrolizumab plus chemotherapy as standard-of-care therapy in patients with previously untreated, advanced TNBC with PD-L1 CPS ≥ 10. This trial is registered at ClinicalTrials.gov (NCT02819518; registration date, June 28, 2016).
SN  - 2374-4677
ER  -