Pembrolizumab monotherapy for previously untreated,PD-L1-positive,metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study |
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| Institution: | 1. Department of Medicine, Perlmutter Cancer Center, New York University School of Medicine, New York, USA;2. Division of Research and Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia;3. Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, USA;4. Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada;5. Dipartimento di Senologia, Istituto Nazionale Tumori – “Fondazione Pascale,” Naples, Italy;6. Section of Hematology/Oncology, Department of Medicine, The University of Chicago, Chicago;7. Medical Oncology, Dana-Farber Cancer Institute, Boston, USA;8. Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa;9. Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;10. Breast Disease Research Group, The Christie NHS Foundation Trust, Manchester, UK;11. Department of Oncology, Mayo Clinic, Rochester, USA;12. Aichi Cancer Center Hospital, Nagoya, Japan;13. Division of Oncology, Sourasky Medical Center (Ichilov), Tel Aviv, Israel;14. Department of Gynecology and Obstetric, University Carl Gustav Carus, TU Dresden, Dresden, Germany;15. Department of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco;16. Levine Cancer Institute, Atrium Health, Charlotte;17. Merck & Co., Inc., Kenilworth, USA;18. Centre for Experimental Cancer Medicin, Barts Cancer Institute, Queen Mary University London, London, UK |
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| Abstract: | BackgroundStandard first-line treatment of metastatic triple-negative breast cancer (mTNBC) is chemotherapy. However, outcomes are poor, and new treatment options are needed. In cohort B of the phase II KEYNOTE-086 study, we evaluated pembrolizumab as first-line therapy for patients with PD-L1-positive mTNBC.Patients and methodsEligible patients had centrally confirmed mTNBC, no prior systemic anticancer therapy for metastatic disease, measurable disease at baseline per RECIST v1.1 by central review, no radiographic evidence of central nervous system metastases, and a tumor PD-L1 combined positive score ≥1. Patients received pembrolizumab 200 mg intravenously every 3 weeks for up to 2 years. The primary end point was safety. Secondary end points included objective response rate, disease control rate (percentage of patients with complete or partial response or stable disease for ≥24 weeks), duration of response, progression-free survival and overall survival.ResultsAll 84 patients enrolled were women, and 73 (86.9%) received prior (neo)adjuvant therapy. Fifty-three (63.1%) patients had treatment-related adverse events (AEs), including 8 patients (9.5%) with grade 3 severity; no patients experienced grade 4 AEs or died because of treatment-related AEs. Four patients had a complete response and 14 had a partial response, for an objective response rate of 21.4% (95% CI 13.9–31.4). Of the 13 patients with stable disease, 2 had stable disease lasting ≥24 weeks, for a disease control rate of 23.8% (95% CI 15.9–34.0). At data cut-off, 8 of 18 (44.4%) responses were ongoing, and median duration of response was 10.4 months (range 4.2 to 19.2+). Median progression-free survival was 2.1 months (95% CI 2.0–2.2), and median overall survival was 18.0 months (95% CI 12.9–23.0).ConclusionsPembrolizumab monotherapy had a manageable safety profile and showed durable antitumor activity as first-line therapy for patients with PD-L1-positive mTNBC.Clinical trial registrationClinicalTrials.gov, NCT02447003. |
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