Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study
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Purpose: Immune checkpoint inhibition has been demonstrated to be an effective anticancer strategy. Several lines of evidence support the study of immunotherapy in triple-negative breast cancer (TNBC). We assessed the safety and antitumor activity of the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab in patients with advanced TNBC. Methods: KEYNOTE-012 ( ClinicalTrials.gov identifier: NCT01848834) was a multicenter, nonrandomized phase Ib trial of single-agent pembrolizumab given intravenously at 10 mg/kg every 2 weeks to patients with advanced PD-L1–positive (expression in stroma or ≥ 1% of tumor cells by immunohistochemistry) TNBC, gastric cancer, urothelial cancer, and head and neck cancer. This report focuses on the TNBC cohort. Results: Among 111 patients with TNBC whose tumor samples were screened for PD-L1 expression, 58.6% had PD-L1–positive tumors. Thirty-two women (median age, 50.5 years; range, 29 to 72 years) were enrolled and assessed for safety and antitumor activity. The median number of doses administered was five (range, 1 to 36 doses). Common toxicities were mild and similar to those observed in other tumor cohorts (eg, arthralgia, fatigue, myalgia, and nausea), and included five (15.6%) patients with grade ≥ 3 toxicity and one treatment-related death. Among the 27 patients who were evaluable for antitumor activity, the overall response rate was 18.5%, the median time to response was 17.9 weeks (range, 7.3 to 32.4 weeks), and the median duration of response was not yet reached (range, 15.0 to ≥ 47.3 weeks). Conclusion: This phase Ib study describes preliminary evidence of clinical activity and a potentially acceptable safety profile of pembrolizumab given every 2 weeks to patients with heavily pretreated, advanced TNBC. A single-agent phase II study examining a 200-mg dose given once every 3 weeks ( ClinicalTrials.gov identifier: NCT02447003) is ongoing.
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Immune checkpoint blockade directed against PD-1 or PD-L1 has shown promising results in TNBC, but the overall response rate is less than 20%.
“Immune checkpoint blockade (ICB) directed against programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) has shown promising results in TNBC4–6, but the overall response rate of ICB is less than 20%7.”
Antibodies blocking PD-1 or PD-L1 have been approved to treat various solid and hematologic malignancies.
“At present, antibodies blocking PD-1 or its ligand PD-L1 have been approved to treat various solid and hematologic malignancies (Table 1) [7–12].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [10]
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Zhang, J. Q., & Plitas, G. (2021) · Journal of Surgical Oncology · doi:10.1002/jso.26287 · Cited by 6 · see citing works
Yuan, Z., Liu, Z., Zhou, M., Wen, H., & Li, B. (2026) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2025.105111 · Cited by 6 · see citing works
- Authors
- Nanda, R., Chow, L. Q. M., Dees, E. C., Berger, R., Gupta, S., Geva, R., Pusztai, L., Pathiraja, K., Aktan, G., Cheng, J. D., Karantza, V., & Buisseret, L.
- Affiliations
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- University of Washington (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2016-07-20
- Volume
- 34
- Issue
- 21
- Pages
- 2460-2467
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC6816000
- OpenAlex
- W2345415641
- Cited by
- 1,477
- References
- 42
- Citations by year
- 2026: 57 · 2025: 97 · 2024: 110 · 2023: 147 · 2022: 147 · 2021: 191 · 2020: 186 · 2019: 165 · 2018: 162 · 2017: 170 · 2016: 43 · 2015: 1
- FWCI
- 96.94
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Funders
- National Cancer Institute (P30CA016086)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
- Keywords
- pembrolizumab, triple-negative breast cancer, PD-1 inhibitors, immune checkpoint blockade, PD-L1 expression, anticancer activity, drug safety, immunotherapy, advanced cancer, heavily pretreated patients
- MeSH terms
- Adult, Aged, Antineoplastic Agents, Female, Humans, L-Lactate Dehydrogenase, Middle Aged, Antibodies, Monoclonal, Humanized, Triple Negative Breast Neoplasms
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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