The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.
FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer
Open accessAbstract
On July 26, 2021, the FDA granted approval to pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as a single agent for adjuvant treatment following surgery for patients with high-risk, early-stage triple-negative breast cancer. Approval was based on results from KEYNOTE-522, an ongoing randomized (2:1) trial evaluating pembrolizumab or placebo in combination with chemotherapy for neoadjuvant treatment and then as a single agent for adjuvant treatment. The co-primary endpoints were pathological complete response (pCR) rate and event-free survival (EFS). The trial demonstrated an improvement in pCR and EFS in the pembrolizumab arm compared with the control arm. The number of patients who experienced an EFS event was 123 (16%) and 93 (24%), respectively [HR: 0.63, 95% confidence interval (CI), 0.48–0.82, P = 0.00031]. Patients on the pembrolizumab arm experienced EFS benefit regardless of tumor PD-L1 status. The absolute pCR rate improvement with the addition of pembrolizumab was 7.5% (95% CI, 1.6–13.4). Among patients receiving pembrolizumab, 44% experienced an immune-related adverse reaction. This article summarizes FDA's review of pembrolizumab and the data supporting the favorable benefit–risk assessment.
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Immune checkpoint inhibitors as monotherapy have limited efficacy in the treatment of relapsed/refractory multiple myeloma.
“However, the efficacy of these antibodies particularly as monotherapy was limited in the treatment of RRMM [173–176].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [174]
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Pembrolizumab for Early Triple-Negative Breast Cancer
Schmid, P., Cortes, J., Pusztai, L., McArthur, H., Kümmel, S., Bergh, J., Denkert, C., Park, Y. H., Hui, R., Harbeck, N., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1910549 · Cited by 3,270
Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer
Schmid, P., Cortes, J., Dent, R., Pusztai, L., McArthur, H., Kümmel, S., Bergh, J., Denkert, C., Park, Y. H., Hui, R., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2112651 · Cited by 1,274
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Research works printed but not linked: 9
- Sikov, 2019, CALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) ± carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC), J Clin Oncol, 10.1200/JCO.2019.37.15_suppl.591 · DOI
- Masuda, 2017, Adjuvant capecitabine for breast cancer after preoperative chemotherapy, N Engl J Med, 376, 2147, 10.1056/NEJMoa1612645 · DOI
- Amiri-Kordestani, 2014, First FDA approval of neoadjuvant therapy for breast cancer: pertuzumab for the treatment of patients with HER2-positive breast cancer, Clin Cancer Res, 20, 5359, 10.1158/1078-0432.CCR-14-1268 · DOI
- Cortazar, 2014, Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis, Lancet, 384, 164, 10.1016/S0140-6736(13)62422-8 · DOI
- Huang, 2020, Evaluation of pathologic complete response as a surrogate for long-term survival outcomes in triple-negative breast cancer, J Natl Compr Canc Netw, 18, 1096, 10.6004/jnccn.2020.7550 · DOI
- Royce, 2022, FDA approval summary: abemaciclib with endocrine therapy for high-risk early breast cancer, J Clin Oncol, 40, 1155, 10.1200/JCO.21.02742 · DOI
- Yau, 2022, Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients, Lancet Oncol, 23, 149, 10.1016/S1470-2045(21)00589-1 · DOI
- von Minckwitz, 2018, Trastuzumab emtansine for residual invasive HER2-positive breast cancer, N Engl J Med, 380, 617, 10.1056/NEJMoa1814017 · DOI
- Prowell, 2019, Residual disease after neoadjuvant therapy—developing drugs for high-risk early breast cancer, N Engl J Med, 380, 612, 10.1056/NEJMp1900079 · DOI
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Multiple myeloma: signaling pathways and targeted therapy
Lu, Q., Yang, D., Li, H., Niu, T., & Tong, A. (2024) · Molecular biomedicine · doi:10.1186/s43556-024-00188-w · Cited by 90
The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer
Abraham, J. E., Pinilla, K., Dayimu, A., Grybowicz, L., Demiris, N., Harvey, C., Drewett, L. M., Lucey, R., Fulton, A., Roberts, A. N., et al. (2024) · Nature · doi:10.1038/s41586-024-07384-2 · Cited by 53
Metadata
- Authors
- Shah, M., Osgood, C. L., Amatya, A. K., Fiero, M. H., Pierce, W. F., Nair, A., Herz, J., Robertson, K. J., Mixter, B. D., Tang, S., Pazdur, R., Beaver, J. A., & Amiri-Kordestani, L.
- Affiliations
- United States Food and Drug Administration (US)
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
- Corresponding author
- Shah, Mirat
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2022-08-04
- Volume
- 28
- Issue
- 24
- Pages
- 5249-5253
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- OpenAlex
- W4289780812
- Cited by
- 105
- References
- 2
- Citations by year
- 2026: 22 · 2025: 33 · 2024: 32 · 2023: 16 · 2022: 2
- FWCI
- 8.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Food and Drug Administration
- 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 › Oncology › Advanced Breast Cancer Therapies
- Keywords
- pembrolizumab, triple-negative breast cancer, neoadjuvant therapy, adjuvant therapy, early breast cancer, PD-L1, immune checkpoint inhibitors, combination chemotherapy, pathological complete response, event-free survival, immune-related adverse events, FDA drug approval, KEYNOTE-522
- MeSH terms
- Progression-Free Survival, Antineoplastic Combined Chemotherapy Protocols, Humans, Neoadjuvant Therapy, Antibodies, Monoclonal, Humanized, Triple Negative Breast Neoplasms
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