Abstract | Importance: Objective: To evaluate efficacy and safety outcomes for patients enrolled in East/Southeast Asia (Asia) in KEYNOTE-522. Design, Setting, and Participants: KEYNOTE-522, a multicenter, double-blind, randomized clinical trial, enrolled 1174 patients between March 7, 2017, and September 13, 2018. For interim EFS and overall survival (OS) analyses (data cutoff, March 23, 2021), median follow-up was 39.8 months (range, 30.4-46.9 months) for pembrolizumab plus chemotherapy and 40.8 months (range, 30.1-46.9 months) for placebo plus chemotherapy. Data cutoff for pCR analysis was September 24, 2018. This secondary analysis included adults enrolled in Asia with newly diagnosed, previously untreated, nonmetastatic triple-negative breast cancer ( tumor stage T1c and nodal stage N1-2 or tumor stage T2-4 and nodal stage N0-2) and Eastern Cooperative Oncology Group performance status of 0 to 1, regardless of programmed cell death ligand 1 (PD-L1) status. Intervention: Main Outcomes and Measures: Results: A total of 216 of 1174 randomized patients (all female; median [range] age, 46.0 [24.0-71.0] years) were from Korea, Japan, Taiwan, and Singapore (136 in the pembrolizumab plus chemotherapy group and 80 in the placebo plus chemotherapy group). Of these patients, 104 (76.5%) in the pembrolizumab plus chemotherapy group and 60 (75.0%) in the placebo plus chemotherapy group had a tumor PD-L1 combined positive score of 1 or greater. Pathologic complete response was 58.7% (95% CI, 46.7%-69.9%) with pembrolizumab plus chemotherapy and 40.0% (95% CI, 26.4%-54.8%) with placebo plus chemotherapy; benefit was observed regardless of PD-L1 status. Thirteen patients (9.6%) in the pembrolizumab plus chemotherapy group and 20 patients (25.0%) in the placebo plus chemotherapy group had EFS events (hazard ratio, 0.35; 95% CI, 0.17-0.71). The 36-month EFS rate was 91.2% (95% CI, 85.0%-94.9%) with pembrolizumab plus chemotherapy and 77.2% (95% CI, 66.3%-85.0%) with placebo plus chemotherapy. Grade 3 to 4 treatment-related adverse events occurred in 109 patients (80.1%) receiving pembrolizumab plus chemotherapy and 64 patients (81.0%) receiving placebo plus chemotherapy. Conclusions and Relevance: Trial Registration: ClinicalTrials.gov Identifier: NCT03036488.
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Authors | Masato Takahashi, Javier Cortés, Rebecca Dent, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Carsten Denkert, Yeon Hee Park, Seock-Ah Im, Jin-Hee Ahn, Hirofumi Mukai, Chiun-Sheng Huang, Shin-Cheh Chen, Min Hwan Kim, Liyi Jia, Xin Tong Li, Konstantinos Tryfonidis, Vassiliki Karantza, Hiroji Iwata, Peter Schmid |
Journal | JAMA network open
(JAMA Netw Open)
Vol. 6
Issue 11
Pg. e2342107
(Nov 01 2023)
ISSN: 2574-3805 [Electronic] United States |
PMID | 37966841
(Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article)
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Chemical References |
- pembrolizumab
- B7-H1 Antigen
- Antibodies, Monoclonal, Humanized
- Adjuvants, Immunologic
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Topics |
- Adult
- Humans
- Female
- Middle Aged
- Triple Negative Breast Neoplasms
(drug therapy)
- B7-H1 Antigen
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Asia
- Adjuvants, Immunologic
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