Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC

In the phase 3 KEYNOTE-355 study (NCT02819518), pembrolizumab plus chemotherapy demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) versus placebo plus chemotherapy among patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) and programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 10 tumors. We analyzed outcomes for the subgroup of patients enrolled in Asia in KEYNOTE-355. Patients received pembrolizumab 200 mg or placebo (2:1 randomization) every 3 weeks for 35 cycles plus investigator's choice chemotherapy. Primary endpoints were PFS per Response Evaluation Criteria in Solid Tumors version 1.1 and OS. Among patients enrolled in Hong Kong, Japan, Korea, Malaysia and Taiwan (pembrolizumab plus chemotherapy, n = 113; placebo plus chemotherapy, n = 47), 117 (73.1%) had PD-L1 CPS ≥ 1 and 56 (35.0%) had PD-L1 CPS ≥ 10. Median time from randomization to data cutoff (June 15, 2021) was 43.8 (range, 36.8‒53.2) months (intent-to-treat [ITT] population). Hazard ratios (HRs [95% CI]) for PFS in the CPS ≥ 10, CPS ≥ 1, and ITT populations were 0.48 (0.24‒0.98), 0.58 (0.37‒0.91), and 0.66 (0.44‒0.99), respectively. Corresponding HRs (95% CI) for OS were 0.54 (0.28‒1.04), 0.62 (0.40‒0.97), and 0.57 (0.39‒0.84). Grade 3/4 treatment-related adverse events (AEs) occurred in 77.9% versus 78.7% of patients with pembrolizumab plus chemotherapy versus placebo plus chemotherapy. No grade 5 AEs occurred. Clinically meaningful improvement in PFS and OS with manageable toxicity were observed with pembrolizumab plus chemotherapy versus placebo plus chemotherapy in patients enrolled in Asia with previously untreated, inoperable or metastatic TNBC.Trial registration: ClinicalTrials.gov, NCT02819518.

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Publication Details

Journal
npj Breast Cancer
Published
2024-09-12
DOI
https://doi.org/10.1038/s41523-024-00679-7
Citations
18
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
Field-Weighted Citation Impact
5.09

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article

Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC

Sherene Loi, Ava Kwong, Chiun‐Sheng Huang, Wei Fu et al.
18 citations
npj Breast Cancer
Cancer Immunotherapy and Biomarkers
5.09
article

Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC

Sherene Loi, Ava Kwong, Chiun‐Sheng Huang, Wei Fu, Mastura Md Yusof, Toshimi Takano, Wilbur Pan, Javier Cortés, Hiroji Iwata, Chi-Feng Chung, Peter Schmid, David W. Cescon, Koichiro Tsugawa, Norikazu Masuda, Seock‐Ah Im, Koji Matsumoto, Vassiliki Karantza, Hope S. Rugo, Kenichi Inoue, Yeon Hee Park
article en
18 citations

Abstract

In the phase 3 KEYNOTE-355 study (NCT02819518), pembrolizumab plus chemotherapy demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) versus placebo plus chemotherapy among patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) and programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 10 tumors. We analyzed outcomes for the subgroup of patients enrolled in Asia in KEYNOTE-355. Patients received pembrolizumab 200 mg or placebo (2:1 randomization) every 3 weeks for 35 cycles plus investigator's choice chemotherapy. Primary endpoints were PFS per Response Evaluation Criteria in Solid Tumors version 1.1 and OS. Among patients enrolled in Hong Kong, Japan, Korea, Malaysia and Taiwan (pembrolizumab plus chemotherapy, n = 113; placebo plus chemotherapy, n = 47), 117 (73.1%) had PD-L1 CPS ≥ 1 and 56 (35.0%) had PD-L1 CPS ≥ 10. Median time from randomization to data cutoff (June 15, 2021) was 43.8 (range, 36.8‒53.2) months (intent-to-treat [ITT] population). Hazard ratios (HRs [95% CI]) for PFS in the CPS ≥ 10, CPS ≥ 1, and ITT populations were 0.48 (0.24‒0.98), 0.58 (0.37‒0.91), and 0.66 (0.44‒0.99), respectively. Corresponding HRs (95% CI) for OS were 0.54 (0.28‒1.04), 0.62 (0.40‒0.97), and 0.57 (0.39‒0.84). Grade 3/4 treatment-related adverse events (AEs) occurred in 77.9% versus 78.7% of patients with pembrolizumab plus chemotherapy versus placebo plus chemotherapy. No grade 5 AEs occurred. Clinically meaningful improvement in PFS and OS with manageable toxicity were observed with pembrolizumab plus chemotherapy versus placebo plus chemotherapy in patients enrolled in Asia with previously untreated, inoperable or metastatic TNBC.Trial registration: ClinicalTrials.gov, NCT02819518.

npj Breast CancerVol. 10(1)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US), University Health Network (CA), St. Marianna University School of Medicine (JP), The University of Melbourne (AU), University of California, San Francisco (US), University of Toronto (CA), Hospital Kuala Lumpur (MY), Peter MacCallum Cancer Centre (AU), Tung Wah Hospital (CN), Samsung Medical Center (KR), Princess Margaret Cancer Centre (CA), Seoul National University Hospital (KR), Saitama Cancer Center (JP), National Taiwan University Hospital (TW), Aichi Cancer Center (JP), Koo Foundation Sun Yat-Sen Cancer Center (TW), The Cancer Institute Hospital (JP), University of Hong Kong - Shenzhen Hospital (CN), Hyogo Prefectural Cancer Center (JP), Toranomon Hospital (JP), UCSF Helen Diller Family Comprehensive Cancer Center (US), Nagoya University (JP), Sungkyunkwan University (KR), University of Hong Kong (HK), Universidad Europea de Madrid (ES)
Breast Cancer Research Foundation, National Breast Cancer Foundation
Openalex Percentile: Top 3%
Cancer Immunotherapy and Biomarkers
5.09
DOIOpen Access PDFOpenAlex
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