Evidence map›Paper›PMID 42743832›Full record

ArticleBreast (Edinburgh, Scotland)2026

Pembrolizumab plus chemotherapy followed by pembrolizumab in participants in Asia with early triple-negative breast cancer: An updated subgroup analysis of the KEYNOTE-522 randomized clinical trial.

Yeon Hee Park, Rina Hui, Seock-Ah Im, Jin-Hee Ahn, Chiun-Sheng Huang, Min Hwan Kim, Shin-Cheh Chen, Hirofumi Mukai, Masato Takahashi, Hiroji Iwata and 15 more

Registry-linked trialAbstract read
In one paragraph

Article in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036488 (A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03036488 phase3completednot on this map

A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2025Enrolled1,174ConditionsTriple Negative Breast NeoplasmsArmsPembrolizumab, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Yeon Hee ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: yhparkhmo@skku.edu.
Rina HuiMedical Oncology Department, Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney, NSW, Australia. Electronic address: rina.hui@sydney.edu.au.
Seock-Ah ImDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Cancer Research Institute, Seoul National University, Seoul, Republic of Korea. Electronic address: moisa@snu.ac.kr.
Jin-Hee AhnDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: drjiny@amc.seoul.kr.
Chiun-Sheng HuangNational Taiwan University Hospital, College of Medicine, National Taiwan University and Taiwan Breast Cancer Consortium, Taipei, Taiwan. Electronic address: huangcs@ntu.edu.tw.
Min Hwan KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: GEMGOON3691@YUHS.AC.
Shin-Cheh ChenDepartment of General Surgery, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan. Electronic address: chensc@cgmh.org.tw.
Hirofumi MukaiDepartment of Medical Oncology, National Cancer Center Hospital East, Kashiwanoha, Kashiwa, Chiba, Japan. Electronic address: hrmukai@east.ncc.go.jp.
Masato TakahashiDepartment of Breast Surgery, Hokkaido University Hospital, Sapporo, Japan. Electronic address: masato.takahashi0725@gmail.com.
Hiroji IwataNagoya City University, Graduate School of Medical Science, Nagoya, Japan. Electronic address: h.iwata@med.nagoya-cu.ac.jp.
Javier CortésInternational Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain; IOB Madrid, Institute of Oncology, Hospital Beata Maria Ana, Madrid, Spain. Electronic address: javier.cortes@maj3.health.
Heather McArthurUniversity of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: heather.mcarthur@UTSouthwestern.edu.
Lajos PusztaiYale School of Medicine, Yale Cancer Center, New Haven, CT, USA. Electronic address: lajos.pusztai@yale.edu.
Sherko KümmelDepartment of Gynecology with Breast Center, Breast Unit, Kliniken Essen-Mitte, Essen, Germany; Charité - Universitätsmedizin Berlin, Department of Gynecology with Breast Center, Berlin, Germany. Electronic address: S.Kuemmel@kem-med.com.
Carsten DenkertInstitute of Pathology, Philipps-University Marburg and University Hospital Marburg, Marburg, Germany. Electronic address: Carsten.denkert@uni-marburg.de.
Joyce O'ShaughnessyBaylor University Medical Center, Texas Oncology, US Oncology Network, Dallas, TX, USA. Electronic address: Joyce.OShaughnessy@usoncology.com.
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center (CCC Munich LMU), LMU University Hospital, LMU Medizin, Ludwig-Maximilians-Universität München, Munich, Germany. Electronic address: nadia.harbeck@med.uni-muenchen.de.
Peter A FaschingUniversity Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.
Michael UntchBreast Cancer Center, Helios Klinikum Berlin-Buch, Berlin, Germany. Electronic address: michael.untch@helios-gesundheit.de.
Fatima CardosoBreast Unit, Champalimaud Clinical Center/Champalimaud Foundation and Advanced Breast Cancer (ABC) Global Alliance, Lisbon, Portugal. Electronic address: fcardoso@abcglobalalliance.org.
Liyi JiaMerck & Co., Inc., Rahway, NJ, USA. Electronic address: liyi.jia@merck.com.
Francisco BecaMerck & Co., Inc., Rahway, NJ, USA. Electronic address: francisco.beca@merck.com.
Jaime MejiaMerck & Co., Inc., Rahway, NJ, USA. Electronic address: jaime.mejia@merck.com.
Rebecca DentDepartment of Medical Oncology, National Cancer Center Singapore, Singapore; Duke-National University of Singapore Medical School, Singapore. Electronic address: rebecca.dent@duke-nus.edu.sq.
Peter SchmidCentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK. Electronic address: p.schmid@qmul.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn KEYNOTE-522 (NCT03036488), addition of perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved pathological complete response (pCR), event-free survival (EFS), and overall survival (OS) in early-stage triple-negative breast cancer (TNBC). pCR and EFS results in participants enrolled in Asia were consistent with those in the overall population. We report OS, updated EFS, and safety outcomes in participants enrolled in Asia.

methodsParticipants with newly diagnosed, high-risk, early-stage TNBC (T1c [N1‒N2] or T2‒T4 [N0‒N2] per AJCC 7th edition) were randomized 2:1 to 8 cycles of neoadjuvant pembrolizumab 200 mg Q3W or placebo plus chemotherapy. After definitive surgery, participants received adjuvant pembrolizumab 200 mg Q3W or placebo for ≤9 cycles. Primary endpoints were pCR (ypT0/Tis ypN0) and EFS. OS was a secondary endpoint.

resultsOf 1174 randomized participants, 216 were enrolled in Asia. At data cutoff (March 22, 2024), EFS events occurred in 18/136 participants (13.2%) in the pembrolizumab + chemotherapy group versus 22/80 (27.5%) in the placebo + chemotherapy group (HR, 0.43 [95% CI, 0.23‒0.81]); 60-month EFS rates (95% CIs) were 87.4% (80.6%‒92.0%) and 72.1% (60.7%‒80.6%), respectively. In the respective groups, 12/136 (8.8%) and 16/80 participants (20.0%) died (HR, 0.41 [95% CI, 0.19‒0.86]); 60-month OS rates (95% CIs) were 91.9% (85.8%‒95.4%) and 81.1% (70.5%‒88.1%). Treatment-related AEs led to treatment discontinuation in 19/136 participants (14.0%) with pembrolizumab + chemotherapy and 7/79 (8.9%) with placebo + chemotherapy.

conclusionsOS and updated EFS outcomes in KEYNOTE-522 participants enrolled in Asia were consistent with those in the overall population and support use of perioperative pembrolizumab + neoadjuvant chemotherapy as a standard-of-care treatment in this setting.

Indexed as

AdjuvantChemotherapyNeoadjuvantPembrolizumabTNBC

Identifiers

PMID42743832
PMCPMC13597290

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.