Evidence map›Paper›PMID 39266535›Full record

ArticleNPJ breast cancer2024

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

Seock-Ah Im, Javier Cortes, David W Cescon, Mastura Md Yusof, Hiroji Iwata, Norikazu Masuda, Toshimi Takano, Chiun-Sheng Huang, Chi-Feng Chung, Koichiro Tsugawa and 10 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ breast cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02819518 (A Randomized, Double-Blind, Phase III Study of Pembrolizumab), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–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.

NCT02819518 phase3completednot on this map

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2016 to 2023Enrolled882ConditionsTriple Negative Breast Cancer (TNBC)ArmsPembrolizumab, Nab-paclitaxel, Paclitaxel, Gemcitabine, Carboplatin
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  16. Immunotherapy for triple-negative breast cancer: current trends and future prospects.Journal of the Egyptian National Cancer Institute · 2025
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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

20 authors.

Seock-Ah ImSeoul National University Hospital, Seoul National University College of Medicine, Cancer Research Institute, Seoul National University, Seoul, Republic of Korea. moisa@snu.ac.kr.ORCID http://orcid.org/0000-0002-5396-6533
Javier CortesInternational Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Madrid and Barcelona, Spain.ORCID http://orcid.org/0000-0001-7623-1583
David W CesconDepartment of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.ORCID http://orcid.org/0000-0002-1080-0998
Mastura Md YusofCancer Center at Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Hiroji IwataAichi Cancer Center Hospital, Nagoya, Aichi, Japan.
Norikazu MasudaNagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.ORCID http://orcid.org/0000-0002-7302-0278
Toshimi TakanoThe Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID http://orcid.org/0000-0002-8417-5291
Chiun-Sheng HuangNational Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-6557-211X
Chi-Feng ChungKoo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan.
Koichiro TsugawaSt. Marianna University Hospital, Kawasaki, Japan.
Yeon Hee ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-4156-9212
Koji MatsumotoHyogo Cancer Center, Akashi, Hyogo, Japan.ORCID http://orcid.org/0000-0003-1907-0247
Kenichi InoueSaitama Cancer Center, Saitama, Japan.
Ava KwongDivision of Breast Surgery, The University of Hong Kong, Queen Mary and Tung Wah Hospital, Hong Kong, China.ORCID http://orcid.org/0000-0002-6968-9489
Sherene LoiDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.ORCID http://orcid.org/0000-0001-6137-9171
Wei FuMerck & Co., Inc., Rahway, NJ, USA.
Wilbur PanMerck & Co., Inc., Rahway, NJ, USA.ORCID http://orcid.org/0000-0002-9714-6078
Vassiliki KarantzaMerck & Co., Inc., Rahway, NJ, USA.
Hope S RugoUniversity of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-6710-4814
Peter SchmidCentre for Experimental Cancer Medicine, Barts Cancer Institute, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Identifiers

PMID39266535
PMCPMC11393332

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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.