Evidence map›Paper›PMID 40575946›Full record

Trial reportCancer research and treatment2026

Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma in the East Asian Subgroup of the Phase 3 KEYNOTE-564 Study.

Se Hoon Park, Yen-Hwa Chang, Jae Lyun Lee, Toni K Choueiri, Go Kimura, Jinsoo Chung, Naoya Masumori, Kazuo Nishimura, Minoru Kato, Haruaki Kato and 9 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

19 authors.

Se Hoon ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Yen-Hwa ChangDepartment of Urology, Taipei Veterans General Hospital, Taipei, Taiwan.
Jae Lyun LeeDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Toni K ChoueiriDepartment of Medical Oncology, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Boston, MA, USA.
Go KimuraDepartment of Urology, Nippon Medical School Hospital, Tokyo, Japan.
Jinsoo ChungDepartment of Urology, National Cancer Center, Goyang, Korea.
Naoya MasumoriDepartment of Urology, Sapporo Medical University Hospital, Sapporo, Japan.
Kazuo NishimuraDepartment of Urology, Osaka International Cancer Institute, Osaka, Japan.
Minoru KatoDepartment of Urology, Osaka Metropolitan University Hospital, Osaka, Japan.
Haruaki KatoDepartment of Urology, Nagano Municipal Hospital, Nagano, Japan.
Kazuyuki NumakuraDepartment of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Chao-Hsiang ChangDepartment of Urology, China Medical University Hospital, Taichung, Taiwan.
Satoshi AnaiNara Prefecture Seiwa Medical Center, Nara, Japan.
Hiroyuki TsunemoriTakinomiya General Hospital, Ayagawa, Japan.
Chung-Hsin ChenDepartment of Urology, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.
Jianxin LinMerck & Co., Inc., Rahway, NJ, USA.
Aymen ElfikyMerck & Co., Inc., Rahway, NJ, USA.
Joseph E BurgentsMerck & Co., Inc., Rahway, NJ, USA.
Hiroshi KitamuraDepartment of Urology, University of Toyama, Toyama, Japan.

Funding

Merck & Co., Inc.Merck Sharp & Dohme LLC
6 · The paper itself

Abstract

purposeAdjuvant pembrolizumab improved disease-free survival (DFS) and overall survival (OS) versus placebo in participants with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy in the global phase 3 KEYNOTE-564 study. This post hoc subgroup analysis evaluated the efficacy and safety of adjuvant pembrolizumab in East Asian (Japan, South Korea, and Taiwan) participants enrolled in KEYNOTE-564. MATERIALS AND

methodsEligible participants were randomly assigned 1:1 to receive adjuvant pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 17 cycles. The primary endpoint was DFS by investigator assessment. OS was a key secondary endpoint. Safety was a secondary endpoint.

resultsThe East Asian subgroup included 126 participants (pembrolizumab, n=58; placebo, n=68). Median follow-up was 62.1 months (range, 49.6 to 73.0 months). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41 to 1.20). Median DFS was not reached with pembrolizumab versus 58.8 months with placebo; estimated 48-month rate was 61.3% versus 51.2%. Hazard ratio for OS was 0.47 (95% confidence interval, 0.15 to 1.49). Median OS was not reached with pembrolizumab and placebo; estimated 48-month rate was 94.8% versus 91.2%. Treatment-related adverse events occurred in 70.7% of participants (29.3% grade 3 or 4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3 or 4) receiving placebo. No pembrolizumab-related deaths occurred.

conclusionIn the KEYNOTE-564 East Asian subgroup, adjuvant pembrolizumab provided DFS and OS benefits versus placebo and had a safety profile consistent with the global results. These results further support pembrolizumab as adjuvant treatment for East Asian patients with RCC at increased risk of recurrence after nephrectomy.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Renal CellKidney NeoplasmsAdultAgedChemotherapy, AdjuvantEast Asian PeopleFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalpembrolizumabAsiaImmunoadjuvantPD-1 inhibitorPembrolizumabRenal cell carcinoma

Identifiers

PMID40575946
PMCPMC13093030

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.