Evidence map›Paper›PMID 37290035›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial.

Emmanuel S Antonarakis, Se Hoon Park, Jeffrey C Goh, Sang Joon Shin, Jae Lyun Lee, Niven Mehra, Ray McDermott, Núria Sala-Gonzalez, Peter C Fong, Richard Greil and 21 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03834519 (A Phase 3, Randomized Open-label Study of Pembrolizumab), which is not on this map. Cited by 88 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 7 pooled it
32.3field-weighted citation impact, top 1% of its field
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.

NCT03834519 phase3completednot on this map

A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2019 to 2024Enrolled793ConditionsProstatic NeoplasmsArmsPembrolizumab, Olaparib, Abiraterone acetate, Prednisone, Enzalutamide
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 7 syntheses or guidelines pooled it, 125 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Guideline
  6. Pooled it
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  8. Trial
  9. Trial
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  11. Evaluating Immune Checkpoint Blockade in Metastatic Castration-Resistant Prostate Cancers with Deleterious CDK12 Alterations in the Phase 2 IMPACT Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  12. Article
  13. Article
  14. Review
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  18. Article
  19. B7-H3 Gene Expression Shapes Prognosis and Therapeutic Opportunities across Patient Groups with Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  20. Review

28 more citing papers are in PubMed but not listed here.

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

31 authors at 20 institutions in 18 countries.

Emmanuel S AntonarakisJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.ORCID 0000-0003-3531-3851
Se Hoon ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.ORCID 0000-0001-5084-9326
Jeffrey C GohRoyal Brisbane & Women's Hospital, Herston, Australia.ORCID 0000-0003-3103-146X
Sang Joon ShinSeverance Hospital Yonsei University Health System, Seoul, South Korea.
Jae Lyun LeeAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.ORCID 0000-0002-9420-7162
Niven MehraRadboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-4794-1831
Ray McDermottSt Vincent's University Hospital, Cancer Trials Ireland, Dublin, Ireland.ORCID 0000-0002-8952-4315
Núria Sala-GonzalezInstitut Català d Oncologia Girona, Hospital Josep Trueta, Girona, Spain.
Peter C FongAuckland City Hospital, University of Auckland, Auckland, New Zealand.ORCID 0000-0003-2689-8958
Richard GreilSalzburg Cancer Research Institute-CCCIT Gmbh, Paracelsus Medical University Salzburg, Cancer Cluster Salzburg, Salzburg, Austria.
Margitta RetzRechts der Isar Medical Center, Technical University Munich, Munich, Germany.
Juan Pablo SadeInstituto Medico Alexander Fleming, Buenos Aires, Argentina.
Patricio YanezJames Lind Cancer Research Center, Universidad de La Frontera, Temuco, Chile.
Yi-Hsiu HuangTaipei Veterans General Hospital, National Yang Ming Chiao Tung University, Taipei, Taiwan.ORCID 0000-0002-2561-635X
Stephen D BegbiePort Macquarie Base Hospital, Port Macquarie, Australia.ORCID 0000-0001-9277-6479
Rustem Airatovich GafanovRussian Scientific Center of Roentgenoradiology, Moscow, Russian Federation.ORCID 0000-0002-7592-0392
Maria De SantisCharité Universitaetsmedizin Berlin-Campus Mitte, Berlin, Germany.
Eli RosenbaumRabin Medical Center, Petach-Tikwa, Israel.
Michael P KolinskyCross Cancer Institute, University of Alberta, Edmonton, AB, Canada.
Felipe ReyClinica CIDO, Temuco, Chile.ORCID 0009-0007-9924-6367
Kun-Yuan ChiuTaichung Veterans General Hospital, Taichung, Taiwan.
Guilhem RoubaudInstitut Bergonié, Bordeaux, France.
Gero KramerDepartment of Urology, Medical University of Vienna, Vienna, Austria.
Makoto SumitomoFujita Health University Hospital, Toyoake, Japan.ORCID 0000-0003-2589-922X
Francesco MassariMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.ORCID 0000-0001-6476-6871
Hiroyoshi SuzukiToho University Sakura Medical Center, Chiba, Japan.
Ping QiuMerck & Co, Inc, Rahway, NJ.ORCID 0000-0003-4090-5704
Jinchun ZhangMerck & Co, Inc, Rahway, NJ.ORCID 0000-0002-0072-7571
Jeri KimMerck & Co, Inc, Rahway, NJ.
Christian H PoehleinMerck & Co, Inc, Rahway, NJ.
Evan Y YuFred Hutchinson Cancer Center, University of Washington, Seattle, WA.ORCID 0000-0002-1510-8044
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMedical University of Vienna · ATAzienda USL di Bologna · ITCancer Trials Ireland · IEFederal State Budgetary Institution Russian Scientific Center of Roentgenoradiology · RUFujita Health University Hospital · JPInstitut Bergonié · FRInstitut Català d'Oncologia · ESInstituto Alexander Fleming · ARNational Yang Ming Chiao Tung University · TWParacelsus Medical University · ATPort Macquarie Base Hospital · AURabin Medical Center · ILRadboud University Nijmegen · NLRoyal Brisbane and Women's Hospital · AUSamsung Medical Center · KRSeverance Hospital · KRTaichung Veterans General Hospital · TWToho University · JPTUM Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThere is an unmet need for therapeutic options that prolong survival for patients with heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC). The phase III, open-label KEYLYNK-010 study evaluated pembrolizumab plus olaparib versus a next-generation hormonal agent (NHA) for biomarker-unselected, previously treated mCRPC.

methodsEligible participants had mCRPC that progressed on or after abiraterone or enzalutamide (but not both) and docetaxel. Participants were randomly assigned (2:1) to pembrolizumab plus olaparib or NHA (abiraterone or enzalutamide). The dual primary end points were radiographic progression-free survival (rPFS) by blinded independent central review per Prostate Cancer Working Group-modified RECIST 1.1 and overall survival (OS). Time to first subsequent therapy (TFST) was a key secondary end point. Safety and objective response rate (ORR) were secondary end points.

resultsBetween May 30, 2019, and July 16, 2021, 529 participants were randomly assigned to pembrolizumab plus olaparib and 264 to NHA. At final rPFS analysis, median rPFS was 4.4 months (95% CI, 4.2 to 6.0) with pembrolizumab plus olaparib and 4.2 months (95% CI, 4.0 to 6.1) with NHA (hazard ratio [HR], 1.02 [95% CI, 0.82 to 1.25];

conclusionPembrolizumab plus olaparib did not significantly improve rPFS or OS versus NHA in participants with biomarker-unselected, heavily pretreated mCRPC. The study was stopped for futility. No new safety signals occurred.

Indexed as

Prostatic Neoplasms, Castration-ResistantAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBiomarkersDisease-Free SurvivalHumansMaleNitrilesPhenylthiohydantoinPhthalazinesPiperazinesPrednisoneTreatment OutcomeAntibodies, Monoclonal, HumanizedBenzamidesBiomarkersenzalutamideNitrilesolaparibpembrolizumabPhenylthiohydantoinPhthalazinesPiperazinesPrednisone

Identifiers

PMID37290035
PMCPMC10419579
OpenAlexW4379791997

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.