Evidence map›Paper›PMID 31609651›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma.

Philippe Armand, Scott Rodig, Vladimir Melnichenko, Catherine Thieblemont, Kamal Bouabdallah, Gayane Tumyan, Muhit Özcan, Sergio Portino, Laura Fogliatto, Maria D Caballero and 19 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 163 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
163citing papers in PubMed, 2 pooled it
22.6field-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.

NCT01953692 phase1completednot on this map

A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2020Enrolled197ConditionsMyelodysplastic Syndrome, Multiple Myeloma, Hodgkin Lymphoma, Non-Hodgkin LymphomaArmsPembrolizumab, Lenalidomide 20 mg, Lenalidomide 25 mg
NCT02576990 phase2completednot on this map

A Phase II Study of Pembrolizumab (MK-3475) in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) or Relapsed or Refractory Richter Syndrome (rrRS)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2020Enrolled80ConditionsMediastinal Large B-cell Lymphoma, Richter SyndromeArmsPembrolizumab
3 · Its place in the literature

Who cites it

163 citing papers in PubMed, 2 syntheses or guidelines pooled it, 257 citations in OpenAlex.

  1. Pooled it
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  3. Trial
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  9. Pembrolizumab in relapsed or refractory Richter syndrome.British journal of haematology · 2020
    Trial
  10. Review
  11. Article
  12. Review
  13. Review
  14. Incidence of B-cell Malignancies in Patients with Lung Cancer Receiving PD-1 Blockade Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  15. Review
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103 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 19 institutions in 8 countries.

Philippe ArmandDana-Farber Cancer Institute, Boston, MA.
Scott RodigDana-Farber Cancer Institute, Boston, MA.
Vladimir MelnichenkoPirogov National Medical Surgical Center, Moscow, Russia.
Catherine ThieblemontAssistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Paris, France.
Kamal BouabdallahHôpital Haut-Levêque, Pessac, France.
Gayane TumyanN.N. Blokhin Russian Cancer Research Center, Moscow, Russia.
Muhit ÖzcanAnkara University Medical School, Ankara, Turkey.
Sergio PortinoClinica Alemana de Santiago, Santiago, Chile.
Laura FogliattoHospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.
Maria D CaballeroHospital Clínico de Salamanca, Salamanca, Spain.
Jan WalewskiMaria Sklodowska-Curie Institute Oncology Center, Warszawa, Poland.
Zafer GulbasAnadolu Medical Center, Gebze, Turkey.
Vincent RibragInstitut Gustave Roussy, Paris, France.
Beth ChristianThe Ohio State University Comprehensive Cancer Center, Columbus, OH.
Guilherme Fleury PeriniHospital Israelita Albert Einstein, Sao Paulo, Brazil.
Gilles SallesUniversite Claude Bernard Lyon, Lyon, France.
Jakub SvobodaUniversity of Pennsylvania, Philadelphia, PA.
Jasmine ZainCity of Hope, Duarte, CA.
Sanjay PatelBrigham & Women's Hospital, Boston, MA.
Pei-Hsuan ChenDana-Farber Cancer Institute, Boston, MA.
Azra H LigonBrigham & Women's Hospital, Boston, MA.
Jing OuyangDana-Farber Cancer Institute, Boston, MA.
Donna NeubergDana-Farber Cancer Institute, Boston, MA.
Robert ReddDana-Farber Cancer Institute, Boston, MA.
Arkendu ChatterjeeMerck & Co, Kenilworth, NJ.
Arun BalakumaranMerck & Co, Kenilworth, NJ.
Robert OrlowskiMerck & Co, Kenilworth, NJ.
Margaret ShippDana-Farber Cancer Institute, Boston, MA.
Pier Luigi ZinzaniInstitute of Hematology, Seràgnoli University of Bologna, Bologna, Italy.
Dana-Farber Cancer Institute · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USBrigham and Women's Hospital · USAnadolu University · TRAnkara University · TRCity of Hope · USClínica Alemana · CLHôpital Cardiologique du Haut-Lévêque · FRHôpital Saint-Louis · FRHospital de Clínicas de Porto Alegre · BRHospital Israelita Albert Einstein · BRInstitut Gustave Roussy · FRNational Medical and Surgical Center named after N.I. Pirogov · RURussian Cancer Research Center NN Blokhin · RUThe Maria Sklodowska-Curie National Research Institute of Oncology · PLThe Ohio State University · USUniversité Claude Bernard Lyon 1 · FRUniversity of Bologna · ITUniversity of Pennsylvania · US

Funding

VASCULAR, PULMONARY AND RENAL INJURYT32HL007627 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI GIMBRONE, MICHAEL A, MITCHELL, RICHARD N · 1985 to 2019
$12.7M
Targetable Immune Evasion Pathways in Hodgkin LymphomaR01CA161026 · NCI · DANA-FARBER CANCER INST · PI SHIPP, MARGARET A · 2011 to 2020
$4.0M
NCI NIH HHS R01 CA161026NHLBI NIH HHS T32 HL007627
6 · The paper itself

Abstract

purposePatients with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL) have a poor prognosis, and their treatment represents an urgent and unmet need. Because PMBCL is associated with genetic aberrations at 9p24 and overexpression of programmed cell death-1 (PD-1) ligands (PD-L1), it is hypothesized to be susceptible to PD-1 blockade.

methodsIn the phase IB KEYNOTE-013 (ClinicalTrials.gov identifier: NCT01953692) and phase II KEYNOTE-170 (ClinicalTrials.gov identifier: NCT02576990) studies, adults with rrPMBCL received pembrolizumab for up to 2 years or until disease progression or unacceptable toxicity. The primary end points were safety and objective response rate in KEYNOTE-013 and objective response rate in KEYNOTE-170. Secondary end points included duration of response, progression-free survival, overall survival, and safety. Exploratory end points included association between biomarkers and pembrolizumab activity.

resultsThe objective response rate was 48% (7 complete responses; 33%) among 21 patients in KEYNOTE-013 and 45% (7 complete responses; 13%) among 53 patients in KEYNOTE-170. After a median follow-up time of 29.1 months in KEYNOTE-013 and 12.5 months in KEYNOTE-170, the median duration of response was not reached in either study. No patient with complete response experienced progression, including 2 patients with complete response for at least 1 year off therapy. Treatment-related adverse events occurred in 24% of patients in KEYNOTE-013 and 23% of patients in KEYNOTE-170. There were no treatment-related deaths. Among 42 evaluable patients, the magnitude of the 9p24 gene abnormality was associated with PD-L1 expression, which was itself significantly associated with progression-free survival.

conclusionPembrolizumab is associated with high response rate, durable activity, and a manageable safety profile in patients with rrPMBCL.

Indexed as

Drug Resistance, NeoplasmNeoplasm Recurrence, LocalAdultAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalDisease ProgressionEuropeFemaleHumansLymphoma, B-CellMaleMediastinal NeoplasmsMiddle AgedProgression-Free SurvivalRisk AssessmentRisk FactorsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumab

Identifiers

PMID31609651
PMCPMC6881098
OpenAlexW2979952645

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.