Evidence map›Paper›PMID 38102374›Full record

Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2024

Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial.

Miguel Ángel Climent, Carlos Álvarez, Rafael Morales, Pablo Maroto, Alejo Rodríguez-Vida, María José Méndez-Vidal, Xavier García Del Muro, Javier Puente, Nuria Láinez, Sergio Vázquez and 8 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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

18 authors at 16 institutions in 3 countries.

Miguel Ángel ClimentValencian Institute of Oncology, Valencia, Spain.
Carlos ÁlvarezHospital Universitario Central de Asturias, Oviedo, Spain.
Rafael MoralesVall d'Hebron University Hospital, Barcelona, Spain.
Pablo MarotoHospital Universitari de La Santa Creu I Sant Pau, Barcelona, Spain.
Alejo Rodríguez-VidaHospital del Mar-CIBERONC, IMIM Research Institute, Barcelona, Spain.
María José Méndez-VidalMaimonides Institute for Biomedical Research of Cordoba (IMIBIC), Reina Sofia University Hospital (HURS), Cordoba, Spain.
Xavier García Del MuroCatalan Institute of Oncology, Barcelona, Spain.
Javier PuenteHospital Universitario Clínico San Carlos, Madrid, Spain.
Nuria LáinezUniversity Hospital of Navarra, Pamplona, Spain.
Sergio VázquezHospital Universitario Lucus Augusti, Lugo, Spain.
Daniel CastellanoHospital 12 de Octubre, Madrid, Spain.
Carmen Gómez LangMerck S.L.U., an Affiliate of Merck KGaA, Madrid, Spain.
Jing WangPfizer, Cambridge, MA, USA.
Alessandra di PietroPfizer Srl, Milan, Italy.
Craig DavisPfizer Translational Oncology, La Jolla, CA, USA.
Belén Sanz-CastilloPfizer Oncology, Madrid, Spain.
M Victoria BolósPfizer Oncology, Madrid, Spain.
Begoña P ValderramaVirgen del Rocío University Hospital, Seville, Spain. bpvalderrama@gmail.com.ORCID http://orcid.org/0000-0003-0175-1263
Pfizer (Spain) · ESPfizer (United States) · USFundación Instituto Valenciano de Oncología · ESHospital Clínico San Carlos · ESHospital Del Mar · ESHospital de Sant Pau · ESHospital Universitario Central de Asturias · ESHospital Universitario Lucus Augusti · ESHospital Universitario Virgen del Rocío · ESInstitut Català d'Ornitologia · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESMerck (Spain) · ESPfizer (Italy) · ITResearch Institute Hospital 12 de Octubre · ESUniversidad de Navarra · ESVall d'Hebron Hospital Universitari · ES

Funding

Merck KGaA 10.13039/100009945
6 · The paper itself

Abstract

purposePost hoc analysis of the JAVELIN Bladder 100 trial of avelumab maintenance in locally advanced/metastatic urothelial carcinoma (la/mUC) to determine the interaction by programmed death ligand 1 (PD-L1) status for overall survival (OS), and additional analyses of survival per a different PD-L1 expression cutoff of ≥ 1% in tumor cells or immune cells (TC/IC).

methodsJAVELIN Bladder 100 data were used for the analysis of the interaction by PD-L1 status (per cutoff used in the trial) for OS and, additionally, OS and progression-free survival (PFS) analyses per a different ≥ 1% TC/IC PD-L1 expression cutoff (Ventana SP263 assay).

resultsNo significant interaction between treatment and PD-L1 status was observed for OS. Clinically meaningful and robust survival data were observed in favor of avelumab using the different ≥ 1% TC/IC PD-L1 expression cutoff.

conclusionsThese results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.

Indexed as

Antibodies, Monoclonal, HumanizedB7-H1 AntigenCarcinoma, Transitional CellUrinary Bladder NeoplasmsAgedAntineoplastic Agents, ImmunologicalFemaleHumansMaintenance ChemotherapyMaleMiddle AgedProgression-Free SurvivalSurvival RateAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalavelumabB7-H1 AntigenCD274 protein, humanAdvanced urothelial carcinomaAvelumabInteraction testMaintenance treatmentPD-L1

Identifiers

PMID38102374
PMCPMC11108865
OpenAlexW4389781325

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.