Evidence map›Paper›PMID 32895571›Full record

Trial reportNature medicine2020

Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial.

Robert J Motzer, Paul B Robbins, Thomas Powles, Laurence Albiges, John B Haanen, James Larkin, Xinmeng Jasmine Mu, Keith A Ching, Motohide Uemura, Sumanta K Pal and 13 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02684006 (A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB), which is not on this map. Cited by 318 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
318citing papers in PubMed, 7 pooled it
40.5field-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.

NCT02684006 phase3completednot on this map

A phase 3, multinational, randomized, open-label, parallel-arm study of avelumab (msb0010718c) in combination with axitinib (inlyta(registered)) versus sunitinib (sutent(registered)) monotherapy in the first-line treatment of patients with advanced renal cell carcinoma

TypeinterventionalSponsorPfizerRan2016 to 2024Enrolled886ConditionsRenal Cell CancerArmsAvelumab (MSB0010718C), Axitinib (AG-013736), Sunitinib
3 · Its place in the literature

Who cites it

318 citing papers in PubMed, 7 syntheses or guidelines pooled it, 506 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. SEOM SOGUG clinical guideline for treatment of kidney cancer (2022).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Guideline
  7. Pooled it
  8. Trial
  9. Axitinib plus Avelumab in Recurrent/Metastatic Adenoid Cystic Carcinoma: Biomarker Analysis and Updated Results of the Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Phase II Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  18. Review
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 13 institutions in 7 countries.

Robert J Motzer *Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA. motzerr@mskcc.org.ORCID http://orcid.org/0000-0001-6925-2327
Paul B Robbins *Translational Oncology, Pfizer, San Diego, CA, USA.
Thomas PowlesDepartment of Genitourinary Oncology, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK.
Laurence AlbigesDepartment of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
John B HaanenDivision of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.ORCID http://orcid.org/0000-0001-5884-7704
James LarkinConsultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, UK.
Xinmeng Jasmine MuComputational Biology, Pfizer, San Diego, CA, USA.
Keith A ChingComputational Biology, Pfizer, San Diego, CA, USA.
Motohide UemuraGraduate School of Medicine, Osaka University Hospital, Osaka, Japan.
Sumanta K PalDepartment of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Boris AlekseevDeputy Director for Science, Moscow Scientific Research Oncology Institute, Moscow, Russian Federation.
Gwenaelle GravisDepartment of Medical Oncology, Institut Paoli Calmettes, Marseille, France.
Matthew T CampbellDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0003-1915-4491
Konstantin PenkovPrivate Medical Institution, Euromedservice, St. Petersburg, Russian Federation.
Jae Lyun LeeDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Subramanian HariharanOncology, Pfizer, New York, NY, USA.
Xiao WangComputational Biology, Pfizer, San Diego, CA, USA.
Weidong ZhangBiostatistics, Pfizer, Cambridge, MA, USA.
Jing WangBiostatistics, Pfizer, Cambridge, MA, USA.
Aleksander ChudnovskyOncology, Pfizer, Cambridge, MA, USA.
Alessandra di PietroImmuno-Oncology, Pfizer, Milan, Italy.
Amber C DonahueTranslational Oncology, Pfizer, La Jolla, CA, USA.ORCID http://orcid.org/0000-0003-2846-1119
Toni K ChoueiriDepartment of Medical Oncology, The Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA, USA. toni_choueiri@dfci.harvard.edu.ORCID http://orcid.org/0000-0002-9201-3217
Pfizer (United States) · USBrigham and Women's Hospital · USCity of Hope · USInstitut Gustave Roussy · FRInstitut Paoli-Calmettes · FRMemorial Sloan Kettering Cancer Center · USOsaka University Hospital · JPPfizer (Italy) · ITRoyal Marsden NHS Foundation Trust · GBSt Bartholomew's Hospital · GBThe Netherlands Cancer Institute · NLThe University of Texas MD Anderson Cancer Center · USUlsan College · KR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

We report on molecular analyses of baseline tumor samples from the phase 3 JAVELIN Renal 101 trial (n = 886; NCT02684006 ), which demonstrated significantly prolonged progression-free survival (PFS) with first-line avelumab + axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We found that neither expression of the commonly assessed biomarker programmed cell death ligand 1 (PD-L1) nor tumor mutational burden differentiated PFS in either study arm. Similarly, the presence of FcɣR single nucleotide polymorphisms was unimpactful. We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types. These findings provide insight into the determinants of response to combined PD-1/PD-L1 and angiogenic pathway inhibition and may aid in the development of strategies for improved patient care in aRCC.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibBiomarkers, TumorCarcinoma, Renal CellFemaleGene Expression Regulation, NeoplasticHumansKidneyMaleMiddle AgedProgression-Free SurvivalAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabAxitinibBiomarkers, TumorSunitinib

Identifiers

PMID32895571
PMCPMC8493486
OpenAlexW3083058958

What OpenQuestion holds

Textmetadata
LicenceTDM
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.