Evidence map›Paper›PMID 33901870›Full record

Trial reportESMO open2021

Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial.

T K Choueiri, J Larkin, S Pal, R J Motzer, B I Rini, B Venugopal, B Alekseev, H Miyake, G Gravis, M A Bilen and 9 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% 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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Sarcomatoid Renal Cell Carcinoma: A Clinical Review.Diagnostics (Basel, Switzerland) · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. Immune Checkpoint Inhibitors in Clear Cell Renal Cell Carcinoma (ccRCC).International journal of molecular sciences · 2025
    Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Renal Cell Carcinoma of Variant Histology: New Biologic Understanding Leads to Therapeutic Advances.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2024
    Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 13 institutions in 6 countries.

T K ChoueiriDepartment of Medical Oncology, The Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, USA. Electronic address: toni_choueiri@dfci.harvard.edu.
J LarkinRenal and Skin Units, The Royal Marsden NHS Foundation Trust, Chelsea, London, UK.
S PalDepartment of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, USA.
R J MotzerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
B I RiniDepartment of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, USA.
B VenugopalInstitute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, Scotland, UK.
B AlekseevP. Hertsen Moscow Oncology Research Institute, Moscow, Russia.
H MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.
G GravisDepartment of Medical Oncology, Institut Paoli-Calmettes, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France.
M A BilenDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, USA.
S HariharanOncology, Pfizer, New York, USA.
A ChudnovskyOncology, Pfizer, Cambridge, USA.
K A ChingComputational Biology, Pfizer, San Diego, USA.
X J MuComputational Biology, Pfizer, San Diego, USA.
M MarianiImmuno-Oncology, Pfizer, Milan, Lombardia, Italy.
P B RobbinsTranslational Oncology, Pfizer, San Diego, USA.
B HuangBiostatistics, Pfizer, Groton, USA.
A di PietroImmuno-Oncology, Pfizer, Milan, Lombardia, Italy.
L AlbigesDepartment of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
Pfizer (United States) · USPfizer (Italy) · ITAix-Marseille Université · FRCity of Hope · USDana-Farber Cancer Institute · USEmory University · USHamamatsu University School of Medicine · JPInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USP.A. Hertzen Moscow Oncology Research Institute · RURoyal Marsden NHS Foundation Trust · GBUniversity of Glasgow · GBVanderbilt University Medical Center · US

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

backgroundAmong patients with advanced renal cell carcinoma (RCC), those with sarcomatoid histology (sRCC) have the poorest prognosis. This analysis assessed the efficacy of avelumab plus axitinib versus sunitinib in patients with treatment-naive advanced sRCC.

methodsThe randomized, open-label, multicenter, phase III JAVELIN Renal 101 trial (NCT02684006) enrolled patients with treatment-naive advanced RCC. Patients were randomized 1 : 1 to receive either avelumab plus axitinib or sunitinib following standard doses and schedules. Assessments in this post hoc analysis of patients with sRCC included efficacy (including progression-free survival) and biomarker analyses.

resultsA total of 108 patients had sarcomatoid histology and were included in this post hoc analysis; 47 patients in the avelumab plus axitinib arm and 61 in the sunitinib arm. Patients in the avelumab plus axitinib arm had improved progression-free survival [stratified hazard ratio, 0.57 (95% confidence interval, 0.325-1.003)] and a higher objective response rate (46.8% versus 21.3%; complete response in 4.3% versus 0%) versus those in the sunitinib arm. Correlative gene expression analyses of patients with sRCC showed enrichment of gene pathway scores for cancer-associated fibroblasts and regulatory T cells, CD274 and CD8A expression, and tumors with The Cancer Genome Atlas m3 classification.

conclusionsIn this subgroup analysis of JAVELIN Renal 101, patients with sRCC in the avelumab plus axitinib arm had improved efficacy outcomes versus those in the sunitinib arm. Correlative analyses provide insight into this subtype of RCC and suggest that avelumab plus axitinib may increase the chance of overcoming the aggressive features of sRCC.

Indexed as

AxitinibCarcinoma, Renal CellKidney NeoplasmsSunitinibAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansAntibodies, Monoclonal, HumanizedavelumabAxitinibSunitinibavelumabaxitinibJAVELIN Renal 101renal cell carcinomasarcomatoid

Identifiers

PMID33901870
PMCPMC8099757
OpenAlexW3157616267

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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.