Evidence map›Paper›PMID 32339648›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2020

Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.

T K Choueiri, R J Motzer, B I Rini, J Haanen, M T Campbell, B Venugopal, C Kollmannsberger, G Gravis-Mescam, M Uemura, J L Lee and 15 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 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 245 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
245citing papers in PubMed, 15 pooled it
41.4field-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

245 citing papers in PubMed, 15 syntheses or guidelines pooled it, 454 citations in OpenAlex.

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  15. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
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  17. Randomized phase II dose comparison LITESPARK-013 study of belzutifan in patients with advanced clear cell renal cell carcinoma.Annals of oncology : official journal of the European Society for Medical Oncology · 2024
    Trial
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185 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 19 institutions in 11 countries.

T K ChoueiriLank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, USA. Electronic address: toni_choueiri@dcfi.harvard.edu.
R J MotzerMemorial Sloan Kettering Cancer Center, New York, USA.
B I RiniCleveland Clinic, Cleveland, USA.
J HaanenNetherlands Cancer Institute, Amsterdam, The Netherlands.
M T CampbellThe University of Texas MD Anderson Cancer Center, Houston, USA.
B VenugopalUniversity of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK.
C KollmannsbergerBritish Columbia Cancer Agency, Vancouver Centre, Vancouver, Canada.
G Gravis-MescamInstitut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France.
M UemuraOsaka University Hospital, Osaka, Japan.
J L LeeUniversity of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
M-O GrimmJena University Hospital, Department of Urology, Jena, Germany.
H GurneyMacquarie University, Sydney, Australia.
M SchmidingerClinical Division of Oncology, Department of Medicine I Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
J LarkinRoyal Marsden NHS Foundation Trust, London, UK.
M B AtkinsGeorgetown University Medical Center, Washington, DC.
S K PalCity of Hope National Medical Center, Duarte, USA.
J WangPfizer, Cambridge, USA.
M MarianiPfizer Italia SRL, Milan, Italy.
S KrishnaswamiPfizer, Groton, USA.
P CisloPfizer, New York, USA.
A ChudnovskyPfizer, Cambridge, USA.
C FowstPfizer Italia SRL, Milan, Italy.
B HuangPfizer, Groton, USA.
A di PietroPfizer Italia SRL, Milan, Italy.
L AlbigesInstitut Gustave Roussy, Villejuif, France.
Pfizer (United States) · USPfizer (Italy) · ITAsan Medical Center · KRBC Cancer Agency · CACentre National de la Recherche Scientifique · FRCity Of Hope National Medical Center · USCleveland Clinic · USComprehensive Cancer Center Vienna · ATDana-Farber Cancer Institute · USGeorgetown University · USInstitut Gustave Roussy · FRJena University Hospital · DEMacquarie University · AUMemorial Sloan Kettering Cancer Center · USOsaka University Hospital · JPRoyal Marsden NHS Foundation Trust · GBThe Netherlands Cancer Institute · NLThe University of Texas MD Anderson Cancer Center · USUniversity of Glasgow · GB

Funding

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

Abstract

backgroundThe phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis. PATIENTS AND

methodsTreatment-naive patients with aRCC were randomized (1 : 1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were PFS and overall survival (OS) among patients with programmed death ligand 1-positive (PD-L1+) tumors. Key secondary end points were OS and PFS in the overall population.

resultsOf 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cut-off 28 January 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm {PD-L1+ population: hazard ratio (HR) 0.62 [95% confidence interval (CI) 0.490-0.777]}; one-sided P < 0.0001; median 13.8 (95% CI 10.1-20.7) versus 7.0 months (95% CI 5.7-9.6); overall population: HR 0.69 (95% CI 0.574-0.825); one-sided P < 0.0001; median 13.3 (95% CI 11.1-15.3) versus 8.0 months (95% CI 6.7-9.8)]. OS data were immature [PD-L1+ population: HR 0.828 (95% CI 0.596-1.151); one-sided P = 0.1301; overall population: HR 0.796 (95% CI 0.616-1.027); one-sided P = 0.0392].

conclusionAmong patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS versus sunitinib; OS data were still immature. CLINICAL TRIAL NUMBER: NCT02684006.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAntibodies, Monoclonal, HumanizedAxitinibHumansSunitinibAntibodies, Monoclonal, HumanizedavelumabAxitinibSunitinibavelumabaxitinibimmune checkpoint inhibitorPD-L1phase 3renal cell carcinoma

Identifiers

PMID32339648
PMCPMC8436592
OpenAlexW3018979351

What OpenQuestion holds

Textmetadata
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.