Evidence map›Paper›PMID 39706335›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2025

Avelumab + axitinib versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma: final analysis of the phase III JAVELIN Renal 101 trial.

T K Choueiri, K Penkov, H Uemura, M T Campbell, S Pal, C Kollmannsberger, J L Lee, B Venugopal, A J M van den Eertwegh, S Negrier and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2025. 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 45 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

45 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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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

27 authors.

T K ChoueiriThe Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: toni_choueiri@dfci.harvard.edu.
K PenkovPrivate Medical Institution, Euromedservice, St. Petersburg, Russian Federation.
H UemuraDepartment of Urology, Kindai University Faculty of Medicine, Osakasayama, Japan.
M T CampbellDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA.
S PalCity of Hope, Duarte, USA.
C KollmannsbergerBC Cancer - Vancouver Centre, Vancouver, Canada.
J L LeeAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
B VenugopalBeatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.
A J M van den EertweghAmsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.
S NegrierUniversity of Lyon, Centre Léon Bérard, Lyon, France.
H GurneyDepartment of Clinical Medicine, Macquarie University, Sydney, Australia.
L AlbigesInstitut Gustave Roussy, Villejuif, France.
R BergerThe Chaim Sheba Medical Center, Ramat Gan, Israel.
J B A G HaanenNetherlands Cancer Institute, Amsterdam, the Netherlands.
V Oyervides JuárezHospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer, Monterrey, Mexico.
B I RiniVanderbilt-Ingram Cancer Center, Nashville, USA.
J LarkinRoyal Marsden NHS Foundation Trust, London, UK.
F NolèIstituto Europeo di Oncologia, Milan, Italy.
M SchmidingerMedical University of Vienna, Vienna, Austria.
M B AtkinsGeorgetown University Medical Center, Washington, USA.
Y TomitaDepartment of Urology, Niigata University Graduate School of Medicine, Niigata, Japan; Department of Molecular Oncology, Niigata University Graduate School of Medicine, Niigata, Japan.
B Ellers-LenzMerck Healthcare KGaA, Darmstadt, Germany.
J HoffmanEMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, USA.
R SandnerPfizer, Collegeville, USA.
J WangPfizer, Cambridge, USA.
A di PietroPfizer srl, Milan, Italy.
R J MotzerMemorial Sloan Kettering Cancer Center, New York, USA. Electronic address: motzerr@MSKCC.ORG.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI A. Heather Eliassen · 1985 to 2026
$330.6M
Treating the P13-Kinase/AKTP50CA101942 · NCI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Wanling Xie · 2003 to 2026
$53.4M
NCI NIH HHS P30 CA006516NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA101942
6 · The paper itself

Abstract

backgroundIn the phase III JAVELIN Renal 101 trial (NCT02684006), first-line treatment with avelumab + axitinib resulted in significantly longer progression-free survival (PFS) and a higher objective response rate (ORR) versus sunitinib in patients with advanced renal cell carcinoma (aRCC). We report the final analysis, including the primary analysis of overall survival (OS). PATIENTS AND

methodsPatients with untreated aRCC (any prognostic risk score) were enrolled. The primary endpoints were OS and PFS in the programmed death-ligand 1-positive (PD-L1+) population. ORR, duration of response, safety, and patient-reported outcomes (PROs) were also assessed.

resultsThe minimum follow-up was 68 months in all patients. The median OS with avelumab + axitinib versus sunitinib, respectively, was 43.2 months [95% confidence interval (CI) 36.5-51.7 months] versus 36.2 months (95% CI 29.8-44.2 months) in the PD-L1+ population [hazard ratio (HR) 0.86 (95% CI 0.701-1.057); P = 0.0755] and 44.8 months (95% CI 39.7-51.1 months) versus 38.9 months (95% CI 31.4-45.2 months) in the overall population [HR 0.88 (95% CI 0.749-1.039); P = 0.0669]. Investigator-assessed PFS remained prolonged with avelumab + axitinib versus sunitinib [5-year event-free rate in the overall population, 12.0% (95% CI 8.9% to 15.6%) versus 4.4% (95% CI 2.5% to 7.3%)]. ORR in the overall population was 59.7% (95% CI 55.0% to 64.3%) with avelumab + axitinib versus 32.0% (95% CI 27.7% to 36.5%) with sunitinib; duration of response was ≥5 years in 16.4% (95% CI 12.0% to 21.4%) versus 9.2% (95% CI 4.6% to 15.7%), respectively. Rates of grade ≥3 treatment-related adverse events were 66.8% versus 61.5%, respectively. PROs were similar between arms.

conclusionsJAVELIN Renal 101 provides the longest follow-up to date for immune checkpoint inhibitor + tyrosine kinase inhibitor combination treatment from a phase III trial in aRCC. OS analyses favored avelumab + axitinib versus sunitinib but did not reach statistical significance; subsequent treatment may have impacted results. Avelumab + axitinib provided long-term efficacy benefits versus sunitinib, including prolonged PFS, a nearly doubled ORR, and more durable responses, with a manageable long-term safety profile.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellKidney NeoplasmsAdultAgedAntibodies, Monoclonal, HumanizedAxitinibB7-H1 AntigenFemaleHumansMaleMiddle AgedProgression-Free SurvivalSunitinibAntibodies, Monoclonal, HumanizedavelumabAxitinibB7-H1 AntigenCD274 protein, humanSunitinibadvanced renal cell carcinomaavelumabaxitinibphase IIIsunitinib

Identifiers

PMID39706335
PMCPMC12184433

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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.