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dc.contributor.authorLarkin, J
dc.contributor.authorOya, M
dc.contributor.authorMartignoni, M
dc.contributor.authorThistlethwaite, F
dc.contributor.authorNathan, P
dc.contributor.authorOrnstein, MC
dc.contributor.authorPowles, T
dc.contributor.authorBeckermann, KE
dc.contributor.authorBalar, AV
dc.contributor.authorMcDermott, D
dc.contributor.authorGupta, S
dc.contributor.authorPhilips, GK
dc.contributor.authorGordon, MS
dc.contributor.authorUemura, H
dc.contributor.authorTomita, Y
dc.contributor.authorWang, J
dc.contributor.authorMichelon, E
dc.contributor.authordi Pietro, A
dc.contributor.authorChoueiri, TK
dc.identifier.citationThe Oncologist, 2022, pp. oyac243 -en_US
dc.description.abstractBACKGROUND: Progression-free survival was significantly longer in patients who received avelumab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma (aRCC) in a randomized phase III trial. We report long-term safety and efficacy of avelumab plus axitinib as first-line treatment for patients with aRCC from the JAVELIN Renal 100 phase Ib trial (NCT02493751). MATERIALS AND METHODS: In this open-label, multicenter, phase Ib study, patients with untreated aRCC received avelumab 10 mg/kg every 2 weeks plus axitinib 5 mg twice daily or with axitinib for 7 days followed by avelumab plus axitinib. Safety and efficacy were assessed in all patients receiving at least one dose of avelumab or axitinib. RESULTS: Overall, 55 patients were enrolled and treated. Median follow-up was 55.7 months (95% CI, 54.5-58.7). Treatment-related adverse events of any grade or grade ≥3 occurred in 54 (98.2%) and 34 (61.8%) patients, respectively. The confirmed objective response rate was 60.0% (95% CI, 45.9-73.0), including complete response in 10.9% of patients. Median duration of response was 35.9 months (95% CI, 12.7-52.9); the probability of response was 65.8% (95% CI, 46.7-79.4) at 2 years. Median progression-free survival was 8.3 months (95% CI, 5.3-32.0). Median overall survival was not reached (95% CI, 40.8-not estimable); the 5-year overall survival rate was 57.3% (95% CI, 41.2-70.5). CONCLUSION: Five-year follow-up for combination treatment with avelumab plus axitinib in previously untreated patients with aRCC showed long-term clinical activity with no new safety signals, supporting use of this regimen within its approved indication in clinical practice ( NCT02493751).
dc.format.extentoyac243 -
dc.publisherOXFORD UNIV PRESSen_US
dc.relation.ispartofThe Oncologist
dc.subjectclinical trials as topic
dc.subjectdrug therapy
dc.subjectkidney neoplasms
dc.titleAvelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.publication-statusPublished online
dc.contributor.icrauthorLarkin, James
icr.provenanceDeposited by Mr Arek Surman on 2023-04-12. Deposit type is initial. No. of files: 1. Files: oyac243.pdf

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