dc.contributor.author | Larkin, J | |
dc.contributor.author | Oya, M | |
dc.contributor.author | Martignoni, M | |
dc.contributor.author | Thistlethwaite, F | |
dc.contributor.author | Nathan, P | |
dc.contributor.author | Ornstein, MC | |
dc.contributor.author | Powles, T | |
dc.contributor.author | Beckermann, KE | |
dc.contributor.author | Balar, AV | |
dc.contributor.author | McDermott, D | |
dc.contributor.author | Gupta, S | |
dc.contributor.author | Philips, GK | |
dc.contributor.author | Gordon, MS | |
dc.contributor.author | Uemura, H | |
dc.contributor.author | Tomita, Y | |
dc.contributor.author | Wang, J | |
dc.contributor.author | Michelon, E | |
dc.contributor.author | di Pietro, A | |
dc.contributor.author | Choueiri, TK | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2023-04-12T09:54:45Z | |
dc.date.available | 2023-04-12T09:54:45Z | |
dc.date.issued | 2022-12-28 | |
dc.identifier | 6961606 | |
dc.identifier.citation | The Oncologist, 2022, pp. oyac243 - | en_US |
dc.identifier.issn | 1083-7159 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5740 | |
dc.identifier.eissn | 1549-490X | |
dc.identifier.eissn | 1549-490X | |
dc.identifier.doi | 10.1093/oncolo/oyac243 | |
dc.description.abstract | BACKGROUND: 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 (Clinicaltrials.gov NCT02493751). | |
dc.format | Print-Electronic | |
dc.format.extent | oyac243 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | OXFORD UNIV PRESS | en_US |
dc.relation.ispartof | The Oncologist | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0 | en_US |
dc.subject | clinical trials as topic | |
dc.subject | drug therapy | |
dc.subject | immunotherapy | |
dc.subject | kidney neoplasms | |
dc.title | Avelumab 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.type | Journal Article | |
dcterms.dateAccepted | 2022-10-06 | |
dc.date.updated | 2023-04-12T09:54:20Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1093/oncolo/oyac243 | en_US |
rioxxterms.licenseref.startdate | 2022-12-28 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36576173 | |
pubs.organisational-group | /ICR | |
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-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1093/oncolo/oyac243 | |
dc.contributor.icrauthor | Larkin, James | |
icr.provenance | Deposited by Mr Arek Surman on 2023-04-12. Deposit type is initial. No. of files: 1. Files: oyac243.pdf | |