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    Avelumab plus axitinib as first-line therapy for advanced renal cell carcinoma: long-term results from the JAVELIN Renal 100 Phase Ib Trial

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    Authors
    Larkin, J.
    Oya, M.
    Martignoni, M.
    Thistlethwaite, Fiona C
    Nathan, P.
    Ornstein, M. C.
    Powles, T.
    Beckermann, K. E.
    Balar, A. V.
    McDermott, D.
    Gupta, S.
    Philips, G. K.
    Gordon, M. S.
    Uemura, H.
    Tomita, Y.
    Wang, J.
    Michelon, E.
    di Pietro, A.
    Choueiri, T. K.
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    Affiliation
    Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, UK
    Issue Date
    2022
    
    Metadata
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    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
    Citation
    Larkin J, Oya M, Martignoni M, Thistlethwaite F, Nathan P, Ornstein MC, et al. Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial. Oncologist. 2022 Dec 28. PubMed PMID: 36576173. Epub 2022/12/29. eng.
    Journal
    Oncologist
    URI
    http://hdl.handle.net/10541/625933
    DOI
    10.1093/oncolo/oyac243
    PubMed ID
    36576173
    Additional Links
    https://dx.doi.org/10.1093/oncolo/oyac243
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1093/oncolo/oyac243
    Scopus Count
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