{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T19:52:25Z","timestamp":1785786745595,"version":"3.56.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2022,12,28]],"date-time":"2022-12-28T00:00:00Z","timestamp":1672185600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["10.13039\/100009945"],"award-info":[{"award-number":["10.13039\/100009945"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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 \u22653 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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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).<\/jats:p><\/jats:sec>","DOI":"10.1093\/oncolo\/oyac243","type":"journal-article","created":{"date-parts":[[2022,12,28]],"date-time":"2022-12-28T12:21:17Z","timestamp":1672230077000},"page":"333-340","source":"Crossref","is-referenced-by-count":16,"title":["Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5569-9523","authenticated-orcid":false,"given":"James","family":"Larkin","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Royal Marsden NHS Foundation Trust , London , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mototsugu","family":"Oya","sequence":"additional","affiliation":[{"name":"Department of Urology, Keio University Hospital , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcella","family":"Martignoni","sequence":"additional","affiliation":[{"name":"Clinical Development and Operations, Pfizer , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiona","family":"Thistlethwaite","sequence":"additional","affiliation":[{"name":"The Christie NHS Foundation Trust, Manchester, UK; Faculty of Biology, Medicine and Health, University of Manchester , Manchester , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Nathan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Mount Vernon Cancer Centre , Northwood , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moshe C","family":"Ornstein","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Cleveland Clinic , Cleveland, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Powles","sequence":"additional","affiliation":[{"name":"Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew\u2019s Hospital , London , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn E","family":"Beckermann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Vanderbilt University Medical Center , Nashville, TN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arjun V","family":"Balar","sequence":"additional","affiliation":[{"name":"Department of Medicine, Perlmutter Cancer Center at NYU Langone Health , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"McDermott","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Beth Israel Deaconess Medical Center , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumati","family":"Gupta","sequence":"additional","affiliation":[{"name":"Department of Medicine, Huntsman Cancer Institute, University of Utah , Salt Lake City, UT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George K","family":"Philips","sequence":"additional","affiliation":[{"name":"Department of Medicine, Georgetown University Medical Center , Washington, DC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S","family":"Gordon","sequence":"additional","affiliation":[{"name":"Division of Cancer Research, HonorHealth Research Institute , Scottsdale, AZ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotsugu","family":"Uemura","sequence":"additional","affiliation":[{"name":"Department of Medicine, Kindai University Hospital , Osaka , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7465-9591","authenticated-orcid":false,"given":"Yoshihiko","family":"Tomita","sequence":"additional","affiliation":[{"name":"Department of Urology, Graduate School of Medical and Dental Sciences, Niigata University , Niigata , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Wang","sequence":"additional","affiliation":[{"name":"Biostatistics, Pfizer , Cambridge, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabete","family":"Michelon","sequence":"additional","affiliation":[{"name":"Safety Surveillance & Risk Management , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"di Pietro","sequence":"additional","affiliation":[{"name":"Global Product Development, Pfizer , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toni K","family":"Choueiri","sequence":"additional","affiliation":[{"name":"Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women\u2019s Hospital and Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,12,28]]},"reference":[{"issue":"3","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"79","DOI":"10.14740\/wjon1279","article-title":"Epidemiology of renal cell carcinoma","volume":"11","author":"Padala","year":"2020","journal-title":"World J Oncol"},{"issue":"4","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1056\/NEJMra1601333","article-title":"Systemic therapy for metastatic renal-cell carcinoma","volume":"376","author":"Choueiri","year":"2017","journal-title":"N Engl J Med"},{"key":"2023040615581761000_","volume-title":"Prescribing information","author":"Inlyta (Axitinib).","year":"2020"},{"issue":"1","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1186\/s40425-019-0746-2","article-title":"Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase 1b results from the JAVELIN Solid Tumor trial","volume":"7","author":"Vaishampayan","year":"2019","journal-title":"J ImmunoTher Cancer"},{"issue":"21","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"2627","DOI":"10.1042\/CS20160894","article-title":"Immune checkpoint inhibitors in renal cell carcinoma","volume":"131","author":"Ross","year":"2017","journal-title":"Clin Sci (Lond)"},{"key":"2023040615581761000_","author":"National Cancer Institute."},{"key":"2023040615581761000_","volume-title":"Prescribing information","author":"Bavencio (avelumab).","year":"2022"},{"key":"2023040615581761000_","volume-title":"Kidney Cancer. V3","author":"NCCN Clinical Practice Guidelines in Oncology.","year":"2022"},{"issue":"5","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"706","DOI":"10.1093\/annonc\/mdz056","article-title":"Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up","volume":"30","author":"Escudier","year":"2019","journal-title":"Ann Oncol"},{"issue":"4","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1016\/S1470-2045(18)30107-4","article-title":"Preliminary results for avelumab plus axitinib as first-line therapy in patients with advanced clear-cell renal-cell carcinoma (JAVELIN Renal 100): an open-label, dose-finding and dose-expansion, phase 1b trial","volume":"19","author":"Choueiri","year":"2018","journal-title":"Lancet Oncol"},{"issue":"12","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1056\/NEJMoa1816047","article-title":"Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma","volume":"380","author":"Motzer","year":"2019","journal-title":"N Engl J Med"},{"issue":"8","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"1030","DOI":"10.1016\/j.annonc.2020.04.010","article-title":"Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma","volume":"31","author":"Choueiri","year":"2020","journal-title":"Ann Oncol"},{"key":"2023040615581761000_","volume-title":"Summary of product characteristics","author":"Bavencio (avelumab).","year":"2022"},{"issue":"suppl 2","key":"2023040615581761000_","first-page":"51(abstract 20)","article-title":"Efficacy of avelumab + axitinib (A + Ax) vs sunitinib (S) by IMDC risk group in advanced renal cell carcinoma (aRCC): extended follow-up results from JAVELIN Renal 101","volume":"17","author":"Haanen","year":"2021","journal-title":"Asia Pac J Clin Oncol"},{"key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.ejca.2020.12.009","article-title":"Axitinib plus pembrolizumab in patients with advanced renal-cell carcinoma: long-term efficacy and safety from a phase Ib trial","volume":"145","author":"Atkins","year":"2021","journal-title":"Eur J Cancer"},{"issue":"15 suppl","key":"2023040615581761000_","article-title":"Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): results from 42-month follow-up of KEYNOTE-426","volume":"39","author":"Rini","year":"2021","journal-title":"J Clin Oncol"},{"issue":"3","key":"2023040615581761000_","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1093\/jnci\/djaa064","article-title":"Summary from the first Kidney Cancer Research Summit, September 12-13, 2019: a focus on translational research","volume":"113","author":"Choueiri","year":"2021","journal-title":"J Natl Cancer Inst"}],"container-title":["The Oncologist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/28\/4\/333\/49789529\/oyac243.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/28\/4\/333\/49789529\/oyac243.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,30]],"date-time":"2023-11-30T21:51:25Z","timestamp":1701381085000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/oncolo\/article\/28\/4\/333\/6961606"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,28]]},"references-count":17,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2022,12,28]]},"published-print":{"date-parts":[[2023,4,6]]}},"URL":"https:\/\/doi.org\/10.1093\/oncolo\/oyac243","relation":{},"ISSN":["1083-7159","1549-490X"],"issn-type":[{"value":"1083-7159","type":"print"},{"value":"1549-490X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,4,1]]},"published":{"date-parts":[[2022,12,28]]}}}