{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T10:51:05Z","timestamp":1791888665092,"version":"4.3.4"},"reference-count":33,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2020,10,9]],"date-time":"2020-10-09T00:00:00Z","timestamp":1602201600000},"content-version":"unspecified","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009945","name":"Merck KGaA","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009945","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2020,8,18]]},"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Anti-programmed cell death ligand 1 (PD-L1)\/programmed cell death 1 antibodies have shown clinical activity in platinum-treated metastatic urothelial carcinoma, resulting in regulatory approval of several agents, including avelumab (anti-PD-L1). We report \u22652-year follow-up data for avelumab treatment and exploratory subgroup analyses in patients with urothelial carcinoma.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients with previously treated advanced\/metastatic urothelial carcinoma, pooled from two cohorts of the phase Ib JAVELIN Solid Tumor trial, received avelumab 10\u2009mg\/kg every 2 weeks until disease progression, unacceptable toxicity or withdrawal. End points included best overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety. Post hoc analyses included objective response rates (ORRs) in subgroups defined by established high-risk\/poor-prognosis characteristics and association between time to response and outcome.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>249 patients received avelumab; efficacy was assessed in 242 postplatinum patients. Median follow-up was 31.9 months (range 24\u201343), and median treatment duration was 2.8 months (range 0.5\u201342.8). The confirmed ORR was 16.5% (95% CI 12.1% to 21.8%; complete response in 4.1% and partial response in 12.4%). Median duration of response was 20.5 months (95%\u2009CI 9.7 months to not estimable). Median PFS was 1.6 months (95%\u2009CI 1.4 to 2.7 months) and the 12-month PFS rate was 16.8% (95% CI 11.9% to 22.4%). Median OS was 7.0 months (95%\u2009CI 5.9 to 8.5 months) and the 24-month OS rate was 20.1% (95% CI 15.2% to 25.4%). In post hoc exploratory analyses, avelumab showed antitumor activity in high-risk subgroups, including elderly patients and those with renal insufficiency or upper tract disease; ORRs were numerically lower in patients with liver metastases or low albumin levels. Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95%\u2009CI 18.9 months to not estimable) vs 7.1 months (95%\u2009CI 5.2 to 9.0 months)). Safety findings were consistent with previously reported 6-month analyses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>After \u22652 years of follow-up, avelumab showed prolonged efficacy and acceptable safety in patients with platinum-treated advanced\/metastatic urothelial carcinoma, including high-risk subgroups. Survival appeared longer in patients who responded within 3 months. Long-term safety findings were consistent with earlier reports with avelumab treatment in this patient population.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2020-001246","type":"journal-article","created":{"date-parts":[[2020,10,9]],"date-time":"2020-10-09T17:46:11Z","timestamp":1602265571000},"page":"e001246","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":70,"title":["Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct01772004","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02603432","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9409-1836","authenticated-orcid":false,"given":"Andrea B","family":"Apolo","sequence":"first","affiliation":[{"name":"Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A","family":"Ellerton","sequence":"additional","affiliation":[{"name":"Nevada Cancer Research Foundation, Las Vegas, Nevada, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey R","family":"Infante","sequence":"additional","affiliation":[{"name":"Sarah Cannon Research Institute, Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish","family":"Agrawal","sequence":"additional","affiliation":[{"name":"Associates in Oncology, Rockville, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S","family":"Gordon","sequence":"additional","affiliation":[{"name":"HonorHealth Research Institute, Scottsdale, Arizona, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raid","family":"Aljumaily","sequence":"additional","affiliation":[{"name":"Sarah Cannon Research Institute, Nashville, Tennessee, USA"},{"name":"Hematology\/Oncology, The University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodore","family":"Gourdin","sequence":"additional","affiliation":[{"name":"Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luc","family":"Dirix","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sint-Augustinus Hospital Oncology Centre, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keun-Wook","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew H","family":"Taylor","sequence":"additional","affiliation":[{"name":"Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Sch\u00f6ffski","sequence":"additional","affiliation":[{"name":"Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium"},{"name":"Laboratory of Experimental Oncology, KU Leuven, Leuven Cancer Institute, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ding","family":"Wang","sequence":"additional","affiliation":[{"name":"Henry Ford Cancer Institute, Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9455-6744","authenticated-orcid":false,"given":"Alain","family":"Ravaud","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliane","family":"Manitz","sequence":"additional","affiliation":[{"name":"EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; 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