2020
DOI: 10.1056/nejmoa2002788
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Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma

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Cited by 1,013 publications
(1,002 citation statements)
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References 36 publications
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“…Last but not least, results from IMvigor130 [31], DANUBE [32], Checkmate901, Keynote361 [33], NILE, and EV-302 phase III trials are expected to keep shaping the treatment landscape in aUC and impact the potential clinical applications of our risk score. For example, our score may not necessarily apply to the switch maintenance anti-PD-L1 setting, which is the new standard of care based on the Javelin Bladder 100 trial (with avelumab) [4]. Despite these limitations, our study developed a prognostic model using data from patients with aUC treated with ICIs as first-line therapy outside clinical trials, which can contribute to the emerging literature and be further validated in clinical trials.…”
Section: Discussionmentioning
confidence: 99%
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“…Last but not least, results from IMvigor130 [31], DANUBE [32], Checkmate901, Keynote361 [33], NILE, and EV-302 phase III trials are expected to keep shaping the treatment landscape in aUC and impact the potential clinical applications of our risk score. For example, our score may not necessarily apply to the switch maintenance anti-PD-L1 setting, which is the new standard of care based on the Javelin Bladder 100 trial (with avelumab) [4]. Despite these limitations, our study developed a prognostic model using data from patients with aUC treated with ICIs as first-line therapy outside clinical trials, which can contribute to the emerging literature and be further validated in clinical trials.…”
Section: Discussionmentioning
confidence: 99%
“…Since 2016, five immune checkpoint inhibitors (ICIs) targeting programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) have been approved by the Food and Drug Administration (FDA) for the treatment of advanced urothelial cancer (aUC) [2]. Pembrolizumab (anti--PD-1) and avelumab (anti-PD-L1) improved overall survival (OS) in the platinum-refractory and switch maintenance (after first-line platinum chemotherapy) settings, respectively [3,4]. Anti-PD-(L)1 ICIs also have a role in the first-line setting for cisplatin-unfit patients with high PD-L1 tumors or for platinum (cisplatin and carboplatin)-unfit patients [2].…”
Section: Introductionmentioning
confidence: 99%
“…The other pattern involves switching from chemotherapy to pembrolizumab once a certain number of courses have been reached, even if the chemotherapy did not lead to progressive disease. This pattern is almost identical to the "switch maintenance" therapy approach used in the JAVELIN Bladder 100 clinical trial design with the PD-L1 inhibitor avelumab [12]. The criteria in that study were eligible patients with unresectable locally advanced or metastatic UC without disease progression after four to six cycles of gemcitabine with either cisplatin or carboplatin.…”
Section: Discussionmentioning
confidence: 99%
“…The remaining four agents (nivolumab, atezolizumab, durvalumab and avelumab) were approved based on single arm studies versus historical records [ 29 ]. The recently published JAVELIN Bladder 100 trial showed that the addition of avelumab as maintenance therapy following completion of first line standard of care chemotherapy had significantly improved OS irrespective of PD-L1 status [ 30 ].…”
Section: Ici Therapy In Nsclc Melanoma Rcc and Urothelial/bladdementioning
confidence: 99%