Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ‰2 Years of Follow-Up

Thomas Powles, Se Hoon Park, Claudia Caserta, Begoña P. Valderrama, Howard Gurney, Anders Ullén, Yohann Loriot, Srikala S. Sridhar, Cora N. Sternberg, Joaquim Bellmunt, Jeanny B. Aragon-Ching, Jing Wang, Bo Huang, Robert J. Laliberte, Alessandra Di Pietro, Petros Grivas

    Résultats de recherche: Contribution à un journalArticleRevue par des pairs

    53 Citations (Scopus)

    Résumé

    Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Initial results from the phase III JAVELIN Bladder 100 trial (ClinicalTrials.gov identifier: NCT02603432) showed that avelumab first-line (1L) maintenance plus best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) versus BSC alone in patients with advanced urothelial carcinoma (aUC) who were progression-free after 1L platinum-containing chemotherapy. Avelumab 1L maintenance treatment is now a standard of care for aUC. Here, we report updated data with ‰ 2 years of follow-up in all patients, including OS (primary end point), PFS, safety, and additional novel analyses. Patients were randomly assigned 1:1 to receive avelumab plus BSC (n = 350) or BSC alone (n = 350). At data cutoff (June 4, 2021), median follow-up was 38.0 months and 39.6 months, respectively; 67 patients (19.5%) had received ‰2 years of avelumab treatment. OS remained longer with avelumab plus BSC versus BSC alone in all patients (hazard ratio, 0.76 [95% CI, 0.63 to 0.91]; 2-sided P =.0036). Investigator-assessed PFS analyses also favored avelumab. Longer-term safety was consistent with previous analyses; no new safety signals were identified with longer treatment duration. In conclusion, longer-term follow-up continues to show clinically meaningful efficacy benefits with avelumab 1L maintenance plus BSC versus BSC alone in patients with aUC. An interactive visualization of data reported in this article is available.

    langue originaleAnglais
    Pages (de - à)3486-3492
    Nombre de pages7
    journalJournal of Clinical Oncology
    Volume41
    Numéro de publication19
    Les DOIs
    étatPublié - 1 juil. 2023

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