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.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023 Apr 18 [Epub ahead of print]
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
Barts Cancer Institute, Experimental Cancer Medicine Center, Queen Mary University of London, St Bartholomew's Hospital, London, United Kingdom., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni, Italy., Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain., Department of Clinical Medicine, Macquarie University, Sydney, New South Wales, Australia., Department of Pelvic Cancer, Genitourinary Oncology Unit, Karolinska University Hospital, Solna, Sweden., Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France., Princess Margaret Cancer Center, University Health Network, Toronto, Ontario, Canada., Englander Institute for Precision Medicine, Weill Cornell Medicine, Hematology/Oncology, Meyer Cancer Center, New York, NY., Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA., Inova Schar Cancer Institute, Fairfax, VA., Pfizer, Cambridge, MA., Pfizer, Groton, CT., Pfizer srl, Milano, Italy., University of Washington, Fred Hutchinson Cancer Center, Seattle, WA.