Findings from the JAVELIN Bladder 100 trial were published by Thomas Powles, MD, and colleagues in The New England Journal of Medicine. Researchers reported that the PD-L1 inhibitor avelumab led to a 31% reduction in risk of death, and extended median survival by more than 7 months in patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy. Additional analyses from the trial were also presented at the ESMO Virtual Congress 2020.
Thomas Powles, MD
Further details from the subgroup analysis were presented in an on-demand mini oral session at the Congress by Grivas et al (Abstract 704MO). Additional data evaluating the association between clinical outcomes and exploratory biomarkers was presented by Sridhar et al (Abstract 699O), and patient-reported outcomes are featured in an on-demand e-poster display (Abstract 745P).
JAVELIN Bladder 100
The phase III trial evaluated the efficacy of the immunotherapeutic agent avelumab in patients with locally advanced or metastatic urothelial carcinoma whose disease had not progressed after chemotherapy. A total of 700 patients from over 200 sites around the world were assigned to two treatment groups after the completion of chemotherapy: one group receiving best supportive care alone, and the other receiving avelumab in addition to best supportive care.
Treatment with avelumab resulted in a 31% reduction in risk of death and a median overall survival of 21.4 months compared with 14.3 months in patients who did not receive the drug. The incidence of adverse events from any cause was 98.0% in the avelumab group and 77.7% in the control group, and the incidence of grade ≥ 3 adverse events was 47.4% and 25.2%, respectively. Eleven percent of patients stopped avelumab due to adverse events.
Study lead Dr. Powles, Professor of Genitourinary Oncology at Queen Mary's Barts Cancer Institute, and Director of Barts Cancer Centre, Barts Health NHS Trust, said, “This is the first time that an immune therapy clinical trial has shown a survival benefit for first-line therapy in metastatic bladder cancer. We saw a meaningful reduction in the risk of death and a significant overall survival benefit with avelumab, which underscores the potential for this immunotherapy to be practice-changing for patients. This highlights the potential benefits of a maintenance approach with avelumab in patients to prolong their lives following chemotherapy.”
The U.S. Food and Drug Administration approved avelumab in June for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results.
Disclosure: For full disclosures of the study authors, visit nejm.org.
