medwireNews: The JAVELIN Bladder 100 trial has shown a significant improvement in the overall survival (OS) of advanced urothelial cancer patients with the addition of avelumab to best supportive care (BSC) in the maintenance setting.
Presenting the findings at the virtual 2020 ASCO Annual Meeting, Thomas Powles (Barts Cancer Institute, London, UK) noted that avelumab was also associated with a significant progression-free survival (PFS) benefit and the toxicity was “manageable and consistent with previous studies of avelumab monotherapy.”
Thomas Powles discusses the JAVELIN Bladder 100 trial findings, and puts them into context with other studies in this setting (6:19).
Maintenance treatment with the PD-L1 inhibitor should therefore be considered “a new standard of care” for patients with locally advanced or metastatic urothelial cancer whose disease has not progressed after first-line platinum-based therapy, he commented.
The trial participants, all of whom had at least stable disease after four to six cycles of gemcitabine plus cisplatin or carboplatin, were randomly assigned to receive maintenance avelumab 10 mg/kg every 2 weeks with BSC (n=350) or just BSC (n=350), with median follow-up periods of 19.6 and 19.2 months, respectively.
The addition of avelumab to BSC was associated with a significant 31% reduction in the risk for death, with median OS durations of 21.4 and 14.3 months for the avelumab and BSC alone groups, respectively. The corresponding OS rates were 71% versus 58% at 12 months and 61% versus 44% at 18 months.
The findings were similar in the 51% of patients who were PD-L1-positive as assessed by the SP263 test, with a reduction in the risk for death of 44% favoring avelumab. The median OS times were unreached and 17.1 months for the avelumab and control arms, respectively.
Avelumab addition also led to a significant improvement in PFS relative to BSC alone in the overall population and the PD-L1-positive group, at a hazard ratio for progression or death of 0.62 and 0.56, respectively. The median PFS durations in the total study population were a respective 3.7 and 2.0 months for avelumab-treated patients and those who received BSC alone.
Powles highlighted that avelumab was well tolerated, which he said was “very much in line with what we’ve seen for previous immune checkpoint inhibitors in urothelial cancer.”
Adverse events of at least grade 3 occurred in 47.4% of patients in the avelumab group and 25.2% of those in the BSC alone group, with urinary tract infection (4.4 vs 2.6%), anemia (3.8 vs 2.9%), hematuria (1.7 vs 1.4%), fatigue (1.7 vs 0.6%), and back pain (1.2 vs 2.3%) the most common events of this severity.
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