An immunotherapy drug significantly improves survival in some bladder cancer patients, according to results of a global phase III clinical trial.
The findings of the study, led by Professor Tom Powles from Queen Mary University of London and Barts Cancer Centre, UK, found that avelumab led to a 31% reduction in risk of death of bladder cancer and extended median survival in advanced bladder cancer by more than seven months.
It could potentially benefit thousands of patients each year, say the authors, who are to present their results in the plenary session at the American Society of Clinical Oncology.
JAVELIN Bladder 100, the global phase III trial, focused on patients whose cancer was advanced or at stage 4 and evaluated the efficacy of avelumab in patients with locally advanced or metastatic urothelial carcinoma, which they received after the initial chemotherapy.
The participating cohort comprised 700 patients from more than 200 sites around the world and they were assigned to two treatment groups after their chemotherapy was completed – one received standard care on its own, while the other received avelumab in addition to standard care.
Treatment with avelumab resulted in a 31% reduction in risk of death and the median overall survival of 21.4 months compared with 14.3 months in patients who did not receive the drug. Side effects were in line with expectations with immune therapy and 11% of patients stopped avelumab due to treatment problems.
Professor Thomas Powles 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.”
Powles T, Hoon Park S, Voog E et al. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. American Society of Clinical Oncology ASCO20 conference Plenary Session.
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