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The FDA expanded the approval of avelumab (Bavencio) on Tuesday, to include first-line maintenance in locally advanced or metastatic bladder cancer patients, drugmakers .

Approval of the PD-L1-directed checkpoint inhibitor was based on findings from JAVELIN Bladder 100, a phase III trial that randomized 700 patients with at least stable disease following first-line platinum-based chemotherapy (gemcitabine plus either cisplatin or carboplatin) to best supportive care with or without maintenance avelumab.

From the time of randomization, overall survival (OS) improved from 14.3 months to 21.4 months with the addition of avelumab (HR 0.69, 95% CI 0.56-0.86, P=0.001).

"As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years," said investigator Petros Grivas, MD, PhD, of the University of Washington in Seattle.

"The JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease," Grivas added.

Patients with high levels of PD-L1 expression saw a further OS benefit with maintenance avelumab (HR 0.56, 95% CI 0.40-0.79, P<0.001), though the benefit in low PD-L1 expressors in an exploratory analysis was less clear (HR 0.85, 95% CI 0.62-1.18).

Common adverse events (AEs) among patients who received avelumab (≥20%) included fatigue, musculoskeletal pain, rash, and urinary tract infections (UTIs). More than a quarter (28%) experienced serious AEs, the most common of which were UTIs in 6.1%, pain in 3.2%, acute renal injury in 1.7%, hematuria in 1.5%, and infusion-related reactions and sepsis in 1.2% each. One patient in the maintenance arm died from sepsis.

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