The Food and Drug Administration (FDA) has approved Bavencio® (avelumab; EMD Serono) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

The approval was based on data from the multicenter, open-label, parallel-arm phase 3 JAVELIN Bladder 100 study that assessed the efficacy of avelumab plus best supportive care (BSC) as first-line maintenance treatment in 700 adult patients with locally advanced or metastatic urothelial carcinoma that did not progress with first-line platinum-containing chemotherapy. 

Patients were randomized 1:1 to receive either avelumab intravenous infusion every 2 weeks plus BSC or BSC alone. The primary end point was overall survival (OS) in all randomized patients and patients with PD-L1-positive tumors.

Results showed that OS in the overall population treated with avelumab plus BSC was 21.4 months (95% CI, 18.9-26.1) compared with 14.3 months (95% CI, 12.9-17.9) for BSC alone (hazard ratio [HR] 0.69; 95% CI, 0.56-0.86; P =.001). Additionally, among PD-L1-positive patients treated with avelumab (n=358), the risk of death was reduced by 44% compared with BSC alone (HR 0.56; 95% CI, 0.40-0.79; P <.001). Moreover, the OS hazard ratio was 0.85 (95% CI, 0.62-1.18) in an exploratory analysis of PD-L1-negative patients (n=271). 

As for safety, the most commonly reported adverse reactions included fatigue, musculoskeletal pain, urinary tract infection, and rash. Serious adverse reactions occurred in 28% of avelumab-treated patients; 1 patient died from sepsis.

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Bavencio, a programmed death-ligand 1 (PD-L1) blocking antibody, is already indicated for the treatment of locally advanced or metastatic UC in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. It is also approved in combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC), and for the treatment of metastatic Merkel cell carcinoma (MCC).

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