Bavencio Gets Accelerated Approval for Urothelial Carcinoma
Bavencio (avelumab; EMD Serono) has been granted accelerated approval by the Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease has progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The safety and efficacy of Bavencio was demonstrated in the JAVELIN Solid Tumor trial, an open-label, single-arm, multi-center study that included 242 patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Patients received Bavencio at a dose of 10mg/kg intravenously every 2 weeks until radiographic or clinical progression or unacceptable toxicity; tumor response assessments were performed every 6 weeks. Efficacy outcome measures included confirmed overall response rate (ORR) and duration of response (DOR). Efficacy was evaluated in patients who were followed for a minimum of both 13 weeks and 6 months at the time of data cut-off.
The median time to response was 2.0 months (range: 1.3 to 11.0) among patients followed for either ≥13 weeks or ≥6 months. Confirmed ORR in patients who had been followed for at least 13 weeks was 13.3% (n=30) (95% CI: 9.1, 18.4), and 16.1% (n=26) (95% CI: 10.8, 22.8) in patients who had been followed for at least 6 months. Median response duration had not been reached in patients followed for at least 13 weeks or at least 6 months, but ranged from 1.4+ to 17.4+ months in both groups.
Bavencio is a programmed death ligand-1 (PD-L1) blocking antibody. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses.
Bavencio was recently approved for the treatment of metastatic Merkel cell carcinoma.
For more information visit Bavencio.com.