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Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma, approved by European Commission


The European Commission ( EC ) has approved Bavencio ( Avelumab ) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma ( UC ) who are progression-free following Platinum-based chemotherapy.

In the pivotal JAVELIN Bladder 100 trial, Avelumab plus best supportive care ( BSC ) as first-line maintenance has demonstrated a significant improvement in median overall survival ( OS ) vs BSC alone at the prespecified interim analysis ( data cut-off date October 21, 2019 ): 21.4 months ( 95% CI: 18.9 to 26.1 ) versus 14.3 months ( 95% CI: 12.9 to 17.8 ) in the coprimary population of all randomized patients ( hazard ratio, HR 0.69; 95% CI: 0.56 to 0.86 ).
In the coprimary population of patients with PD-L1+ tumors ( n=358 ), overall survival was also significantly longer with Avelumab plus BSC ( median not reached; 95% CI: 20.3, not reached ) versus BSC alone ( 17.1 months; 95% CI: 13.5, 23.7; HR 0.56; 95% CI, 0.40 to 0.79 ).
Based on these data, the Avelumab first-line maintenance regimen was added to the recently updated ESMO Clinical Practice Guidelines for bladder cancer.

Updated OS results with a data cut-off of January 19, 2020 have also shown Avelumab significantly has extended overall survival among all randomized patients vs BSC alone ( HR 0.70; 95% CI, 0.56 to 0.86; two-sided P=0.0008 ), with median overall survival of 22.1 months ( 95% CI, 19.0 to 26.1 ) vs 14.6 months ( 95% CI, 12.8 to 17.8 ), respectively.

Avelumab is a human anti-programmed death ligand-1 ( PD-L1 ) antibody.
Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, Avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. ( Xagena )

Source: Pfizer & Merck KGaA, 2021

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