Bavencio

Bavencio (avelumab) is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. It received accelerated approval for metastatic Merkel Cell Carcinoma (MCC) in March 2017 and approval for aRCC in combination with axitinib in May 2019. The recommended dosage for both Merkel Cell Carcinoma and Urothelial Carcinoma is 800 mg.

In clinical trials, Bavencio demonstrated a median overall survival of 21.4 months, compared to 14.3 months in a comparator arm, representing a 31% reduction in the risk of death (hazard ratio 0.69, p-value <0.0005). For PD-L1-positive tumors, the reduction in risk of death was 44% compared to a BSC arm with a median overall survival of 17.1 months. In first-line metastatic MCC, the confirmed objective response rate (ORR) was 62%, with 83% of patients achieving at least 6 months durability of response. For second-line treatment, the objective response rate was 33%.

Safety findings indicate that 14.2% of patients experienced immune-related adverse events (all categories and grades), with 2.2% experiencing Grade >= 3 immune-related adverse events. Pneumonitis incidence was 1.2%, with fatal pneumonitis occurring in 0.1% of patients. The median time to onset of immune-mediated pneumonitis was 2.5 months.