The following is the summary of “First-line avelumab for patients with PD-L1-positive metastatic or locally advanced urothelial cancer who are unfit for cisplatin” published in the November 2022 issue of Oncology by Lacovelli, et al.

Metastatic urothelial carcinoma (mUC) is typically treated with cisplatin-based chemotherapy. But around half of patients are deemed ineligible for cisplatin treatment. However, anti-PD-1/anti-PD-L1 medicines have broadened clinicians’ toolkits, making them better able to treat these individuals. Therefore, the purpose of this research was to assess the efficacy and safety of avelumab as a primary treatment for mUC. Central PD-L1 expression screening was performed, and only patients with mUC who scored 5% or less on the tumour proportion score were included in the trial. 

One-year overall survival (OS) was the primary goal, while the secondary endpoints were median OS, median progression-free survival, overall response rate, duration of response, safety, and tolerability. The Kaplan-Meier product-limit method was used to estimate survival times, and the log-rank test was used to compare survival times between groups. From a pool of 198 potential participants, 71 (34.9%) with PD-L1 expression at or below ≥5% were included in the study. Among those diagnosed, the median age was 75, 73.2% had bladder cancer as their main tumor, and 25.3% had liver metastases. 70.4% of patients had a creatinine clearance of less than 60 milliliters per minute, and 31 % had a performance status of 2, according to the Eastern Cooperative Oncology Group. Of those who made it to a year and beyond, 43% were still with us. 

The median OS was 10.0 months (95% CI 5.5-14.5 months). In 8.5% of cases, there was a complete response, while in 15.5%, there was just a partial response. Nearly half (49.3%) of patients experienced some form of an adverse event, and nearly 10% experienced an event of severe severity. There was only one serious side effect caused by the treatment, and it was an infusion reaction of severity level 3. It was reported that there were no fatalities associated with the treatment. The efficacy and safety of avelumab in treating mUC was proven in the ARIES study, expanding the arsenal of authorized checkpoint inhibitors for platinum-ineligible, locally advanced/mUC.