Efficacy

Efficacy of Bavencio (Avelumab) in Urothelial Carcinoma

Bavencio (avelumab) is a programmed death-ligand 1 (PD-L1) blocking antibody used in the treatment of urothelial carcinoma, which is a type of bladder cancer. It is specifically indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Clinical trials have demonstrated that avelumab can produce durable responses in a subset of these patients. The efficacy of avelumab in urothelial carcinoma was initially supported by the results of the JAVELIN Solid Tumor trial, a multicenter, single-arm, open-label study in patients with locally advanced or metastatic urothelial carcinoma.

In this study, the objective response rate (ORR) was a key measure of efficacy. Avelumab showed an ORR of approximately 13.3% in the overall population, with a higher response rate observed in patients with PD-L1 positive tumors. While complete responses were observed in a small percentage of patients, the median duration of response was not reached, indicating that the responses could be long-lasting. The results from this study led to the accelerated approval of avelumab in this indication by the FDA, contingent upon verification and description of clinical benefit in confirmatory trials.

Efficacy of Trodelvy (Sacituzumab Govitecan-hziy) in Urothelial Carcinoma

Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate that targets Trop-2, a protein found on many types of cancer cells, including urothelial carcinoma cells. It is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. The approval of sacituzumab govitecan-hziy for this indication was based on the results of a multicenter, single-arm clinical trial, which demonstrated significant efficacy in this patient population.

In the trial, sacituzumab govitecan-hziy achieved an ORR of 27%, with a complete response rate of 5.4%. The median duration of response was 7.2 months, indicating that the responses can be substantial for a subset of patients. The median overall survival was 12.3 months, and the median progression-free survival was 5.4 months in patients treated with sacituzumab govitecan-hziy. These results showed that sacituzumab govitecan-hziy can provide a clinically meaningful benefit to patients with advanced urothelial carcinoma who have limited treatment options.