Expert Commentary: Avelumab, an Anti–Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study.

Platinum-resistant urothelial carcinoma is a lethal disease. After a long period of therapeutic stagnation, the last two years have witnessed an explosion in the development of new second-line therapies.

A recent study by Apolo et al. published in the Journal of Clinical Oncology examined the clinical outcomes, safety and tolerability of Avelumab, a PDL-1 inhibitor in patients. with urothelial carcinoma progressing after platinum-based chemotherapy. The multicenter trial design did not select patients based on their PD-L1 expression. Forty-four patients were treated with avelumab biweekly with a median follow up of 16.5 months. The study showed an objective response rate of 18.2% (95% CI, 8.2% to 32.7%). The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable). Avelumab was generally well-tolerated and safe. As observed with other immune checkpoint inhibitors, several responses were ongoing. The majority of responding patients had PD-L1–positive tumors. Grade 3 and 4 treatment-related adverse events occurred in only three patients. 

This crucial study provides evidence supporting the safety of Avelumab and a strong efficacy signal. Avelumab now joins a growing armamentarium of immune-checkpoint inhibitors approved in the second-line setting for patients with platinum-resistant urothelial carcinoma. Additional studies are ongoing to increase response rates and to moving these agents to earlier stages in the clinical spectrum of urothelial cancer.

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Written By: Bishoy Faltas MD

References: 
Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study.
J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.
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