Dr. Plimack on KEYNOTE-045 Trial for Pembrolizumab in Urothelial Carcinoma

Elizabeth Plimack, MD, director of Genitourinary Clinical Research at Fox Chase Cancer Center, discusses the updated findings of the KEYNOTE-045 trial of pembrolizumab (Keytruda) in urothelial carcinoma.

This is the randomized phase III trial of pembrolizumab versus chemotherapy in metastatic urothelial carcinoma, Plimack explains. This is the only data of a randomized trial in this field, which was also positive. These findings were the basis of the May 2017 FDA approval of pembrolizumab for this patient population.

Updated findings showed that the overall survival benefit with pembrolizumab is maintained with more follow-up. Additionally, all patients on the chemotherapy arm have come off of treatment, while 33 patients on the pembrolizumab arm have maintained treatment. Indeed, the progression-free survival in the chemotherapy arm is higher but the responses are not durable, which is the opposite of what is expected with the pembrolizumab data, she adds.