Dr. Petrylak on the KEYNOTE-045 Trial for Urothelial Carcinoma

Daniel P. Petrylak, MD, professor of Medicine (Medical Oncology) and Urology, co-director, Signal Transduction Research Program, Yale Cancer Center, 2017 Giant of Cancer Care in Genitourinary Cancer, discusses the KEYNOTE-045 trial investigating pembrolizumab (Keytruda) versus physician’s choice of chemotherapy for patients with urothelial carcinoma.

KEYNOTE-045 is a randomized trial that compares pembrolizumab to a dealer's choice chemotherapy in patients with urothelial cancer that have been previously treated with platinum-based chemotherapy regimens that could be with carboplatin or cisplatin, explains Petrylak. This trial was the first to demonstrate a survival benefit in favor of the checkpoint inhibitor compared with chemotherapy.

The chemotherapy arm was about 7 months, whereas the checkpoint inhibition arm was about 10 months. That is a significant difference and is clinically meaningful. There is a proportion of patients, about 25%, who do extremely well. They have prolonged durable responses and that is what is really driving the survival benefit in the situation, states Petrylak.