Dr. Rosenberg on the KEYNOTE-045 Trial in Advanced Urothelial Cancer

Jonathan E. Rosenberg, MD, medical oncologist, chief, Genitourinary Medical Oncology Service, Memorial Sloan Kettering Cancer Center, discusses the phase 3 KEYNOTE-045 trial in advanced urothelial cancer.

KEYNOTE-045 randomized patients with advanced urothelial cancer who had progressed or recurred on platinum-based chemotherapy to pembrolizumab (Keytruda) or investigator’s choice of paclitaxel, docetaxel, or vinflunine.

Results showed that patients who received pembrolizumab had prolonged overall survival compared with those who received chemotherapy. Moreover, long-term follow-up results revealed that 20.7% of patients who responded to pembrolizumab experienced durable responses lasting 3 years, says Rosenberg.

Advanced urothelial cancer is associated with a 5% to 10% survival rate, says Rosenberg. Using a single-agent checkpoint inhibitor in the second-line setting could improve survival for these patients.

KEYNOTE-045 revealed that patients with a PD-L1 combined positive score (CPS) of 10% or greater did not derive a significant improvement in outcomes compared with the total population, says Rosenberg. As such, PD-L1 testing is not done for patients who progress on prior platinum chemotherapy.