Dr. Galsky on the HCRN GU14-182 Study Results in Urothelial Cancer

Matthew Galsky, MD, director, Genitourinary Medical Oncology, The Tisch Cancer Institute, Mount Sinai Hospital, discusses results from the HCRN GU14-182 study, which examined maintenance pembrolizumab (Keytruda) versus placebo in patients with metastatic urothelial cancer.

Response rate was a secondary endpoint of the study. In a maintenance study, patients can enter the study having had a complete response (CR) to first-line chemotherapy, Galsky explains. There are differing opinions regarding whether those patients should receive a switch maintenance treatment approach. One side of the argument is that a switch maintenance approach could lead to a real durable complete response in this group of patients, according to Galsky.

However, if chemotherapy has done a really good job, the other argument is those patients should be offered a treatment-free interval. The numbers will be small, but ultimately, physicians will be able to look at the subset of patients who had a CR going into the study and were randomized to pembrolizumab versus placebo, says Galsky. Although, researchers need to be aware because patients who are in a CR when entering the study need to be taken out of the objective response analysis; this is because there's nothing to measure in terms of the response assessment, Galsky explains.