Preliminary durability results of the EV-103 study show that the combination of enfortumab vedotin and pembrolizumab may be a promising option for patients with locally advanced or metastatic urothelial carcinoma.
There has been a boom in bladder cancer advances in recent years, and the developments are not stopping yet. In fact, preliminary durability results of the EV-103 study show that the combination of enfortumab vedotin (EV) and pembrolizumab (Keytruda) may be a promising option for patients with locally advanced or metastatic urothelial carcinoma.
“This is a very promising set of data in this needy patient population. However, it’s also only a 45-patient trial,” said Jonathan E. Rosenberg, MD, chief of genitourinary oncology at Memorial Sloan Cancer Center.
In the phase Ib/II trial, there was a 73% response rate, with just over 15% of patients having complete responses, Rosenberg said, elaborating that responses were not dependent on PD-L1 status.
Additionally, average progression-free survival (PFS) was 12.3 months, which is longer than typical for this patient population—between 9 and 12 months, according to Rosenberg. Median overall survival had not yet been reached.
“The 1-year survival landmark analysis at this time point shows that 86% of patients are still alive at 1 year, which is a very impressive statistic in the context of the disease,” Rosenberg said. “The median duration of response has not yet been reached after a median follow-up of at least 10 months.”
But, like all cancer regimens, there are adverse events (AEs) that oncology nurses should look out for.
“There’s no free lunch in cancer medicine,” Rosenberg said. “There are toxicities that are associated with EV/pembrolizumab. [The combination] was notable for really the similar toxicity profile that you see with each drug alone.”
Rash was a common AE, that was typically managed with topical steroids, Rosenberg said. Peripheral neuropathy and immune-related adverse events also occurred in some patients and were treated with steroids.
“Most of the toxicities were low-grade and manageable with either treatment interruption or decreasing the doses of enfortumab. The overall tolerability I think was quite good. We didn't see any surprising new safety signals,” Rosenberg said. “We did note that there are about 20% of patients who have elevated lipase levels without any evidence of pancreatitis, so no clinical signs of symptoms. Those patients continued on treatment and were monitored.”
Rosenberg also said that he is eager to see the results of the larger expansion cohort looking at the combination. The randomized phase III trial is about to start enrollment. He also mentioned that this overall is a very exciting time for the treatment of bladder cancer.
“There's a lot of exciting work going on in non-muscle invasive disease that I think will change how we treat those patients and give them many more options,” Rosenberg said.