Safety Profile of Enfortumab Vedotin in Urothelial Cancers

Thomas Powles, MD, MBBS, MRCP, a professor of genitourinary oncology, director of the Bart Cancer Centre, and lead for Solid Tumour Research at Cancer Research UK, discusses the safety profile of enfortumab vedotin (Padcev) in urothelial cancers as observed in the phase 3 EV-301 trial (NCT03474107).

According to Powles, the toxicity was found to be manageable, with a rate of grade 3/4 adverse events being approximately 50%. However, compared with the standard chemotherapy, different events were seen. For example, investigators in the experimental arm looked at neuropathy, skin toxicity and hyperglycemia.

Some patients required dose reductions or delays due to toxicities. However, safety has been consistent and high efficacy signaling has been observed.

0:08 | The toxicity profile is manageable. In fact, the adverse event profile showed that the percentage of grade 3 or 4 adverse events were about 50% in both groups. However, the antibody-drug conjugate had different adverse event profiles to standard chemotherapy. We looked out for neuropathy, skin toxicity, and hyperglycemia, particularly, which require attention. And we need to look at those while we're treating our patients. Some patients, indeed, recall, dose reductions or dose delays because of that. But overall, when you look at this, you say this is a new class of drug opening a new chapter in urothelial cancer, when you look at the previous trials and other studies and looking at enfotrumab vedotin in different settings. We're showing a drug with a very consistent [safety profile] with a high efficacy signal. I think this is going to be a big change for patients with bladder cancer over the next 10 years.