PROs Support First-Line Use of Enfortumab Vedotin+Pembrolizumab for Advanced UC – Renal and Urology News

Patient-reported outcomes (PROs) among patients with advanced urothelial carcinoma (UC) show that treatment with enfortumab vedotin with or without pembrolizumab is associated with preserved or improved quality of life (QOL), according to a recent study.

The finding is from a phase 1b/2 trial (ClinicalTrials.gov Identifier: NCT03288545) in which investigators evaluated the impact of first-line enfortumab vedotin (EV) alone or with pembrolizumab on patient QOL, emotional functioning, and symptoms in cisplatin-ineligible patients with locally advanced or metastatic UC. They randomly assigned patients 1:1 to receive enfortumab monotherapy intravenously (1.25 mg/kg once daily) on days 1 and 8 or enfortumab plus pembrolizumab intravenously (200 mg once daily) on day 1 of 3-week cycles. A total of 149 patients received treatment: 73 in the monotherapy arm and 76 in the combination arm.

“Patient-reported outcomes demonstrated preservation or improvement in quality of life. In particular, pain improvement was seen with both the combination and EV monotherapy,” said lead investigator Matthew I. Milowsky, MD, of the University of North Carolina at Chapel Hill.

Worst pain, average pain, pain interference, and pain severity remained stable over time, with small-to-moderate improvements observed at weeks 8, 12, and 24 compared with baseline.

In the combination and monotherapy arms, 76.7% and 65.4% of patients experienced a sustained improvement in pain, respectively, with a median time to improvement of 1.2 and 1.0 months, respectively. In the combination and monotherapy arms, 73.9% and 47.7% of patients experienced an improvement in worst pain, respectively, with a median time to improvement of 1.1 months and 1.4 months, respectively.

Gary D. Steinberg, MD, professor of urology at RUSH University in Chicago, Illinois, said this QOL study is important for physicians treating patients with advanced bladder cancer because it provides reassurance that patients find EV plus pembrolizumab tolerable and acceptable. “This new combination of enfortumab vedotin plus pembrolizumab has significantly changed the disease-free and cancer-specific survival rates for patients with locally advanced and metastatic bladder cancer,” Dr. Steinberg said. “In both the cisplatin eligible and ineligible population, the increase in survival is truly remarkable and completely changes the treatment paradigm for this traditionally difficult-to-treat population.”