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Thomas Flaig, MD


ESMO 2022: Enfortumab Vedotin Plus Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer

By: Victoria Kuhr, BA
Posted: Thursday, September 22, 2022

Enfortumab vedotin-ejfv plus pembrolizumab (EV+P) treatment demonstrated a high objective response rate with rapid responses in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer, based on the results Study EV-103 Cohort K. Additionally, Jonathan E. Rosenberg, MD, of Memorial Sloan-Kettering Cancer Center, New York, and colleagues reported that the safety profile for enfortumab vedotin monotherapy and EV+P was tolerable and generally consistent with prior experience. These findings were presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA73).

Patients with locally advanced or urothelial cancer who were ineligible for treatment with cisplatin were included in the analysis. These patients were randomly treated with 1.25 mg/kg of enfortumab vedotin on days 1 and 8 or Ev+P on day 1 of a 3-week cycle. The data cutoff for the study was June 2022.

Of the 149 patients included in this cohort, 76 were treated with EV+P and 73 were treated with enfortumab vedotin alone. The objective response rate for the combination therapy was 64.5%, and the median duration of response was not reached. The median follow-up for the combination treatment was 14.8 months, and for monotherapy, it was 15 months. The objective response rate for enfortumab vedotin treatment alone was 45.2%, and the median duration of response was 13.2 months. EV+P yielded a 53.9% partial response rate and a 10.5% complete response rate. Additionally, 7.9% of patients experienced disease progression, and 22.4% experienced disease stability. Enfortumab vedotin monotherapy resulted in a 41.1% partial response rate and a 4.1% complete response. Additionally, 9.6% of patients experienced disease progression, and 34.2% experienced disease stability.

Most treatment-related adverse events were ≤ grade 2. The treatment-related adverse events of interest included skin reactions, peripheral neuropathy, ocular disorders, and hyperglycemia.  

Disclosure: For full disclosures of the study authors, visit

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