Exploring The Use of Enfortumab Vedotin in Rare Genitourinary Cancers


Attending educational sessions may help with understanding how to manage toxicities associated with enfortumab vedotin in rare genitourinary cancers.

Marijo Bilusic, MD, PhD spoke with CancerNetwork® at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting about the planned investigation of enfortumab vedotin-ejfv (Padcev) with or without pembrolizumab (Keytruda) in less common genitourinary (GU) malignancies as part of the phase 2 E-VIRTUE trial (NCT06041503).1

Bilusic, a professor of Clinical Medicine and the Genitourinary Site Disease Group Leader at Sylvester Comprehensive Cancer Center of the University of Miami Health System, highlighted how this trial in progress aims to evaluate enfortumab vedotin-based treatment in patients who have no other standard therapy options available. If investigators observe a signal among this pretreated study population, Bilusic suggested that future work may involve incorporating the agent into earlier lines of treatment.

Based on prior reports, common toxicities associated with enfortumab vedotin may include rash, neuropathy, and blood glucose increases. According to Bilusic, becoming more comfortable with mitigating these adverse effects in this population is a matter of acquiring more experience with using the drug. Additionally, attending educational sessions may help clinicians understand the agent’s safety profile.

In the multi-center E-VIRTUE trial, investigators will evaluate treatment among patients 18 years and older with histologically confirmed advanced or metastatic pure adenocarcinoma of the urinary tract, pure squamous cell carcinoma of the urinary tract, or treatment-refractory testicular germ cell tumors.2


We are now targeting patients who have run out of standard options. The goal is to eventually move [enfortumab vedotin] earlier in the disease course so people [may receive it as] frontline therapy. If there’s a signal we see in the patients who are heavily pretreated, hopefully, we can move it earlier [and use it as] frontline therapy for those patients.

Based on the current information we have from the package insert [for enfortumab vedotin], we know there is some neuropathy. One of the main [adverse] effects was rash plus elevated blood glucose. Getting familiar with the package insert, managing drugs, and attending educational sessions can help us better manage these patients. It’s [about getting] experienced as we go. The same thing [happened] with immune checkpoint inhibitors. Ten years ago, [clinicians] didn’t have much experience. As we start using the drug more and more, reading about it, and attending educational sessions, I think we became more comfortable managing those [adverse] effects.


  1. Chandran E, Simon NI, da Motta Girardi D, et al. A phase II multicenter study of enfortumab vedotin with or without pembrolizumab in rare genitourinary tumors (E-VIRTUE). J Clin Oncol. 2024;42(suppl 16):TPS4628. doi:10.1200/JCO.2024.42.16_suppl.TPS4628
  2. Enfortumab vedotin with or without pembrolizumab in rare genitourinary tumors (E-VIRTUE). ClinicalTrials.gov. Accessed May 31, 2024. https://tinyurl.com/5cdjyb5a
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