Dr. Bilusic on the E-VIRTUE trial in rare genitourinary cancers

In this video, Marijo Bilusic, MD, PhD, discusses the background and design of the E-VIRTUE trial, which was highlighted at the 2024 American Society for Clinical Oncology Annual Meeting in Chicago, Illinois with the abstract, “A phase II multicenter study of enfortumab vedotin with or without pembrolizumab in rare genitourinary tumors (E-VIRTUE).” Bilusic is a medical oncologist at the University of Miami Sylvester Comprehensive Cancer Center in Florida.

Video Transcript:

Could you describe the rationale for the E-VIRTUE study?

There's a pretty strong rationale. The population we are targeting are patients with rare histologies [for which] there is no standard therapies available. The analyses [and] preclinical work done by Dr. Apolo and her team identified that nectin is overexpressed in majority of patients with adenocarcinoma of the bladder, squamous cell of the bladder, and testicular cancer. There are no standard therapies available for those patients. There is a hypothesis that nectin-4 as a potential target for antibody drug conjugates, such as EV, potentially should work.
How is the trial designed?

The trial is targeting patients with rare histologies, those 3 main categories of patients, and some of them may have prior checkpoint inhibitors. Patients are going to be divided into cohorts. One cohort is going to be a checkpoint naive cohort, for those patients who have never had prior immune checkpoint inhibitors. These patients will receive combination therapy, EV plus pembro on a standard schedule, which is FDA approved for urothelial cancer. There is a second cohort, which is patients who already progressed on checkpoint inhibitors. These patients will receive EV only, also on the schedule of week 1, 2, 3 with 1 week off in a 28-day cycle. This is an approved indication. The duration of treatment is up to 5 years for EV and up to 2 years for pembrolizumab. It's a standard thing. Patients who are having complete responses may stop pembrolizumab and then restart if they progress in the future.

This transcription has been edited for clarity.