Dr. Petrylak on the Rationale of the EV-103 Trial in MIBC

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Daniel P. Petrylak, MD, professor of medicine and urology, coleader, Cancer Signaling Networks, Yale Cancer Center, discusses the rationale for of the phase 1b/2 EV-103 trial (NCT03288545) in patients with muscle-invasive bladder cancer (MIBC).

The EV-103 trial focused on patients with MIBC who were not eligible to receive cisplatin neoadjuvant chemotherapy, Petrylak says. Cisplatin-based chemotherapy is the current standard of care for those eligible in the patient population, and approximately one-third of those patients will achieve a pathological complete response, Petrylak adds. Cisplatin has been demonstrated to improve survival when compared with cystectomy alone in those with locally advanced muscle invasive disease, Petrylak explains.

The EV-103 study identified cisplatin-ineligible patients who predominately presented with poor renal function, Petrylak notes. They were administered enfortumab vedotin-ejfv (Padcev) for 3 cycles. Moreover, the cycles were adjusted so patients received the therapy on days 1 and 8, rather than days 1, 8, and 15, which is approved the approved regimen for metastatic patients, Petrylak concludes.