Seattle Genetics and Astellas Pharma have completed the enrolment of the first cohort of patients in the EV-201 trial, a pivotal Phase ll clinical trial of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer.
The cohort includes around 120 patients who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1) at various sites.
The second cohort of the EV-201 trial is currently enrolling cisplatin-ineligible, platinum naïve patients with urothelial cancer who have received a PD-1/PD-L1 inhibitor but not a platinum agent.
The primary objective of the ongoing single-arm, single-agent trial is confirmed objective response rate, measured by independent review.
The trial’s secondary objectives are assessments of response duration, disease control, overall survival, progression-free survival, safety and tolerability.
Topline efficacy and safety results from the first cohort of the EV-201 trial are scheduled to be available in the first half of next year.
Astellas Pharma Oncology Development senior vice-president and Global Therapeutic Area head Steven Benner said: “Despite recent treatment advances, the unfortunate reality is that many patients with metastatic urothelial cancer currently find that their disease will progress after anti-PD-1 or PD-L1 therapy, highlighting the need to identify additional therapeutic options.
“Following encouraging results from our ongoing Phase l study, we and our partners at Seattle Genetics decided to proceed with these registrational trials.”
In addition, Seattle Genetics and Astellas have dosed the first patient in their EV-301 trial, which is a Phase lll study designed to investigate enfortumab vedotin against chemotherapy in patients with previously treated locally advanced or metastatic urothelial cancer.
The global, open-label, randomised EV-301 trial aims to enrol around 550 patients who were previously treated with a PD-1/PD-L1 inhibitor and platinum-based therapies.