Padcev in combination with Keytruda has been granted Breakthrough Therapy status by the FDA for the treatment of patients in first-line advanced bladder cancer.
The designation was granted based on results from the dose-escalation cohort and expansion cohort A of the phase 1b/2 trial EV-103, evaluating patients with locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy treated in the first-line setting with Padcev (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda (pembrolizumab).
EV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of Padcev alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.
“This is an important step in our investigation of Padcev in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy,” said Roger Dansey, Chief Medical Officer of Seattle Genetics.
“Based on encouraging early clinical activity, we recently initiated a phase 3 trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.”
Andrew Krivoshik, Senior Vice President and Oncology Therapeutic Area Head at Astellas, added: “The FDA’s Breakthrough Therapy designation reflects the encouraging preliminary evidence for the combination of Padcev and pembrolizumab in previously untreated advanced urothelial cancer to benefit patients who are in need of effective treatment options.”