Combining enfortumab vedotin and pembrolizumab improves overall survival and progression-free survival compared with standard of care among patients with untreated locally advanced or metastatic urothelial carcinoma, trial sponsors announced. The combination treatment also significantly improves overall response rate, a key secondary endpoint. Topline trial results will be formally presented at an upcoming medical meeting.
In the pivotal phase 3 EV-302 trial (also known as KEYNOTE-A39; Clinicaltrial.gov: NCT04223856), investigators randomly assigned 886 patients to receive enfortumab vedotin plus pembrolizumab or standard of care gemcitabine plus platinum-containing chemotherapy, regardless of PD-L1 status. The trial is confirmatory for the FDA accelerated approval of the combination of enfortumab vedotin and pembrolizumab as first-line treatment for patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. Enfortumab vedotin is a first-in-class antibody-drug conjugate directed against nectin-4. Pembrolizumab is an anti-programmed death receptor-1 (PD-1) therapy.
“This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Roger Dansey, MD, President, Research and Development for Seagen, a biotechnology company conducted the KEYNOTE-A39 in collaboration with Merck and Astellas, stated in a news release. “We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon as possible.”
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Disclosure: This research was supported by Astellas, Seagen, and Merck. Please see the original references for a full list of disclosures.
References
Padcev® (enfortumab vedotin-ejfv) and Keytruda® (pembrolizumab) significantly improve overall survival and progression-free survival in patients with previously untreated advanced bladder cancer in pivotal phase 3 EV-302 trial. News release. Astellas Pharma; September 22, 2023.
Merck announces phase 3 KEYNOTE-A39/EV-302 trial met dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in certain patients with previously untreated locally advanced or metastatic urothelial cancer. News release. Merck; September 22, 2023.
FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma. News release. FDA; May 3, 2023.