Seagen and Astellas announce results from EV-302 study

Trial involves the use of Padcev and Keytruda among patients with certain types of urothelial cancer

have announced positive results from their phase 3 EV-302 clinical trial. The study involves Padcev – also known as enfortumab vedotin-ejfv – in combination with Keytruda (pembrolizumab) versus chemotherapy.

The combination therapy has been used among patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The disease is a form of bladder cancer that has spread to surrounding muscles, organs or other parts of the body.

Enrolled patients had previously untreated la/mUC who were also eligible for cisplatin or carboplatin-containing chemotherapy, irrespective of PD-L1 status.

The EV-302 trial subsequently met both its primary endpoints of overall survival (OS) and progression-free survival (PFS), compared to chemotherapy.

In addition, an independent data monitoring committee determined that OS crossed the pre-specified efficacy boundary during interim analysis.

Meanwhile, the safety results of the combination were consistent with those of enfortumab vedotin in combination with pembrolizumab, as previously reported among cisplatin-ineligible patients with la/mUC.

Roger Dansey, President, Research and Development at Seagen, explained: “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer. 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.”

Ahsan Arozullah, Senior Vice President, Head of Oncology Development at Astellas, reflected: “We are thrilled that the topline results of the EV-302 study demonstrated that the combination of enfortumab vedotin and pembrolizumab improved the dual primary endpoints of OS and PFS.”

He added: “Patients living with metastatic urothelial cancer are in dire need of additional treatment options and this combination has the potential to advance the standard of care. We are extremely grateful to all of the patients who participated in this trial.”

Bladder cancer, emerges in the urothelial cells, which line the bladder, urethra, ureters, renal pelvis and some other organs. Meanwhile, around 573,000 new cases of bladder cancer and 212,000 deaths as a result of the disease are reported every year.