Seagen and Astellas' combination therapy has landed a key trial win in patients with previously untreated metastatic bladder cancer.
The partners shared positive topline results from the phase 3 EV-302 clinical trial for their antibody-drug conjugate, Padcev, and Merck's PD-1 inhibitor blockbuster, Keytruda versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles.
The EV-302 study met its dual primary endpoints of overall survival and progression-free survival, compared to chemotherapy.
Padcev on its own was granted accelerated approval by the FDA in 2019, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/L1 inhibitor and platinum-containing chemotherapy, and granted full approval in 2021. The combination Padcev-Keytruda treatment received accelerated approval from the FDA back in April, offering a first in line alternative for patients who are not eligible to receive cisplatin-containing chemotherapy.
However the EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status — opening the door to a wider patient population.
“This study has the potential to be practice-changing and offer a new standard of care for first-line metastatic bladder cancer," said Roger Dansey, Seagen's president of R&D.