Seagen Pops on Positive Bladder Cancer Study Results

In a Phase 3 study, a cancer-drug combination involving Merck & Co. (MRK:US), Seagen (SGEN:US), and Astellas Pharma (ALPMY:US) have achieved positive results for the most common type of bladder cancer, the companies said. 

The study combined Merck's cancer drug Keytruda with Astellas' and Seagen's Padcev and compared it to chemotherapy. It successfully met its primary endpoints, demonstrating improvements in overall survival and progression-free survival among patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Locally advanced or metastatic urothelial carcinoma is a type of bladder cancer that has spread to surrounding organs, muscles, or other parts of the body.

Seagen shares rose more than 3% on the news.

"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," said Roger Dansey, M.D., President, Research and Development, Seagen.

In addition to meeting its primary endpoints of overall survival and progression-free survival, the combination of Merck's Keytruda, Astellas' Padcev, and Seagen's Padcev in the Phase 3 study also demonstrated a statistically significant improvement in overall response rate. 

This is a key secondary endpoint of the study, and it included patients who may or may not have been eligible for treatment with cisplatin-based chemotherapy, regardless of their PD-L1 status.

Merck, Seagen, and Astellas have noted that the positive results from this study are intended to serve as the basis for global regulatory submissions of the Keytruda/Padcev combination. Additionally, it will serve as the confirmatory trial for the accelerated approval granted by the U.S. Food and Drug Administration in April. 

It was reported in March that Pfizer (PFE:US) will spend $43 billion to acquire Seagen.

Congressman Josh Gottheimer was selling SGEN shares this year.