Merck, Seagen, Astellas Phase 3 Bladder Cancer Study Hits Endpoints

By Colin Kellaher

A Phase 3 study of a cancer-drug combination from Merck & Co., Seagen and Astellas Pharma has met its key goals in certain patents with he most common type of bladder cancer.

The companies on Friday said the study that combined Merck's blockbuster cancer drug Keytruda with Astellas' and Seagen's Padcev versus chemotherapy met its dual primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

The companies said the combination also showed a statistically significant improvement in overall response rate, a key secondary endpoint of the study, which enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, regardless of PD-L1 status.

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

Merck, Seagen and Astellas said the study is intended to serve as the basis for global submissions of the Keytruda/Padcev combination and as the confirmatory trial for the accelerated approval the U.S. Food and Drug Administration granted to the combination in April.

The companies, which formed a collaboration in late 2019 to study Padcev in combination with Keytruda in urothelial cancer, said they are evaluating the pairing as part of an extensive clinical development program in multiple stages of the disease.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 22, 2023 06:47 ET (10:47 GMT)

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