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ASCO conference: Astellas, Seattle Genetics' bladder cancer drug shrink tumors

Astellas Pharma Inc. and Seattle Genetics Inc. said enfortumab vedotin, when used alone, reduced tumor size in patients with a type of bladder cancer.

Of the 112 patients with metastatic urothelial cancer evaluated in a phase 1 study, known as EV-101, 41% showed an overall response rate, or some reduction in the cancer. Four patients had complete responses while 41 patients had partial responses.

The most commonly reported treatment-related side effects were fatigue, anemia, abnormally low sodium in the blood, urinary tract infection and high blood sugar. Four patients experienced a fatal treatment-related side effect, including respiratory failure and multi-organ failure.

For all enrolled patients, the interim median overall survival was 13.6 months, the overall median duration of response was 5.75 months and the median period at which a patient lives without the disease worsening was 5.4 months.

The EV-101 study is part of a broader program focused on investigating enfortumab vedotin in both monotherapy and in combination with a checkpoint inhibitor for locally advanced or metastatic urothelial cancer.

"Data from the ongoing study support the potential of enfortumab vedotin in locally advanced or metastatic urothelial cancer, based on the objective response rate and preliminary estimates of survival," said Jonathan Rosenberg, medical oncologist at Memorial Sloan Kettering Cancer Center and presenter of the updated phase 1 data at the 2018 American Society of Clinical Oncology meeting.

In March, the U.S. Food and Drug Administration granted breakthrough therapy designation to enfortumab vedotin.

According to the American Cancer Society, urothelial cancer, also known as transitional cell carcinoma, is the most common type of bladder cancer. About 81,000 people in the U.S. are expected to be diagnosed with bladder cancer in 2018. Bladder cancer is the fourth most common cancer in men, but is less common in women. Outcomes are poor for people diagnosed with metastatic disease, with a five-year survival rate of 4.8%.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on site and an additional 3,350 abstracts to be published online.