RTTNews | Oct 12, 2020 07:56AM EDT

07:55 Monday, October 12, 2020 (RTTNews.com) - Astellas Pharma Inc. (ALPMY, ALPMY) and Seagen Inc. (SGEN) announced results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial saying that durable responses were observed in patients who had previously received immunotherapy but were ineligible for cisplatin in locally advanced or metastatic setting.

The phase 2 single-arm clinical trial, known as EV-201, results showed a 52 percent objective response rate per blinded independent central review and a median duration of response of 10.9 months.

The most frequently reported treatment-related adverse events Grade 3 or greater that occurred in more than 5 percent of patients were: neutropenia, rash, fatigue, increased lipase, diarrhea, decreased appetite, anemia and hyperglycemia.

The cohort is evaluating the antibody-drug conjugate PADCEV or enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and have not received a platinum-containing chemotherapy and are ineligible for cisplatin.

PADCEV is a antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.

The U.S. Food and Drug Administration granted accelerated approval to PADCEV in 2019 based on results from the first cohort in this trial.

Urothelial cancer is the most common type of bladder cancer, and can also be found in the urothelial cells that line the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.

Read the original article on RTTNews ( https://www.rttnews.com/3135459/astellas-seagen-s-pacdev-shows-durable-response-in-phase-2-urothelial-cancer-study.aspx)

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