Human Urinary System Kidneys with Bladder Anatomy


Astellas Pharma (OTCPK:ALPMY) (OTCPK:ALPMF) and Seagen (NASDAQ:SGEN) said Cohort K of a phase 1b/2 trial of their drug Padcev in combination with Merck’s (NYSE:MRK) Keytruda showed response in certain patients with a type of bladder cancer.

In the group K of the study — dubbed EV-103, also known as KEYNOTE-869 — patients treated with Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) showed a 64.5% confirmed objective response, which was main goal of cohort K, the companies said in a July 26 press release.

The companies added that the median duration of response (DOR) was not reached.

The most frequently reported treatment-emergent adverse events (TEAEs) Grade 3 or greater that occurred in more than 5% of patients were rash maculo-papular, anemia, lipase increased, urinary tract infection, high blood glucose, fatigue, low count of type of white blood called neutropenia , blood in urine, diarrhea, acute kidney injury, lower sodium levels and chronic kidney disease.

Other TEAEs were fainting, weight decrease, low levels of phosphorous, pneumonitis, sepsis, and increase in alanine aminotransferase (ALT)— an enzyme found in liver, high levels of ALT may suggest liver damage.

The cohort K was evaluating Padcev alone or in combination with Keytruda as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy.

Urothelial cancer begins in cells called urothelial cells which line urethra, bladder, ureters, renal pelvis, and certain other organs.

“We intend to discuss Cohort K results with regulatory authorities as we seek to develop a new first-line treatment combination for these patients,” said Ahsan Arozullah, senior vice president and head of Development Therapeutic Areas, Astellas.

The three companies are evaluating the drug combo as part of a collaboration, which also includes three phase 3 studies: the EV-302/KEYNOTE-A39 trial intended to confirm these results, and EV-304/KEYNOTE-B15 and EV-303/KEYNOTE-905 in muscle-invasive bladder cancer.

SGEN +3.27% to $178.50 premarket July 26

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