Astellas Pharma - Seagen's Enfortumab Shows 36% Pathologic Complete Response In Bladder Cancer Patients

Seagen Inc SGEN and Astellas Pharma Inc ALPMF announced the initial results from Cohort H of the EV-103 trial investigating PADCEV (enfortumab vedotin-ejfv) in muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. 

• Data will be presented at the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU).
• The preliminary analysis of 22 patients showed 36.4% had a pathologic complete response, the primary endpoint, displaying no signs of cancer upon microscopic examination of tissue cells removed during surgery. 
• Also See: Seagen's SEA-CD40 Combo Regime Shows Preliminary Antitumor Activity In Pancreatic Cancer.
• Half (50%) of all patients had a pathological downstaging, or reduction in tumor size, a secondary endpoint of the trial. 
• All patients underwent surgery, and no surgeries were delayed following treatment with enfortumab vedotin. 
• "The initial findings from EV-103 Cohort H are encouraging, and we look forward to learning more from the Phase 3 studies evaluating enfortumab vedotin in muscle-invasive bladder cancer in combination with the anti-PD-1 therapy pembrolizumab," said Marjorie Green, SVP and Head of Late-Stage Development, Seagen.
• Price Action: SGEN shares closed at $124.51 on Monday.