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Astellas (ALPMY) and Seagen (SGEN) Announce Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer

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SGEN

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ALPMY

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Additional Information

Clinical Data The cohort is evaluating the antibody-drug conjugate PADCEV® (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. Results showed a 52 percent objective response rate (ORR) [95% Confidence Interval (CI): 40.8, 62.4] 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. Data from cohort 2 of the trial will be submitted for presentation at an upcoming scientific congress and will be discussed with regulatory authorities.
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Catalyst Date
Occurred on:
Oct 12, 2020
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Related Keywords Padcev, Enfortumab Vedotin-ejfv, Advanced Urothelial Cancer