ALPMF - Seagen/Astellas's Pacdev shows durable response in mid-stage urothelial cancer study

Seagen (SGEN) and its collaborating partner Astellas Pharma (ALPMF) have announced topline results from the second cohort of Phase 2 EV-201 trial, evaluating its antibody-drug conjugate Pacdev (enfortumab vedotin-ejfv) for patients with locally advanced/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 demonstrated 52% objective response rate per blinded independent central review, and a median duration of response of 10.9 months.On the safety front, treatment-related adverse events that were severe or higher occurred in more than 5% of patients were: neutropenia, rash, fatigue, increased lipase, diarrhea, decreased appetite, anemia and hyperglycemia.PADCEV is an antibody-drug conjugate that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.The 128-subject trial's primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control

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Seagen/Astellas's Pacdev shows durable response in mid-stage urothelial cancer study