Astellas Pharma (OTCPK:ALPMF) and Seattle Genetics (NASDAQ:SGEN) have announced that a Phase 3 (EV-301) trial of PADCEV (enfortumab vedotin-ejfv) met its primary endpoint of overall survival (OS) compared to chemotherapy, in adult patients with locally advanced/metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
The results were reviewed by an independent Data Monitoring Committee following a planned interim analysis.
PADCEV was approved under the FDA’s accelerated approval program for the same indication in December 2019, based on tumor response rate. The data is expected to support global registrations and convert accelerated to regular US approval.
PADCEV significantly improved OS, with a 30% reduction in risk of death (Hazard Ratio [HR]=0.70), and significant improvement in progression-free survival (PFS) was observed, with a 39% reduction in risk of disease progression or death (HR=0.61).
On the safety front, adverse events included rash, hyperglycemia, decreased neutrophil count, fatigue, anemia and decreased appetite as the most frequent severe events occurring in over 5% of patients.
Patients in the chemotherapy arm of the trial will be offered the opportunity to receive PADCEV.
PADCEV is an antibody-drug conjugate that is directed against Nectin-4.
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