Patient OS and PFS doubled. Pfizer Inc. (PFE.US) and Merck & Co., Inc. jointly announced the results of the combination therapy of Padcev and Keytruda.
12/02/2025
GMT Eight
Pfizer Inc. (PFE.US) and Astellas Pharma recently announced that they will present the long-term follow-up results of the Phase 3 clinical trial EV-302 at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in the United States. This study evaluated the effectiveness of the antibody-drug conjugate Padcev (enfortumab vedotin) in combination with Keytruda in the treatment of previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) patients. The results show that at a median follow-up time of 29.1 months, the combination therapy continued to provide benefits in overall survival (OS) and progression-free survival (PFS).
The results demonstrate that compared to chemotherapy, the combination of Padcev and Keytruda can reduce the risk of death by 49% (HR=0.51, 95% CI: 0.430.61). The median OS for the United Therapeutics Corporation group was 33.8 months, while the chemotherapy group was 15.9 months. Benefits in OS were observed in all pre-specified subgroups. Additionally, the combination regimen also reduced the risk of disease progression or death by 52% (HR=0.48, 95% CI: 0.410.57). The median PFS for the United Therapeutics Corporation group was 12.5 months, while the chemotherapy group was 6.3 months. The safety profile remains consistent with previous results, with no new safety concerns identified.