Pfizer and Astellas PADCEV plus Keytruda Cuts Bladder Cancer Recurrence Risk 47%
On February 27, Pfizer and Astellas reported perioperative PADCEV plus pembrolizumab cut risk of tumor recurrence, progression or death by 47% versus neoadjuvant gemcitabine-cisplatin, with 79.4% event-free at two years versus 66.2%. Overall survival improved with a 35% reduction in death risk and pathological complete response reached 55.8% versus 32.5%.
1. Positive Phase 3 EV-304 Trial Results
Pfizer and Astellas reported positive data from Phase 3 EV-304 evaluating perioperative enfortumab vedotin (PADCEV) combined with pembrolizumab in muscle-invasive bladder cancer. The combination achieved a 47% reduction in risk of tumor recurrence, progression or death versus neoadjuvant gemcitabine-cisplatin, with 79.4% of patients event-free at two years compared to 66.2%. Overall survival showed a 35% reduction in death risk and pathological complete response reached 55.8% versus 32.5%, consistent across subgroups. The safety profile remained consistent with prior experience, with grade ≥3 adverse events in 75.7% of combination patients versus 67.2% in the chemotherapy arm.
2. RBC Capital Initiates Underperform Rating
RBC Capital initiated coverage of Pfizer with an Underperform rating and set a $25 price target, citing an anticipated $15–20 billion revenue decline through 2030 due to patent expirations and limited near-term pipeline visibility. The firm noted Pfizer’s 6% dividend yield provides some downside support but does not fully offset structural headwinds or a lack of catalysts in 2026.