Pfizer Inc. and Astellas Pharma disclosed that the Phase 3 EV‑304 (KEYNOTE‑B15) trial of PADCEV (enfortumab vedotin) combined with Keytruda (pembrolizumab) achieved a 47 % reduction in the risk of tumor recurrence, progression or death among cisplatin‑eligible patients with muscle‑invasive bladder cancer. The primary endpoint, event‑free survival, was 79.4 % at two years in the combination arm versus 66.2 % in the standard‑of‑care arm.
The study also reported a 55.8 % pathological complete response rate compared with 32.5 % in the chemotherapy group, and a 35 % reduced risk of death (hazard ratio 0.65) in the combination arm. These outcomes were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium on February 27, 2026, and the companies plan to discuss the data with global health authorities for potential regulatory filings.
The results position PADCEV plus Keytruda as a strong contender to replace platinum‑based chemotherapy, the current standard of care, and could create a new standard for muscle‑invasive bladder cancer. The data also validate Pfizer’s strategy to expand its antibody‑drug conjugate (ADC) platform following the acquisition of Seagen, which brought PADCEV into Pfizer’s portfolio.
Pfizer reaffirmed its full‑year 2026 financial guidance on February 3, 2026, citing a robust pipeline and strategic investments that include the PADCEV/Keytruda data. Chief Executive Officer Albert Bourla highlighted that 2026 would be a key year for catalysts such as the PADCEV trial, while Chief Financial Officer David Denton emphasized disciplined commercial execution and the company’s ability to maintain earnings momentum.
The trial’s success could open a significant revenue opportunity in the bladder‑cancer market, where platinum‑based chemotherapy has dominated for decades. By potentially establishing a new standard of care, Pfizer could capture a larger share of the market and strengthen its oncology portfolio, reinforcing its position as a leader in ADC therapeutics.
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