Merck & Co. announced that the U.S. Food and Drug Administration approved a new combination therapy consisting of KEYTRUDA® (pembrolizumab), KEYTRUDA QLEX™ (subcutaneous pembrolizumab plus berahyaluronidase alfa‑pmh), and Padcev® (enfortumab vedotin‑ejfv) for neoadjuvant and adjuvant treatment of adults with cis‑platin‑ineligible muscle‑invasive bladder cancer.
The approval is based on the KEYNOTE‑905 (EV‑303) trial, which showed a 57.1% pathologic complete response rate versus 8.6% with standard care, a 60% reduction in the risk of event‑free survival events, and a 50% improvement in overall survival. These results demonstrate a clinically meaningful benefit for a population with limited options.
Merck’s oncology business remains a key driver of its financial performance. In the third quarter of 2025, the company reported worldwide sales of $17.3 billion, up 4% year‑over‑year, and net income of $5.8 billion, an 83% increase. Keytruda sales grew 10% to $8.1 billion, underscoring the drug’s central role in the oncology portfolio.
Strategically, the new indication positions Merck as the first PD‑1 inhibitor combined with an antibody‑drug conjugate for this patient group, strengthening its competitive stance against rivals such as Pfizer and AstraZeneca. The combination also diversifies revenue streams and extends the life‑cycle of the KEYTRUDA platform as patent expirations approach.
Dr. Matthew Galsky, a study investigator from Mount Sinai Tisch Cancer Center, noted that “Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin. These approvals, based on striking event‑free and overall survival benefits, may represent an important practice‑changing advance.”
Merck updated its 2025 guidance to anticipate worldwide sales between $64.5 billion and $65.0 billion, reflecting confidence that the new bladder‑cancer indication will contribute to future revenue growth.
The approval underscores Merck’s commitment to expanding its oncology portfolio and leveraging combination therapies to address unmet medical needs in high‑risk patient populations.
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