Merck disclosed that the Phase 3 KEYNOTE‑B15 trial of its PD‑1 inhibitor KEYTRUDA® in combination with the antibody‑drug conjugate Padcev® met its primary endpoint of event‑free survival in cis‑platin‑eligible muscle‑invasive bladder cancer (MIBC) patients. The study also achieved key secondary endpoints, including overall survival and pathologic complete response, in a perioperative setting that does not require platinum‑based chemotherapy. The trial was conducted in partnership with Pfizer and Astellas, who co‑develop Padcev® for bladder cancer indications.
The survival benefit is clinically meaningful for a high‑need population. Dr. Matthew Galsky, principal investigator, noted that “the persistent risk of recurrence in cis‑eligible patients with muscle‑invasive bladder cancer underscores the need for effective perioperative treatments, and the strength of these data demonstrates that pembrolizumab plus enfortumab vedotin can significantly improve survival outcomes.” The results suggest that the combination could become a new standard of care for patients who are not candidates for cisplatin or who benefit from earlier intervention.
From a business perspective, the data support a label expansion for KEYTRUDA® into earlier stages of bladder cancer, a move that could generate additional revenue streams and help offset the 2028 patent cliff for the drug. Merck’s senior vice president of oncology, Dr. Marjorie Green, said the findings “reinforce our conviction that moving Keytruda into earlier stages of cancer care can make a meaningful difference for patients.” The trial’s success also bolsters Merck’s broader oncology pipeline, reinforcing its strategy to deliver clinical breakthroughs across multiple indications.
The collaboration with Pfizer and Astellas positions Merck to pursue regulatory submissions worldwide, leveraging existing approvals of the KEYTRUDA‑Padcev combination for locally advanced or metastatic urothelial cancer and cisplatin‑ineligible MIBC. The new data provide a strong foundation for future submissions and could accelerate the drug’s commercial rollout in the perioperative setting, further diversifying Merck’s oncology portfolio.
Although immediate market reaction data are not available, the KEYNOTE‑B15 topline results represent a material development that could influence Merck’s future earnings and market positioning. The trial’s success underscores the company’s ability to secure new indications for its flagship product and strengthens its competitive stance in the bladder‑cancer market.
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