Merck today presented the results of a Phase III trial evaluating Keytruda as adjuvant treatment for patients with localized muscular invasive urothelial carcinoma (MIUC) and locally advanced resectable urothelial carcinoma.

In the first interim analysis, after a median follow-up of 22.3 months, Keytruda demonstrated a 'statistically and clinically significant' improvement in disease-free survival (DFS), one of the study's two primary endpoints.

In fact, the treatment reduced the risk of disease recurrence or death by 31% compared with observation of patients after surgery.

However, the other primary endpoint - overall survival (OS) - did not reach statistical significance at the time of this interim analysis.
Thus, after a median follow-up of 36.9 months, median OS was 50.9 months for Keytruda versus 55.8 months for the post-surgery observation.

Overall survival will therefore continue to be monitored as the data mature, reports the laboratory.

The results of this pivotal study support Keytruda as a potential new adjuvant option for these patients, and demonstrate its growing role in early-stage bladder cancer," said Dr. Marjorie Green, Senior Vice President and Head of Oncology and Global Clinical Development at Merck Research Laboratories.

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