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Phase III KEYNOTE-564 trial: Keytruda after surgery reduced risk of recurrence or death by 32% in RCC

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Keytruda (pembrolizumab) demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; p=0.0010) as a potential adjuvant treatment of renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. 

After a median follow-up of 24.1 months (14.9-41.5), Keytruda demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; p=0.0010).

Data from the phase III KEYNOTE-564 trial also demonstrated a 46% reduction in the risk of death with KEYTRUDA as compared to placebo (HR=0.54 [95% CI, 0.30–0.96]; p=0.0164). The trial will continue to evaluate OS, a key secondary endpoint.

The late-breaking results were presented in the plenary session of the 2021 American Society of Clinical Oncology annual meeting (Abstract #LBA5). 

Keytruda is approved in the U.S., Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.

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