Five year positive follow up of CHECKMATE 025 study of Opdivo versus everolimus for metastatic renal cell carcinoma .- BMS
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Eisai Co., Ltd. and Merck & Co., Inc., announced new investigational data from the pivotal Phase III CLEAR(Study 307)/KEYNOTE-581 trial, which evaluated the combinations of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor plus Keytruda, the anti-PD-1 therapy from Merck Inc., and Lenvima plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Merck Inc., announced first-time results from the pivotal Phase III KEYNOTE-564 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney) 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).
Merck Inc and Eisai announced that the FDA has accepted and granted priority review for applications seeking a new approval for the combination of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.