▎The content team editor of WuXi AppTec today, Merck & Co.
(MSD) announced that its blockbuster PD-1 inhibitor Keytruda, as an adjuvant therapy, was obtained in the Phase 3 clinical trial KEYNOTE-564 for the treatment of patients with early renal cell carcinoma (RCC) Positive results.
At a median follow-up time of 24.
1 months, Keytruda reduced the risk of recurrence or death by 32% in patients with renal cell carcinoma who had undergone total nephrectomy or renal and metastatic lesions compared with placebo (HR= 0.
68, 95% CI, 0.
In terms of overall survival, Keytruda was observed to reduce the risk of death by 46% (HR=0.
54, 95% CI, 0.
Renal cell carcinoma is the most common kidney cancer, accounting for 90% of the total number of kidney cancers.
It is estimated that there will be more than 430,000 newly diagnosed kidney cancer patients worldwide in 2020, and nearly 180,000 of them will die as a result.
Merck’s blockbuster PD-1 inhibitor Keytruda has been approved by the FDA for the first-line treatment of renal cell carcinoma in combination with chemotherapy.
The combination therapy consisting of Keytruda and the oral tyrosine kinase inhibitor Lenvima has also been granted priority review by the FDA and is expected to be approved this summer for the first-line treatment of RCC.
"Approximately half of patients with early-stage renal cell carcinoma have disease recurrence after undergoing surgery.
We are very pleased to see that Keytruda significantly reduced the risk of disease recurrence and death by 32% compared with placebo in this study.
"Scot Ebbinghaus, vice president of clinical research at Merck Laboratories, said, "These data show that Keytruda has the potential to become a new standard treatment for patients with early renal cell carcinoma.
We will work closely with regulatory agencies to bring this treatment option to patients.
"Reference:  Merck's KEYTRUDA® (pembrolizumab) Given After Surgery Reduced the Risk of Disease Recurrence or Death by 32% Versus Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC).
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