Merck's Keytruda Demonstrates 32% Reduction in Recurrence or Death Risk in Phase 3 Trial for Early-Stage Renal Cell Carcinoma

Today, MSD announced that its blockbuster PD-1 inhibitor Keytruda, as adjuvant therapy, achieved positive results in the Phase 3 KEYNOTE-564 clinical trial for patients with early-stage renal cell carcinoma (RCC). At a median follow-up of 24.1 months, compared with placebo, Keytruda reduced the risk of disease recurrence or death by 32% in patients with RCC who had undergone radical nephrectomy or nephrectomy with resection of metastatic lesions (HR=0.68, 95% CI, 0.53-0.87, p=0.0010). In terms of overall survival, Keytruda was observed to reduce the risk of death by 46% (HR=0.54, 95% CI, 0.30–0.96, p=0.0164).

Renal cell carcinoma is the most common type of kidney cancer, accounting for 90% of all cases. It is estimated that in 2020, there were over 430,000 newly diagnosed kidney cancer cases worldwide, with nearly 180,000 deaths attributed to the disease. MSD's blockbuster PD-1 inhibitor, Keytruda, has already received FDA approval for use in combination with chemotherapy as a first-line treatment for renal cell carcinoma. The combination therapy of Keytruda and the oral tyrosine kinase inhibitor Lenvima has also been granted Priority Review designation by the FDA, and is expected to be approved this summer as a first-line treatment for RCC.

Note: The original text has been abridged.

References:

[1] 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). Retrieved June 3, 2021, from https://www.merck.com/news/mercks-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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