▎WuXiEdited by Kant Content Team

Recently, the prestigious medical journal *The New England Journal of Medicine* published the overall survival (OS) results of MSD's pivotal phase 3 clinical trial KEYNOTE-564 for its PD-1 targeted therapy Keytruda (pembrolizumab).The trial analysis showed that Keytruda significantly improved OS in patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence after nephrectomy or nephrectomy and metastasectomy, reducing the risk of death by 38%.

KEYNOTE-564 is a randomized, double-blind Phase 3 clinical trial designed to evaluate the adjuvant treatment effect of Keytruda in patients who have undergone nephrectomy and whose disease is at intermediate-high risk, high risk, or M1 with no evidence of disease (NED) RCC. The primary endpoint is disease-free survival (DFS) assessed by investigator review, and secondary endpoints include OS and safety. The study enrolled a total of 994 patients, who were randomly assigned in a 1:1 ratio to receive either Keytruda (intravenous injection of 200 mg on Day 1 of each three-week cycle for up to 17 cycles) or placebo (intravenous injection of saline on Day 1 of each three-week cycle for up to 17 cycles).

At a median follow-up time of 57.2 months, Keytruda significantly improved DFS in patients as an adjuvant therapy.Keytruda as an adjuvant therapy reduced the risk of disease recurrence or death by 28% (HR=0.72, 95% CI: 0.59-0.87).At the same time,Keytruda Improves Overall Survival in Patients, Reducing the Risk of Death by 38% Compared to the Placebo Group (HR=0.62, 95% CI: 0.44-0.87; P=0.005).At 48 months, the estimated overall survival rate for patients receiving Keytruda was 91.2%, compared to 86.0% in the placebo group. Consistent benefits were observed across all major subgroups.

The incidence of serious adverse events with Keytruda for any reason was higher at 20.7%, compared to 11.5% in the placebo group. The rate of grade 3 or 4 adverse events related to Keytruda was 18.6%, versus 1.2% for placebo. No patients died as a result of treatment with Keytruda.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes and enhancing the ability of the body's immune system to detect and combat tumor cells.Keytruda has been approved in the United States, Europe, and Japan for use in combination with axitinib as a first-line treatment for patients with advanced RCC. Additionally, based on the DFS data from the KEYNOTE-564 trial announced in 2021, Keytruda has received approval in the United States, the European Union, Japan, and other countries and regions worldwide for adjuvant treatment of RCC patients.

References:

[1] Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Chang YH, Lee JL, Sarwar N, Haas NB, Gurney H, Sawrycki P, Mahave M, Gross-Goupil M, Zhang T, Burke JM, Doshi G, Melichar B, Kopyltsov E, Alva A, Oudard S, Topart D, Hammers H, Kitamura H, McDermott DF, Silva A, Winquist E, Cornell J, Elfiky A, Burgents JE, Perini RF, Powles T; KEYNOTE-564 Investigators. Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma. N Engl J Med. 2024 Apr 18;390(15):1359-1371. doi: 10.1056/NEJMoa2312695. PMID: 38631003.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.