Merck's KEYTRUDA® (Pembrolizumab) Achieves Positive Phase 3 Results in Adjuvant Treatment of Renal Cell Carcinoma, Significantly Improving Disease-Free Survival

April 08, 2021 News /BioonBIOON/ -- Merck & Co. recently announced that the pivotal Phase 3 KEYNOTE-564 trial, evaluating the anti-PD-1 therapy Keytruda (KEYTRUDA®, generic name: pembrolizumab) as monotherapy for adjuvant treatment of patients with renal cell carcinoma (RCC), met its primary endpoint of disease-free survival (DFS): compared with the placebo group, the Keytruda treatment group demonstrated statistically significant and clinically meaningful improvement in DFS. Notably, this marks the first positive result for an anti-PD-1 therapy in the adjuvant (post-surgical) setting for RCC patients, confirming the value of Keytruda in early-stage disease treatment.

KEYNOTE-564 is a randomized, double-blind, phase 3Clinical Trials(NCT03142334) is evaluating the efficacy of Keytruda as monotherapy adjuvant treatment for patients with renal cell carcinoma (RCC) at intermediate-high, high risk, or M1 no evidence of disease (M1 NED) status following nephrectomy or nephrectomy and metastasectomy. A total of 950 patients were enrolled in this study and randomized into two groups to receive either Keytruda (200 mg intravenous infusion on Day 1 of each 3-week cycle, for up to 17 cycles) or placebo (intravenous infusion of saline on Day 1 of each 3-week cycle, for up to 17 cycles). The primary endpoint was disease-free survival (DFS), and secondary endpoints included overall survival (OS) and safety.

Based on an interim analysis conducted by the independent data monitoring committee, Keytruda monotherapy demonstrated statistically significant and clinically meaningful improvements in disease-free survival (DFS) compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint of the study. The safety profile of Keytruda in this trial was consistent with previously reported studies. Results will be presented at an upcoming medicalConferenceposted and submitted to regulatory authorities.

Kidney Cancer (Image source: vecteezy.com)

Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Global Head of Clinical Development at Merck & Co., Inc., stated: “Since its initial approval for the treatment of renal cell carcinoma (RCC) nearly two years ago, Keytruda in combination with Inlyta (axitinib)PfizerThe development of combination therapy regimens has become an important first-line treatment option for advanced RCC. These new data represent the findings from our study evaluating the role of Keytruda in helping patients with early-stage disease, and they also mark the first positive results for anti-PD-1 therapy in the adjuvant treatment of RCC patients. We look forward to sharing the results of the KEYNOTE-564 study with the medical community and regulatory authorities as soon as possible.”

Renal cell carcinoma (RCC) is by far the most common type of kidney cancer, accounting for approximately 80% of all kidney cancer cases. The incidence of RCC in men is about twice that in women. Most RCC cases are incidentally detected during imaging examinations for other abdominal conditions. Worldwide, it is estimated that in 2020, newDiagnosisThere were nearly 431,300 cases of kidney cancer and approximately 179,400 deaths from kidney cancer. In the United States alone, it is estimated that there were nearly 76,100 newly diagnosed cases of kidney cancer and approximately 13,800 deaths from kidney cancer in 2021.

Keytruda belongs to the class of PD-(L)1 tumor immunotherapies, a currently highly regarded category of cancer immunotherapy designed to harness the body’s own immune system to fight cancer by blocking the PD-1/PD-L1 signaling pathway, thereby inducing cancer cell death, and offering treatment for multiple typesTumorpotential.

Inlyta is Pfizer’s next-generation targeted therapy for renal cell carcinoma that inhibits tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2, and 3, which may promote tumor growth, angiogenesis, and cancer progression (Tumordiffusion). Sutent, also developed by Pfizer, is a multi-receptor tyrosine kinase inhibitor and has been the standard-of-care first-line treatment for RCC over the past decade.

Currently, the combination regimen of Keytruda and Inlyta has been approved in the United States, Europe, and Japan for the first-line treatment of patients with advanced renal cell carcinoma (RCC). MSD is continuing to investigate Keytruda as a monotherapy and in combination with other cancer treatments across multiple treatment settings and disease stages for RCC through its extensive clinical program.

Original Source: Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery