Merck's Keytruda Achieves DFS Primary Endpoint in Phase III KEYNOTE-123 Trial as Adjuvant Therapy for Locally Muscle-Invasive and Locally Advanced Urothelial Cancer

On October 5, MSD announced that the Phase III KEYNOTE-123 study of pembrolizumab (Keytruda, K drug) as adjuvant treatment for postoperative locally muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma (UC) met its primary endpoint of significantly extending disease-free survival (DFS) at the interim analysis. MSD will continue to evaluate the other primary endpoint of the study—overall survival (OS).

KEYNOTE-123 (A031501/AMBASSADOR) is a randomized, open-label clinical trial sponsored by the National Cancer Institute (NCI), enrolling a total of 702 patients. The study aims to evaluate the efficacy and safety of K drug compared to observation as adjuvant treatment for postoperative localized MIUC and locally advanced UC patients. The primary endpoints include OS and DFS, while secondary endpoints encompass OS and DFS in both PD-L1 positive and negative patients.

"Up to half of bladder cancer patients who undergo surgery will recur within a year, highlighting a significant need for new treatment options in the adjuvant setting. The positive results of this study underscore the potential of Keytruda in preventing postoperative recurrence in patients with locally advanced MIUC or locally advanced UC," said Dr. Marjorie Green, Senior Vice President of Merck & Co., Inc. Research Laboratories and Head of Global Clinical Development for Late-stage Oncology.

For all stages of bladder cancer (including non-muscle-invasive, muscle-invasive, and metastatic), MSD has explored the therapeutic potential of Keytruda as a monotherapy or in combination with other anticancer therapies.

For MIUC, MSD has conducted four Phase III studies: KEYNOTE-866 (K drug + chemotherapy), KEYNOTE-992 (K drug + chemoradiotherapy), KEYNOTE-905 (K drug + Vinblastine Monoclonal Antibody), and KEYNOTE-B15 (K drug + Vinblastine Monoclonal Antibody); for non-invasive UC, MSD has conducted the KEYNOTE-676 (K drug + BCG) study; for metastatic UC, MSD has conducted the IMAGINE (K drug) and LEAP-011 (K drug + Lenvatinib) studies.

It is estimated that there will be approximately 82,290 newly diagnosed cases of bladder cancer in the United States in 2023. About 7% of patients already have locally advanced bladder cancer at the time of diagnosis, while up to 50% of bladder cancer patients experience recurrence within 12 months after surgery. MIUC refers to bladder cancer that has spread to the deep muscle layer of the bladder wall, and locally advanced UC refers to cancer that originates from urothelial cells and spreads to nearby tissues or lymph nodes.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.