Merck's KEYNOTE-123 Phase III Trial of Keytruda as Adjuvant Therapy in Locally Advanced or Muscle-Invasive Urothelial Cancer Meets Primary DFS Endpoint-VCBeat

On October 5, MSD announced that the Phase III KEYNOTE-123 study of pembrolizumab (Keytruda, K drug) as adjuvant therapy 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) study is a randomized, open-label clinical trial sponsored by the National Cancer Institute (NCI), enrolling a total of 702 patients, aiming toEvaluate the efficacy and safety of K drug versus observation as adjuvant therapy in patients with localized MIUC and locally advanced UC post-surgery. The primary endpoints include OS and DFS, with secondary endpoints including OS and DFS in PD-L1 positive and negative patients.

Marjorie Green, Ph.D., Senior Vice President of Merck & Co., Inc. Research Laboratories and Head of Global Clinical Development for Late-Stage OncologyDoctor said:"Up to half of bladder cancer patients who undergo surgery will experience a recurrence within one year, highlighting the urgent need for new treatment options in the adjuvant setting.""The positive results of this study highlight Keytruda's potential in preventing postoperative recurrence in patients with locally advanced MIUC or locally advanced UC."

For All Stages of Bladder Cancer（Including non-muscle invasiveSex, MuscleInfiltrationSexuality and metastasis)MSD has explored the therapeutic potential of K drug as a monotherapy or in combination with other anticancer therapies.

For MIUC, MSD has launchedKEYNOTE-866 (K drug + chemotherapy),KEYNOTE-992 (K drug + chemoradiotherapy),KEYNOTE-905(K drug + Ventuzumab) andKEYNOTE-B15（K Medicine+Vientoyou SingleAnti-) 4 Phase III studies; for non-invasive UC, MSD has conductedKEYNOTE-676 (K drug + BCG) study; for metastatic UC, MSD has launchedIMAGINE(K drug) andLEAP-011 (K Drug + Lenvatinib) Study。

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 will have locally advanced disease at the time of diagnosis.Bladder Cancer,AndUp to 50% of bladder cancer patients post-surgeryRecurrence within 12 monthsMIUC refers to bladder cancer that has spread to the deep muscle of the bladder wall, and locally advanced UC refers to cancer that originates from urothelial cells and spreads to nearby tissues or lymph nodes.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position;For reprint, please leave a message to the WeChat Official Account backstage or send a message, and indicate 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.

Medcube Reader Survey Questionnaire

Thank You for Your Support! We Look Forward to Your Feedback

Scan the QR code to provide valuable suggestions