March 15,MSDAnnouncement, in a pre-specified interim analysis conducted by the Independent Data Monitoring Committee (IDMC),Pembrolizumab (Keytruda，K Drug)UnitedConcurrent chemoradiotherapy (CRT) Treatment of Newly Diagnosed High-Risk Locally Advanced Cervical Cancer Patients in Phase IIIKEYNOTE-A18 Study Achieved the OverallOverall Survival (OS)The main finalKeytruda+CRT is the first immunotherapy regimen to demonstrate a statistically significant difference in OS for these patients.
KEYNOTE-A18 (also known as ENGOT-cx11/GOG-3047) is a randomized, double-blind Phase III clinical trial designed to evaluate MSD's PD-1 inhibitor pembrolizumab in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy followed by brachytherapy (i.e., concurrent chemoradiotherapy), compared with placebo plus concurrent chemoradiotherapy, for the treatment of newly diagnosed high-risk locally advanced (i.e., stage IB2-IIB with positive lymph nodes and stage III-IVA with or without lymph node involvement) cervical cancer patients. The primary endpoints of the study are progression-free survival and overall survival, with secondary endpoints including complete response rate, objective response rate, and safety.Keytruda in combination with concurrent CRT showed statistically significant improvement in OS compared to concurrent CRT alone.SexAnd clinically significant improvements. In this trialKeytrudaThe safety profile is consistent with previously reported study findings, with no new safety signals identified. MSD stated that the study results will be presented at an upcoming medical conference and shared with...Shared by global regulatory agencies.In July last year, the KEYNOTE-A18 study met its primary endpoint of progression-free survival (PFS). These PFS data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and supported the U.S. FDA in January 2024.Approval of Keytruda in combination with CRT for the treatment of cervical cancer patients staged III-IVA according to the 2014 FIGO (International Federation of Gynecology and Obstetrics) classification.Previously, K drug received two other FDA approvals for cervical cancer indications: 1) as a single agent for patients with recurrent or metastatic cervical cancer whose disease has progressed during or after chemotherapy and whose tumors express PD-L1 (CPS≥1); 2) in combination with chemotherapy, with or without...Bevacizumab, for the treatment of tumors expressing PD-L1（CPS ≥1）Patients with persistent, recurrent, or metastatic cervical cancer.Copyright © 2024 PHARMCUBE. All Rights Reserved.Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article.For reprint, please leave a message or send a message to the WeChat Official Account backend, 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 used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.
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