The trial enrolled 1,060 patients who were randomized to receive: The primary endpoints are PFS and OS, and secondary endpoints include complete response (CR) rate, objective response rate (ORR) and safety. (GOG) evaluating KEYTRUDA in combination with EBRT plus concurrent chemotherapy (cisplatin), followed by brachytherapy (also known as concurrent chemoradiotherapy) compared to placebo plus concurrent chemoradiotherapy for the treatment of newly diagnosed high-risk (stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease) locally advanced cervical cancer where patients are treated with definitive intent. KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized, double-blind Phase 3 trial (, NCT04221945) sponsored by Merck and conducted in collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. In the U.S., KEYTRUDA has two approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test and as a single agent, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. “These results are very encouraging and support the use of pembrolizumab combined with the current standard of care in locally advanced cervical cancer to help address the need for new treatment options beyond chemoradiotherapy alone.” Domenica Lorusso, the study’s overall principal investigator, lead investigator for ENGOT, and associate professor of Obstetrics and Gynecology at the Catholic University of Rome. However, there have been limited new treatment advances for these patients beyond the current standard of care in the last 20 years,” said Prof. “Patients with high-risk locally advanced cervical cancer often have a poor prognosis, with more than half of patients experiencing disease recurrence within two years. We thank the patients, investigators and our partners at ENGOT and GOG for their important contributions to this study and look forward to sharing these results with the medical community.” “We are encouraged by these results that show treatment with KEYTRUDA significantly improved progression-free survival for patients with newly diagnosed high-risk locally advanced cervical cancer. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. ![]() “The role of KEYTRUDA is already established in certain patients with persistent, recurrent or metastatic cervical cancer, and these results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes,” said Dr. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies no new safety signals were identified. The trial is continuing and follow-up of OS is ongoing. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent chemoradiotherapy showed a statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone.Ī favorable trend in overall survival (OS), the trial’s other primary endpoint, was also observed for KEYTRUDA plus concurrent chemoradiotherapy compared to concurrent chemoradiotherapy alone however, these OS data were not mature at the time of this interim analysis. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) met one of its primary endpoints of progression-free survival (PFS) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer. KEYTRUDA ® (pembrolizumab) plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients
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