Merck announced that the Phase 3 KEYNOTE-A18 trial investigating KEYTRUDA in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy met one of its primary endpoints of progression-free survival (PFS) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.

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.

“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. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “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. 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.”

“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. However, there have been limited new treatment advances for these patients beyond the current standard of care in the last 20 years,” said Prof. 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. “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.”

In the U.S., KEYTRUDA has two approved indications in cervical cancer.