KEYNOTE-A18 Trial: Primary Endpoint – Progression-Free Survival in High-Risk Cervical Cancer

Merck’s KEYNOTE-A18 Trial Shows Breakthrough in Cervical Cancer Treatment

Source – Merck

Merck has announced a groundbreaking development in its Phase III KEYNOTE-A18 trial, also referred to as ENGOT-cx11/GOG-3047. This trial focuses on investigating the potential of Keytruda, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) and concurrent chemotherapy, followed by brachytherapy (concurrent chemoradiotherapy), as a treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.

During a preplanned interim analysis conducted by an independent Data Monitoring Committee, the combination of Keytruda with concurrent chemoradiotherapy demonstrated a significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone.

Furthermore, the trial also observed a positive trend in overall survival (OS), another primary endpoint, for Keytruda in combination with concurrent chemoradiotherapy. However, the data for OS were not yet fully mature at the time of this interim analysis, and the trial is ongoing with continued follow-up.

“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. 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.”

– Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories

“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. 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.”

– 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

The safety profile of Keytruda in this trial remained consistent with findings from previous studies, with no new safety signals identified. These promising results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities for further evaluation.

In the United States, Keytruda is already approved for two indications in cervical cancer treatment. Firstly, in combination with chemotherapy (with or without bevacizumab) for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Secondly, as a single agent for 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.

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