Merck presented new data on Keytruda (pembrolizumab) in patients with cervical cancer. The Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, focused on investigating the use of Keytruda in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (concurrent chemoradiotherapy) for newly diagnosed patients with high-risk locally advanced cervical cancer.
The trial demonstrated a favourable outcome during a prespecified interim analysis conducted by an independent Data Monitoring Committee. Keytruda, when combined with concurrent chemoradiotherapy, met one of its primary endpoints by showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone.
The trial also observed a positive trend in overall survival (OS), another primary endpoint. However, these OS data were not fully mature during the interim analysis. The study is ongoing, and further follow-up on OS is being conducted.
Regarding safety, the Keytruda profile in this trial remained consistent with previously reported studies, and no new safety concerns were identified. Merck plans to present the detailed results of the trial at an upcoming medical meeting and will submit the findings to regulatory authorities for further evaluation.
In the United States, Keytruda has two approved indications for cervical cancer treatment. It can be combined with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Additionally, Keytruda can be used as a single agent for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumours express PD-L1 (CPS ≥1) as determined by an FDA-approved test.