Merck announces Phase 3 KEYNOTE-A18 trial met one primary endpoint

Merck 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, or EBRT, plus concurrent chemotherapy, followed by brachytherapy met one of its primary endpoints of progression-free survival, or 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. A favorable trend in overall survival, or 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. The trial is continuing and follow-up of OS is ongoing. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.