Merck announces results from Phase 3 KEYNOTE-A18 trial

Merck announced results from the pivotal 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 plus concurrent chemotherapy, followed by brachytherapy, for newly diagnosed patients with high-risk locally advanced cervical cancer, stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease. Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, or PFS, compared to concurrent chemoradiotherapy alone for these patients. After a median follow-up of 17.9 months, the KEYTRUDA regimen reduced the risk of disease progression or death by 30% versus concurrent chemoradiotherapy alone in these patients. Median PFS was not reached in either group. The 24-month PFS rate was 67.8% for patients who received the KEYTRUDA regimen compared to 57.3% for those who received concurrent chemoradiotherapy alone. In addition to an improvement in PFS, a favorable trend in overall survival, or OS, the trial’s other primary endpoint, was observed for the KEYTRUDA regimen versus concurrent chemoradiotherapy alone; with only 103 events across both groups, these OS data are not mature and did not reach statistical significance 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. The findings are being presented for the first time today at 10:45 a.m. ET during a late-breaking abstract proffered paper session at the European Society for Medical Oncology, or ESMO, Congress 2023, the company noted.