ESMO 2024: Merck & Co Phase III KEYNOTE-811 trial Keytruda results

US pharma giant Merck & Co (NYSE: MRK) announced positive overall survival (OS) results from the final analysis of the Phase III KEYNOTE-811 trial.

The study, presented at the European Society for Medical Oncology (ESMO) Congress 2024, evaluated Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

After a median follow-up of 50.2 months (range, 31.1-64.4), the Keytruda regimen demonstrated a statistically-significant and clinically-meaningful improvement in OS in the intention-to-treat (ITT) HER2-positive advanced gastric or GEJ study population, reducing the risk of death by 20% (HR=0.80 [95% CI, 0.67-0.94]; p=0.0040 [p-value bound 0.0201]) compared to trastuzumab and chemotherapy alone. For patients who received the Keytruda regimen, median OS was 20.0 months (95% CI, 17.8-22.1) versus 16.8 months (95% CI, 14.9-18.7) for patients receiving trastuzumab plus chemotherapy alone.