Merck & Co Inc (NYSE: MRK) has announced topline results from the pivotal Phase 3 KEYNOTE-859 trial of its flagship anti-PD-1 therapy, Keytruda, in gastric or Gastroesophageal Junction GEJ adenocarcinoma.
The trial evaluated Keytruda in combination with chemotherapy for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
Keytruda + chemo combo showed a statistically significant and clinically meaningful improvement in the trial's primary endpoint of overall survival (OS) versus chemotherapy.
Statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall response rate (ORR) were also observed in the all-randomized patient population.
No new safety signals were identified.
Merck has an extensive clinical development program evaluating Keytruda in gastrointestinal cancers, which includes KEYNOTE-811 in first-line advanced HER2-positive gastric cancer, KEYNOTE-585 in early-stage gastric cancer, and further exploration in advanced/metastatic gastric cancer in LEAP-015.
Price Action: MRK shares are up 1.14% at $106.82 on the last check Tuesday.
See more from Benzinga
Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.