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Merck's Keytruda Phase 3 Trial Meets Primary Endpoint In Gastric Cancer Patients

  • 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.

  • Related: Five-Year Data For Merck's Keytruda Plus Chemo Shows Sustained Survival Benefit In Lung Cancer Patients.

  • 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.

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