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Merck: Phase 3 KEYNOTE-859 Trial Meets Primary Endpoint Of Overall Survival

Merck (MRK) reported positive topline results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. In the trial, KEYTRUDA in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival versus chemotherapy alone in the all-randomized patient population at a pre-specified interim analysis conducted by an independent Data Monitoring Committee. Statistically significant and clinically meaningful improvements in progression-free survival and overall response rate were also observed. The safety profile was consistent with that observed in previously reported studies.

"The results from KEYNOTE-859 show the potential of KEYTRUDA plus chemotherapy to improve survival beyond chemotherapy alone for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 expression," said Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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