Merck Announces Phase 3 KEYNOTE- 859 Trial Met Primary Endpoint of Overall Survival in Cases With HER2-Negative Gastric or Gastroesophageal Junction( GEJ) Adenocarcinoma
RAHWAY,N.J.–( BUSINESS WIRE)– Merck( NYSE MRK), known as MSD outside of the United States and Canada, moment blazoned positive topline results from the vital Phase 3 KEYNOTE- 859 trial probing KEYTRUDA, Merck’santi-PD-1 remedy, in combination with chemotherapy for the first- line treatment of cases with mortal epidermal growth factor receptor 2( HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. KEYTRUDA in combination with chemotherapy showed a statistically significant and clinically meaningful enhancement in the trial’s primary endpoint of overall survival( zilches) versus chemotherapy alone in the each- randomized patient population at apre-specified interim analysis conducted by an independent Data Monitoring Committee. Statistically significant and clinically meaningful advancements in progression-free survival( PFS) and overall response rate( ORR) were also observed in the each- randomized patient population.
The safety profile of KEYTRUDA in this trial was harmonious with that observed in preliminarily reported studies; no new safety signals were linked. Results will be presented at an forthcoming medical meeting and will be submitted to nonsupervisory authorities.
“ Despite advancements in cancer care, advanced gastric cancer continues to have one of the smallest five- time survival rates, and new interventions are urgently demanded. The results from KEYNOTE- 859 show the eventuality of KEYTRUDA plus chemotherapy to ameliorate survival beyond chemotherapy alone for cases with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, anyhow of PD- L1 expression, ” saidDr. Eliav Barr, elderly vice chairman and head of global clinical development, principal medical officer, Merck Research Laboratories. “ We’re agitated by these new results that demonstrate our commitment to exploring new treatment options for cases fighting gastrointestinal cancers with KEYTRUDA and thank all investigators and cases who shared in this trial. ”
Merck has an expansive clinical development program assessing KEYTRUDA in gastrointestinal cancers, which includes KEYNOTE- 811 in first- line advanced HER2-positive gastric cancer, KEYNOTE- 585 in early- stage gastric cancer, and farther disquisition in advanced/ metastatic gastric cancer in vault- 015. Merck is continuing to study KEYTRUDA for multiple uses in hepatobiliary, esophageal, pancreatic and colorectal cancers.
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