The trial enrolled 1,579 patients who were randomized to receive KEYTRUDA (200 mg every three weeks for up to approximately two years) in combination with fluoropyrimidine- and platinum-containing chemotherapy (n=785), or placebo in combination with chemotherapy (n=787). The primary endpoint is OS, and secondary endpoints include progression-free survival, ORR, duration of response and safety. KEYNOTE-859 is a randomized, double-blind Phase 3 trial (, NCT03675737) evaluating KEYTRUDA in combination with chemotherapy compared to placebo in combination with chemotherapy for the first-line treatment of patients with HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Merck is continuing to study KEYTRUDA for multiple uses in hepatobiliary, esophageal, pancreatic, colorectal and biliary tract cancers. 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This indication was approved by the FDA under accelerated approval based on tumor response rate and durability of response data from the Phase 3 KEYNOTE-811 study. KEYTRUDA is currently approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in the U.S. "We are committed to working closely with the FDA to bring KEYTRUDA to more patients with gastric and gastroesophageal junction cancer who are in need of additional treatment options that may help them live longer." Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. "The five-year survival rate for patients diagnosed with metastatic gastric cancer is estimated to be only six percent, and eighty percent of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma have HER2-negative disease," said Dr. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 16, 2023. The sBLA is based on data from the KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone, regardless of PD-L1 expression, in patients who were human epidermal growth factor receptor 2 (HER2) negative. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. RAHWAY, N.J., April 13, 2023-( BUSINESS WIRE)-Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |