![]() “There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. “Today’s approval of this indication for KEYTRUDA introduces a new option, which has shown a superior survival benefit compared to FU and cisplatin alone, for newly diagnosed patients with locally advanced or metastatic esophageal or GEJ carcinoma that is not amenable to surgical resection or definitive chemoradiation, regardless of PD-L1 expression status and tumor histology.” Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center. “Because esophageal cancer generally has poor survival rates, new first-line therapies are urgently needed for these patients,” said Dr. ![]() For more information, see “Selected Important Safety Information” below. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. The ORR, an additional efficacy outcome measure, was 45% (95% CI, 40-50) for patients who received KEYTRUDA plus FU and cisplatin and 29% (95% CI, 25-34) for those who received FU and cisplatin alone (p<0.0001). ![]() For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 p<0.0001) versus FU and cisplatin alone. The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression
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