FDA approves Keytruda + platinum- and fluoropyrimidine-based chemotherapy to treat locally advanced or metastatic esophageal or gastroesophageal junction carcinoma.- Merck Inc.

Merck Inc., has announced that the 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. The approval is based on results from the Phase III 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. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (hr="0.65" [95% ci, 0.55-0.76]; p><0.0001) versus fu and cisplatin alone.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). 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. 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. early identification and management of immune-mediated adverse reactions are essential to ensure safe use of keytruda. based on the severity of the adverse reaction, keytruda should be withheld or permanently discontinued and corticosteroids administered if appropriate. keytruda can also cause severe or life-threatening infusion-related reactions. based on its mechanism of action, keytruda can cause fetal harm when administered to a pregnant woman. .>