gaqdrug.blogg.se - Keynote maximum action duration

Patients could be treated with KEYTRUDA for up to 24 months in the absence of disease progression. Treatment with KEYTRUDA or chemotherapy continued until unacceptable toxicity or disease progression.

Placebo on Day 1 of each 3-week cycle in combination with cisplatin 80 mg/m 2 IV on Day 1 of each 3-week cycle for up to 6 cycles and FU 800 mg/m 2 IV per day on Day 1 to Day 5 of each 3-week cycle, or per local standard for FU administration, for up to 24 months.

KEYTRUDA 200 mg on Day 1 of each 3-week cycle in combination with cisplatin 80 mg/m 2 IV on Day 1 of each 3-week cycle for up to 6 cycles and FU 800 mg/m 2 IV per day on Day 1 to Day 5 of each 3-week cycle, or per local standard for FU administration, for up to 24 months.

Patients were randomized (1:1) to one of the following treatment arms all study medications were administered via IV infusion: ex-Asia), and ECOG performance status (0 vs. adenocarcinoma), geographic region (Asia vs.

Randomization was stratified by tumor histology (squamous cell carcinoma vs.

Patients with active autoimmune disease, a medical condition that required immunosuppression, or who received prior systemic therapy in the locally advanced or metastatic setting were ineligible. PD⁠-⁠L1 status was centrally determined in tumor specimens in all patients using the PD⁠-⁠L1 IHC 22C3 pharmDx kit. The efficacy of KEYTRUDA was investigated in KEYNOTE⁠-⁠590, a multicenter, randomized, placebo-controlled trial that enrolled 749 patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation.