![]() This is the second indication for KEYTRUDA in esophageal cancer in Japan and is the 16th indication overall. The most commonly observed adverse reactions (≥20%) were nausea in 233 patients (63.0%), decreased appetite in 145 patients (39.2%), anemia in 143 patients (38.6%), fatigue in 135 patients (36.5%), neutrophil count decreased in 135 patients (36.5%), vomiting in 110 patients (29.7%), diarrhea in 97 patients (26.2%), neutropenia and stomatitis in 96 patients (25.9% each) and white blood cell count decreased in 89 patients (24.1%). The Japanese package insert notes that in KEYNOTE-590, adverse reactions were observed in 364 patients (98.4%) out of the safety analysis set of 370 patients (including 73 out of 74 Japanese patients) receiving KEYTRUDA at a dose of 200 mg every three weeks in combination with 5-FU and cisplatin. KEYTRUDA plus chemotherapy 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 chemotherapy alone. ![]() In the KEYNOTE-590 trial, KEYTRUDA in combination with chemotherapy (5-FU plus cisplatin) demonstrated statistically significant improvements in overall survival and progression-free survival versus chemotherapy alone (5-FU plus cisplatin) in chemotherapy-naïve patients with radically unresectable, advanced or recurrent esophageal squamous cell carcinoma or esophageal adenocarcinoma or adenocarcinoma of the esophagogastric junction (Siewert type 1), regardless of histology or PD-L1 expression status. We remain committed to addressing the most challenging cancers affecting Japanese patients and working with the government to provide access to patients in Japan.” ![]() “It is encouraging that now appropriate patients with esophageal cancer have an immunotherapy regimen option with KEYTRUDA earlier in the treatment course that can potentially extend their lives. ![]() “The burden of esophageal cancer is high in Japan, where cases are increasing,” said Kyle Tattle, president, MSD Japan. “This approval offers a new treatment option with KEYTRUDA, which has been shown to improve overall survival and progression-free survival when combined with chemotherapy compared to standard of care chemotherapy as a first-line treatment for patients with radically unresectable, advanced or recurrent esophageal carcinoma.” Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “In Japan, patients living with advanced esophageal cancer face a poor prognosis with current chemotherapy regimens,” said Dr. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the first-line treatment of patients with radically unresectable, advanced or recurrent esophageal carcinoma in combination with chemotherapy (5-fluorouracil plus cisplatin) based on data from the Phase 3 KEYNOTE-590 trial. ![]() KEYTRUDA Is Now Approved for 16 Indications in Japan First Anti-PD-1/L1-Based Regimen Approved in Japan for First-Line Treatment of Advanced Esophageal Cancer ![]()
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