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Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan in Combination With Chemotherapy for First-Line Treatment of Patients With Radically Unresectable, Advanced or Recurrent Esophageal Carcinoma

Published: 2021-11-30 11:45:00 ET
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First Anti-PD-1/L1-Based Regimen Approved in Japan for First-Line Treatment of Advanced Esophageal Cancer

KEYTRUDA Is Now Approved for 16 Indications in Japan

KENILWORTH, N.J.--(BUSINESS WIRE)-- 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 [5-FU] plus cisplatin) based on data from the Phase 3 KEYNOTE-590 trial.

“In Japan, patients living with advanced esophageal cancer face a poor prognosis with current chemotherapy regimens,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “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.”

“The burden of esophageal cancer is high in Japan, where cases are increasing,” said Kyle Tattle, president, MSD 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. We remain committed to addressing the most challenging cancers affecting Japanese patients and working with the government to provide access to patients in Japan.”

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. KEYTRUDA plus chemotherapy reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p