Title:
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
Excerpt:Merck...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.
Secondary therapy:cisplatin + 5-fluorouracil
Title:
Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy for First-Line Treatment of Patients With Locally Advanced Unresectable or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma
Excerpt:Merck...today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ).
Excerpt:KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...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 either:...in combination with platinum- and fluoropyrimidine-based
chemotherapy...
Evidence Level:Sensitive: A2 - Guideline
New
Excerpt:Esophageal and Esophagogastric Junction Cancers: First-line Therapy...Preferred Regimens...Fluoropyrimidine (fluorouracil or capecitabine), cisplatin, and pembrolizumab…
Secondary therapy:cisplatin + capecitabine; cisplatin + 5-fluorouracil
Evidence Level:Sensitive: B - Late Trials
Title:
Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study
Excerpt:Compared with placebo plus chemotherapy, pembrolizumab plus chemotherapy improved overall survival in patients with previously untreated, advanced oesophageal squamous cell carcinoma...
DOI:10.1016/S0140-6736(21)01234-4
Evidence Level:Sensitive: B - Late Trials
Title:
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Cancer
Excerpt:Merck...today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ).
Evidence Level:Sensitive: B - Late Trials
Title:
LBA8_PR - Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study
Excerpt:Pembro + chemo provided superior OS, PFS, and ORR vs chemo, with a manageable safety profile in pts with untreated, advanced esophageal and EGJ cancer.
DOI:10.1016/annonc/annonc325
Evidence Level:Sensitive: B - Late Trials
Title:
Merck’s KEYTRUDA (pembrolizumab) Plus Chemotherapy Reduced Risk of Death by 27% Versus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Esophageal Cancer
Excerpt:MSD outside the United States and Canada, today announced first-time data from the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer.
Secondary therapy:cisplatin + 5-fluorouracil