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Association details:
Biomarker:No biomarker
Cancer:Gastroesophageal Junction Adenocarcinoma
Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
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

Published date:
09/07/2021
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).
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
03/22/2021
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...
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
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:

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

Published date:
12/17/2020
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).
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

LBA8_PR - Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study

Published date:
09/21/2020
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.
Secondary therapy:
Chemotherapy
DOI:
10.1016/annonc/annonc325
Trial ID: