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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
    Source:
    Merck (MSD) Press Release
    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:
    FDA
    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:
    NCCN
    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
    Source:
    Merck (MSD) Press Release
    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:
    Ann Oncol
    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:
    KEYNOTE-590