^
    Back
    Association details:
    Biomarker:No biomarker
    Cancer:Esophageal Adenocarcinoma
    Drug:Opdivo (nivolumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    05/20/2021
    Excerpt:
    OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    04/16/2021
    Excerpt:
    OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of...patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.
    Secondary therapy:
    Modified FOLFOX6; CAPOX
    Trial ID:
    CheckMate649
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Int J Cancer
    Title:

    First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis

    Published date:
    09/19/2022
    Excerpt:
    Consistent with results from the global primary analysis of CheckMate 649, nivolumab plus chemotherapy demonstrated a clinically meaningful improvement in OS and PFS and higher response rate vs chemotherapy and an acceptable safety profile in Chinese patients. Nivolumab plus chemotherapy represents a new standard first-line treatment for Chinese patients with non-HER2-positive advanced GC/GEJC/EAC.
    Secondary therapy:
    FOLFOX; capecitabine + oxaliplatin
    DOI:
    10.1002/ijc.34296
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma

    Published date:
    01/20/2021
    Excerpt:
    Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.
    Secondary therapy:
    Chemotherapy
    Trial ID:
    CheckMate649