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    Association details:
    Biomarker:HER-2 negative
    Cancer:Gastric Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Published date:
    11/16/2023
    Excerpt:
    KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated...in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
    Secondary therapy:
    Chemotherapy
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet Oncol
    Title:

    Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

    Published date:
    10/19/2023
    Excerpt:
    Participants in the pembrolizumab plus chemotherapy group had a significant and clinically meaningful improvement in overall survival with manageable toxicity compared with participants in the placebo plus chemotherapy group. Therefore, pembrolizumab with chemotherapy might be a first-line treatment option for patients with locally advanced or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma.
    Secondary therapy:
    CF + CAPOX
    DOI:
    10.1016/S1470-2045(23)00515-6
    Trial ID:
    KEYNOTE-859
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Merck (MSD) Press Release
    Title:

    Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Regardless of PD-L1 Expression

    Published date:
    02/16/2023
    Excerpt:
    Merck...announced results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. After a median follow-up of 31.0 months (range, 15.3-46.3 months), KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS), reducing the risk of death by 22% (HR=0.78 [95% CI, 0.70-0.87]; p<0.0001) compared to chemotherapy alone for these patients, regardless of PD-L1 expression. Median OS was 12.9 months (95% CI, 11.9-14.0) for KEYTRUDA plus chemotherapy versus 11.5 months (95% CI, 10.6-12.1) for chemotherapy alone.
    Secondary therapy:
    CF; CAPOX
    Trial ID:
    KEYNOTE-859
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)

    Excerpt:
    ...- triple negative breast cancer (estrogen, progesterone, and human epidermal growth factor receptor 2 [HER2] negative)...
    Trial ID:
    KEYNOTE-012
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

    Excerpt:
    ...- Has human epidermal growth factor receptor 2 (HER2) negative cancer...
    Trial ID:
    KEYNOTE-859
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma

    Excerpt:
    ......
    Trial ID:
    NCT04089904
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)

    Excerpt:
    ...- HER2/neu negative...
    Trial ID:
    KEYNOTE-059
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

    Excerpt:
    ...- Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines....
    Trial ID:
    KEYNOTE-037
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension

    Excerpt:
    ...- Has human epidermal growth factor receptor 2 (HER2) negative cancer...
    Trial ID:
    KEYNOTE-859 China Extension study
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    KEYNOTE-859 study of pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Outcomes in the protocol-specified PD-L1–selected populations.

    Published date:
    05/31/2023
    Excerpt:
    Together with the efficacy and safety results from the ITT population, these data support pembro + chemo as a new first-line treatment option for pts with locally advanced or metastatic HER2-negative G/GEJ adenocarcinoma, regardless of PD-L1 expression.
    Secondary therapy:
    CF; CAPOX
    DOI:
    10.1200/JCO.2023.41.16_suppl.4014
    Trial ID:
    KEYNOTE-859