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    Association details:
    Biomarker:No biomarker
    Cancer:Hepatocellular Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    ASCO.org
    Title:

    Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline

    Published date:
    11/16/2020
    Excerpt:
    Recommendations…Second-Line Therapy…pembrolizumab or nivolumab are reasonable options that may be considered for appropriate candidates…
    DOI:
    0.1200/JCO.20.02672 Journal of Clinical Oncology
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Title:

    Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†

    Excerpt:
    Immunotherapies...Immunotherapy with nivolumab and pembrolizumab can be considered in patients who are intolerant to, or have progressed under, approved tyrosine kinase inhibitors, pending EMA approval [III, B].
    DOI:
    10.1093/annonc/mdy308
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Hepatocellular Cancer: First-line systemic therapy...Other Recommended Regimens…Pembrolizumab (category 2B)
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO-GI 2022
    Title:

    Pembrolizumab plus best supportive care versus placebo plus best supportive care as second-line therapy in patients in Asia with advanced hepatocellular carcinoma (HCC): Phase 3 KEYNOTE-394 study.

    Published date:
    01/18/2022
    Excerpt:
    The pembro safety profile was as expected. Overall, results were consistent with those previously observed in KEYNOTE-224 and KEYNOTE-240 and thus add to the body of evidence supporting the use of pembro as second-line therapy for advanced HCC.
    DOI:
    10.1200/JCO.2022.40.4_suppl.383
    Trial ID:
    KEYNOTE-394
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Merck (MSD) Press Release
    Title:

    Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo in Certain Patients With Advanced Hepatocellular Carcinoma (HCC) Previously Treated With Sorafenib

    Published date:
    01/18/2022
    Excerpt:
    Merck...announced the final results from the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA...KEYNOTE-394 is the first trial with an anti-PD-1/L1 as a second-line monotherapy treatment to show an improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo plus BSC for these patients.
    Trial ID:
    KEYNOTE-394
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Merck (MSD) Press Release
    Title:

    Merck Announces KEYTRUDA® (pembrolizumab) Met Primary Endpoint of Overall Survival (OS) in Patients with Advanced Hepatocellular Carcinoma Previously Treated with Sorafenib

    Published date:
    09/27/2021
    Excerpt:
    The study found that treatment with KEYTRUDA plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive care. KEYNOTE-394 also met its key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR), with statistically significant improvements for KEYTRUDA compared with placebo.
    Trial ID:
    KEYNOTE-394