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    Association details:
    Biomarker:No biomarker
    Cancer:Hepatocellular Cancer
    Drug:Imfinzi (durvalumab) (PD-L1 inhibitor) +
    Imjudo (tremelimumab-actl) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Imfinzi plus Imjudo approved in the EU for patients with advanced liver and non-small cell lung cancers

    Published date:
    02/22/2023
    Excerpt:
    AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers….The approvals authorise Imfinzi in combination with Imjudo for the 1st-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC)...
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers

    Published date:
    12/28/2022
    Excerpt:
    AstraZeneca’s immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types: advanced liver, biliary tract and lung….The approvals authorise Imfinzi in combination with Imjudo for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of adult patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in combination with chemotherapy. Imfinzi was also authorised for the treatment of adult patients with unresectable HCC as monotherapy and for the treatment of adult patients with curatively unresectable biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    10/28/2022
    Excerpt:
    IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer

    Published date:
    10/24/2022
    Excerpt:
    AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    12/09/2022
    Excerpt:
    Hepatocellular Carcinoma...First-Line Systemic Therapy...Tremelimumab-actl + durvalumab (category 1)...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    AstraZeneca Press Release
    Title:

    Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers

    Published date:
    12/19/2022
    Excerpt:
    AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combinations have been recommended for marketing authorisation in the European Union (EU) for advanced liver and lung cancers….The concurrent positive opinions recommend authorising Imfinzi in combination with Imjudo for 1st-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC)...The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinions on results from the HIMALAYA Phase III trial...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    NEJM Evidence
    Title:

    Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma

    Published date:
    06/06/2022
    Excerpt:
    In this global, open-label, phase 3 trial, the majority of the patients we enrolled with unresectable hepatocellular carcinoma and no previous systemic treatment were randomly assigned to receive one of three regimens: tremelimumab (300 mg, one dose) plus durvalumab (1500 mg every 4 weeks; STRIDE), durvalumab (1500 mg every 4 weeks), or sorafenib (400 mg twice daily)....Overall survival at 36 months was 30.7%, 24.7%, and 20.2%, respectively....STRIDE significantly improved overall survival versus sorafenib.
    DOI:
    https://doi.org/10.1056/EVIDoa2100070
    Trial ID:
    HIMALAYA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2022
    Title:

    Patient-reported outcomes from the phase 3 HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.

    Published date:
    05/26/2022
    Excerpt:
    The positive OS outcomes for STRIDE and D in pts receiving first-line treatment for uHCC in HIMALAYA were associated with clinically meaningful, pt-centered benefits, demonstrated by delayed worsening of disease-related symptoms, PF, and GHS/QoL vs S. Median TTD in months (95% CI) in PROs for STRIDE and D vs S. Clinical trial information
    DOI:
    10.1200/JCO.2022.40.16_suppl.4074
    Trial ID:
    HIMALAYA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    AstraZeneca Press Release
    Title:

    Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi

    Published date:
    04/25/2022
    Excerpt:
    AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). A supplemental BLA (sBLA) has also been submitted for Imfinzi in this indication. This novel dose and schedule of the combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).