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    Association details:
    Biomarker:No biomarker
    Cancer:Malignant Pleural Mesothelioma
    Drug:Opdivo (nivolumab) (PD1 inhibitor) +
    Yervoy (ipilimumab) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    Health Canada Approves OPDIVO (nivolumab) plus YERVOY (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

    Published date:
    06/02/2021
    Excerpt:
    Today, Bristol Myers Squibb Canada (BMS) announced Health Canada’s approval of OPDIVO (nivolumab) 360 mg every three weeks or 3mg/kg every two weeks plus YERVOY (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.
    Trial ID:
    CheckMate 743
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma

    Published date:
    06/02/2021
    Excerpt:
    Bristol Myers Squibb...announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
    Trial ID:
    CheckMate 743
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    12/29/2020
    Excerpt:
    OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of…adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Excerpt:
    ...the NCCN panel recommends the following subsequent immunotherapy options for patients with MPM:…2) nivolumab with (or without) ipilimumab…
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    ESMO.org
    Title:

    Malignant pleural mesothelioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

    Excerpt:
    Recommendations...First-line systemic therapy...Nivolumab plus ipilimumab, given up to 2 years equivalent dosing, is recommended as a first-line systemic therapy option regardless of histologies or PD-L1 status for unresectable MPM [I, A; ESMO-MCBS v1.1 score: 3]
    DOI:
    https://doi.org/10.1016/j.annonc.2021.11.005
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Ann Oncol
    Title:

    First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743

    Published date:
    02/02/2022
    Excerpt:
    ...nivolumab plus ipilimumab continued to prolong OS versus chemotherapy. Median OS was 18.1 versus 14.1 months (HR [95% CI], 0.73 [0.61–0.87]), and 3-year OS rates were 23% versus 15%, respectively. Three-year progression-free survival rates were 14% versus 1%, and objective response rates were 40% versus 44%. At 3 years, 28% versus 0% of responders had an ongoing response. Improved survival benefit with nivolumab plus ipilimumab versus chemotherapy was observed across subgroups...
    DOI:
    https://www.annalsofoncology.org/article/S0923-7534(22)00083-7/fulltext
    Trial ID:
    CheckMate 743
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma

    Published date:
    04/23/2021
    Excerpt:
    Bristol Myers Squibb...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM)...The positive CHMP opinion is based on results from CheckMate -743, the first and only positive Phase 3 immunotherapy trial in first-line MPM. The trial met the primary endpoint of superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients.
    Secondary therapy:
    pemetrexed + carboplatin; cisplatin + pemetrexed
    Trial ID:
    CheckMate 743
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet
    Title:

    First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial

    Published date:
    01/21/2021
    Excerpt:
    At the prespecified interim analysis...nivolumab plus ipilimumab significantly extended overall survival versus chemotherapy...2-year overall survival rates were 41% (95% CI 35·1–46·5) in the nivolumab plus ipilimumab group and 27% (21·9–32·4) in the chemotherapy group....Nivolumab plus ipilimumab provided significant and clinically meaningful improvements in overall survival versus standard-of-care chemotherapy...
    DOI:
    https://doi.org/10.1016/S0140-6736(20)32714-8
    Trial ID:
    CheckMate 743