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    Association details:
    Biomarker:PD-L1 expression
    Cancer:Clear Cell Renal Cell Carcinoma
    Drug:Opdivo (nivolumab) (PD1 inhibitor) +
    Yervoy (ipilimumab) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    Opdivo® (Nivolumab) Intravenous Infusion Approved for First–Line Treatment of Advanced or Recurrent Non-Small Cell Lung Cancer in Combination Therapy in Taiwan

    Excerpt:
    Ono Pharmaceutical Co., Ltd...announced that Ono Pharma Taiwan Co., Ltd. (“OPTW”), a Taiwanese subsidiary of ONO, received the approval of Opdivo® (nivolumab)...from the Taiwan Food and Drug Administration (TFDA) in Taiwan for additional indication of the first-line treatment of advanced or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations, in the following combination therapies:...Combination therapy with Opdivo and Yervoy* (tumors express PD-L1 ≧1%)...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

    Excerpt:
    ...Overall survival (OS)`Overall response rate (ORR) by investigator`Disease control rate (DCR) by investigator`Duration of response (DoR) by investigator`Time to objective response (TTR) by investigator`Progression Free Survival (PFS) by investigator`Progression free survival secondary objective (PFS2) by investigator`Disease control rate (DCR) by BICR`Duration of response (DoR) by BICR`Time to objective response (TTR) by BICR`Incidence of Adverse Events (AEs)`Incidence of drug-related AEs`Incidence of Severe Adverse Events (SAEs)`Incidence of drug-related SAEs`Incidence of clinically significant changes in clinical laboratory results: Hematology tests`Incidence of clinically significant changes in clinical laboratory results: Coagulation tests`Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests`Incidence of clinically significant changes in clinical laboratory results: Serology tests`PFS based on gene expression (GEP) signatures`Objective response rate (ORR) based on GEP signatures`OS based on GEP signatures`OS based on programmed cell death protein ligand-1 (PD-L1) expression`ORR by BICR based on PD-L1 expression`PFS by BICR based on PD-L1 expression...
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO-GU 2022
    Title:

    Novel predictive biomarkers of response to immune checkpoint blockade with nivolumab ± ipilimumab in the TITAN-RCC phase 2 trial.

    Published date:
    02/14/2022
    Excerpt:
    To identify novel predictive biomarkers, we explored the characteristics of blood-circulating immune cell subsets within the population of the TITAN-RCC trial (NCT02917772)...in patients receiving nivo+ipi “boosts”, a higher proportion of PD-L1+ CD14+ monocytes (ORadj 1.22, 95% CI 1.06-1.58), PD-L1+ early-stage MDSC (ORadj 1.14, 95% CI 1.02-1.41) and PD-L1+ plasmacytoid DC (ORadj 1.08, 95% CI 1.01-1.17) was observed in responders compared to non-responders.
    DOI:
    10.1200/JCO.2022.40.6_suppl.367
    Trial ID:
    TITAN-RCC