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CM067 WES - Clinical Outcomes by Tumor Mutational Burden and Inflammatory Gene Expression With Combined Nivolumab and Ipilimumab or Monotherapy in Advanced Melanoma

Purpose Exploratory analyses of CheckMate 066 and 067 trials were conducted to investigate associations of tumor mutational burden (TMB), a 4-gene inflammatory gene expression signature, and BRAF mutation status with tumor response, progression-free survival (PFS), and overall survival (OS) in patients with advanced melanoma. Patients and Methods Patients with known programmed death ligand 1 (PD-L1) expression and BRAF mutation status received nivolumab (NIVO) or dacarbazine in CheckMate 066 and either NIVO, ipilimumab (IPI), or NIVO+IPI in CheckMate 067. Whole exome sequencing and RNA sequencing were used to determine TMB and inflammatory gene expression signature scores, respectively. These biomarkers were evaluated in terms of their association with PFS and OS. Results In the NIVO, NIVO+IPI, and IPI arms of CheckMate 067, longer survival was associated with high (> median) versus low (≤ median) TMB with hazard ratios (HRs) (95% confidence interval [CI]) for PFS of 0.45 (0.30–0.65), 0.55 (0.38–0.81), and 0.60 (0.43–0.82), and for OS of 0.46 (0.30–0.71), 0.53 (0.34–0.82), and 0.52 (0.36–0.74), respectively. For NIVO-treated patients, these results were confirmed in CheckMate 066. A survival benefit was observed with high TMB and absence of BRAF mutation. Survival was associated with high versus low inflammatory signature scores with HRs (95% CI) for PFS of 0.56 (0.34–0.94), 0.40 (0.23–0.72), and 0.43 (0.27–0.70), and for OS of 0.37 (0.20–0.66), 0.38 (0.19–0.74), and 0.46 (0.27–0.79), in the NIVO, NIVO+IPI, and IPI arms, respectively. Weak correlations were observed between PD-L1, TMB, and the inflammatory signature. Conclusions Combined assessment of TMB, inflammatory gene expression signature, and BRAF mutation status may be predictive for response to immunotherapy in advanced melanoma.

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Studies are experimental investigations of a particular phenomenon, e.g., case-control studies on a particular trait or cancer research projects reporting matching cancer normal genomes from patients.

Study ID Study Title Study Type
EGAS00001004555 Other

This table displays only public information pertaining to the files in the dataset. If you wish to access this dataset, please submit a request. If you already have access to these data files, please consult the download documentation.

ID File Type Size Located in
EGAF00005207785 fastq.gz 3.7 GB
EGAF00005207786 fastq.gz 3.8 GB
EGAF00005207787 fastq.gz 4.3 GB
EGAF00005207788 fastq.gz 4.6 GB
EGAF00005207789 fastq.gz 3.9 GB
EGAF00005207790 fastq.gz 4.1 GB
EGAF00005207791 fastq.gz 3.9 GB
EGAF00005207792 fastq.gz 4.2 GB
EGAF00005207793 fastq.gz 5.0 GB
EGAF00005207794 fastq.gz 5.3 GB
EGAF00005207795 fastq.gz 3.4 GB
EGAF00005207796 fastq.gz 3.5 GB
EGAF00005207797 fastq.gz 4.0 GB
EGAF00005207798 fastq.gz 4.1 GB
EGAF00005207799 fastq.gz 3.7 GB
EGAF00005207800 fastq.gz 3.8 GB
EGAF00005207801 fastq.gz 4.1 GB
EGAF00005207802 fastq.gz 4.0 GB
EGAF00005207803 fastq.gz 4.1 GB
EGAF00005207804 fastq.gz 4.3 GB
EGAF00005207805 fastq.gz 3.5 GB
EGAF00005207806 fastq.gz 3.5 GB
EGAF00005207807 fastq.gz 3.9 GB
EGAF00005207808 fastq.gz 3.8 GB
EGAF00005207809 fastq.gz 4.2 GB
EGAF00005207810 fastq.gz 4.1 GB
EGAF00005207811 fastq.gz 4.0 GB
EGAF00005207812 fastq.gz 4.0 GB
EGAF00005207813 fastq.gz 4.2 GB
EGAF00005207814 fastq.gz 4.4 GB
EGAF00005207815 fastq.gz 4.3 GB
EGAF00005207816 fastq.gz 4.4 GB
EGAF00005207817 fastq.gz 3.9 GB
EGAF00005207818 fastq.gz 4.2 GB
EGAF00005207819 fastq.gz 3.5 GB
EGAF00005207820 fastq.gz 3.7 GB
EGAF00005207821 fastq.gz 4.4 GB
EGAF00005207822 fastq.gz 4.8 GB
EGAF00005207823 fastq.gz 4.4 GB
EGAF00005207824 fastq.gz 4.7 GB
EGAF00005207825 fastq.gz 4.1 GB
EGAF00005207826 fastq.gz 4.3 GB
EGAF00005207827 fastq.gz 3.7 GB
EGAF00005207828 fastq.gz 3.7 GB
EGAF00005207829 fastq.gz 4.3 GB
EGAF00005207830 fastq.gz 4.5 GB
EGAF00005207831 fastq.gz 3.7 GB
EGAF00005207832 fastq.gz 3.9 GB
EGAF00005207833 fastq.gz 4.3 GB
EGAF00005207834 fastq.gz 4.4 GB
EGAF00005207835 fastq.gz 4.0 GB
EGAF00005207836 fastq.gz 4.0 GB
EGAF00005207837 fastq.gz 4.1 GB
EGAF00005207838 fastq.gz 4.5 GB
EGAF00005207839 fastq.gz 4.4 GB
EGAF00005207840 fastq.gz 4.6 GB
EGAF00005207841 fastq.gz 4.2 GB
EGAF00005207842 fastq.gz 4.3 GB
EGAF00005207843 fastq.gz 4.0 GB
EGAF00005207844 fastq.gz 4.1 GB
EGAF00005207845 fastq.gz 3.7 GB
EGAF00005207846 fastq.gz 3.9 GB
EGAF00005207847 fastq.gz 3.8 GB
EGAF00005207848 fastq.gz 3.9 GB
EGAF00005207849 fastq.gz 3.6 GB
EGAF00005207850 fastq.gz 3.6 GB
EGAF00005207851 fastq.gz 3.6 GB
EGAF00005207852 fastq.gz 3.8 GB
EGAF00005207853 fastq.gz 3.7 GB
EGAF00005207854 fastq.gz 3.9 GB
EGAF00005207855 fastq.gz 3.9 GB
EGAF00005207856 fastq.gz 4.1 GB
EGAF00005207857 fastq.gz 3.7 GB
EGAF00005207858 fastq.gz 4.0 GB
EGAF00005207859 fastq.gz 3.2 GB
EGAF00005207860 fastq.gz 3.3 GB
EGAF00005207861 fastq.gz 3.5 GB
EGAF00005207862 fastq.gz 3.8 GB
EGAF00005207863 fastq.gz 4.3 GB
EGAF00005207864 fastq.gz 4.5 GB
EGAF00005207865 fastq.gz 3.8 GB
EGAF00005207866 fastq.gz 4.1 GB
EGAF00005207867 fastq.gz 4.6 GB
EGAF00005207868 fastq.gz 4.9 GB
EGAF00005207869 fastq.gz 4.3 GB
EGAF00005207870 fastq.gz 4.5 GB
EGAF00005207871 fastq.gz 3.4 GB
EGAF00005207872 fastq.gz 3.6 GB
EGAF00005207873 fastq.gz 3.7 GB
EGAF00005207874 fastq.gz 4.0 GB
EGAF00005207875 fastq.gz 3.1 GB
EGAF00005207876 fastq.gz 3.3 GB
EGAF00005207877 fastq.gz 4.6 GB
EGAF00005207878 fastq.gz 4.8 GB
EGAF00005207879 fastq.gz 3.2 GB
EGAF00005207880 fastq.gz 3.3 GB
EGAF00005207881 fastq.gz 3.2 GB
EGAF00005207882 fastq.gz 3.5 GB
EGAF00005207883 fastq.gz 3.7 GB
EGAF00005207884 fastq.gz 3.8 GB
EGAF00005207885 fastq.gz 3.3 GB
EGAF00005207886 fastq.gz 3.3 GB
EGAF00005207887 fastq.gz 3.2 GB
EGAF00005207888 fastq.gz 3.4 GB
EGAF00005207889 fastq.gz 3.1 GB
EGAF00005207890 fastq.gz 3.2 GB
EGAF00005207891 fastq.gz 3.3 GB
EGAF00005207892 fastq.gz 3.5 GB
EGAF00005207893 fastq.gz 4.0 GB
EGAF00005207894 fastq.gz 4.2 GB
EGAF00005207895 fastq.gz 4.7 GB
EGAF00005207896 fastq.gz 5.0 GB
EGAF00005207897 fastq.gz 4.3 GB
EGAF00005207898 fastq.gz 4.6 GB
EGAF00005207899 fastq.gz 4.6 GB
EGAF00005207900 fastq.gz 4.9 GB
EGAF00005207901 fastq.gz 3.6 GB
EGAF00005207902 fastq.gz 3.8 GB
EGAF00005207903 fastq.gz 3.5 GB
EGAF00005207904 fastq.gz 3.7 GB
EGAF00005207905 fastq.gz 4.4 GB
EGAF00005207906 fastq.gz 4.8 GB
EGAF00005207907 fastq.gz 3.5 GB
EGAF00005207908 fastq.gz 3.7 GB
EGAF00005207909 fastq.gz 4.7 GB
EGAF00005207910 fastq.gz 4.9 GB
EGAF00005207911 fastq.gz 4.4 GB
EGAF00005207912 fastq.gz 4.8 GB
EGAF00005207913 fastq.gz 4.0 GB
EGAF00005207914 fastq.gz 3.9 GB
EGAF00005207915 fastq.gz 4.2 GB
EGAF00005207916 fastq.gz 4.6 GB
EGAF00005207917 fastq.gz 4.2 GB
EGAF00005207918 fastq.gz 4.5 GB
EGAF00005207919 fastq.gz 4.0 GB
EGAF00005207920 fastq.gz 4.4 GB
EGAF00005207921 fastq.gz 4.0 GB
EGAF00005207922 fastq.gz 4.4 GB
EGAF00005207923 fastq.gz 4.2 GB
EGAF00005207924 fastq.gz 4.5 GB
EGAF00005207925 fastq.gz 4.0 GB
EGAF00005207926 fastq.gz 4.2 GB
EGAF00005207927 fastq.gz 4.0 GB
EGAF00005207928 fastq.gz 4.2 GB
EGAF00005207929 fastq.gz 4.4 GB
EGAF00005207930 fastq.gz 4.3 GB
EGAF00005207931 fastq.gz 3.8 GB
EGAF00005207932 fastq.gz 4.0 GB
EGAF00005207933 fastq.gz 3.5 GB
EGAF00005207934 fastq.gz 3.7 GB
EGAF00005207935 fastq.gz 4.1 GB
EGAF00005207936 fastq.gz 4.0 GB
EGAF00005207937 fastq.gz 4.1 GB
EGAF00005207938 fastq.gz 4.3 GB
EGAF00005207939 fastq.gz 3.6 GB
EGAF00005207940 fastq.gz 3.7 GB
EGAF00005207941 fastq.gz 4.1 GB
EGAF00005207942 fastq.gz 4.4 GB
EGAF00005207943 fastq.gz 3.8 GB
EGAF00005207944 fastq.gz 3.8 GB
EGAF00005207945 fastq.gz 4.4 GB
EGAF00005207946 fastq.gz 4.3 GB
EGAF00005207947 fastq.gz 4.0 GB
EGAF00005207948 fastq.gz 4.1 GB
EGAF00005207949 fastq.gz 3.7 GB
EGAF00005207950 fastq.gz 3.9 GB
EGAF00005207951 fastq.gz 3.3 GB
EGAF00005207952 fastq.gz 3.6 GB
EGAF00005207953 fastq.gz 3.6 GB
EGAF00005207954 fastq.gz 3.7 GB
EGAF00005207955 fastq.gz 4.5 GB
EGAF00005207956 fastq.gz 4.7 GB
EGAF00005207957 fastq.gz 5.3 GB
EGAF00005207958 fastq.gz 5.6 GB
EGAF00005207959 fastq.gz 4.2 GB
EGAF00005207960 fastq.gz 4.1 GB
EGAF00005207961 fastq.gz 4.5 GB
EGAF00005207962 fastq.gz 4.7 GB
EGAF00005207963 fastq.gz 3.9 GB
EGAF00005207964 fastq.gz 4.3 GB
EGAF00005207965 fastq.gz 4.0 GB
EGAF00005207966 fastq.gz 4.2 GB
EGAF00005207967 fastq.gz 3.7 GB
EGAF00005207968 fastq.gz 3.6 GB
EGAF00005207969 fastq.gz 3.5 GB
EGAF00005207970 fastq.gz 3.7 GB
EGAF00005207971 fastq.gz 4.4 GB
EGAF00005207972 fastq.gz 4.8 GB
EGAF00005207973 fastq.gz 3.8 GB
EGAF00005207974 fastq.gz 4.0 GB
EGAF00005207975 fastq.gz 4.5 GB
EGAF00005207976 fastq.gz 4.7 GB
EGAF00005207977 fastq.gz 3.7 GB
EGAF00005207978 fastq.gz 3.7 GB
EGAF00005207979 fastq.gz 3.6 GB
EGAF00005207980 fastq.gz 3.7 GB
EGAF00005207981 fastq.gz 4.3 GB
EGAF00005207982 fastq.gz 4.4 GB
EGAF00005207983 fastq.gz 4.0 GB
EGAF00005207984 fastq.gz 4.2 GB
EGAF00005207985 fastq.gz 4.3 GB
EGAF00005207986 fastq.gz 4.5 GB
EGAF00005207987 fastq.gz 3.8 GB
EGAF00005207988 fastq.gz 3.9 GB
EGAF00005207989 fastq.gz 3.5 GB
EGAF00005207990 fastq.gz 3.6 GB
EGAF00005207991 fastq.gz 4.1 GB
EGAF00005207992 fastq.gz 4.2 GB
EGAF00005207993 fastq.gz 4.2 GB
EGAF00005207994 fastq.gz 4.4 GB
EGAF00005207995 fastq.gz 3.7 GB
EGAF00005207996 fastq.gz 3.9 GB
EGAF00005207997 fastq.gz 4.1 GB
EGAF00005207998 fastq.gz 4.2 GB
EGAF00005207999 fastq.gz 4.1 GB
EGAF00005208000 fastq.gz 4.3 GB
EGAF00005208001 fastq.gz 4.1 GB
EGAF00005208002 fastq.gz 4.3 GB
EGAF00005208003 fastq.gz 3.5 GB
EGAF00005208004 fastq.gz 3.6 GB
EGAF00005208005 fastq.gz 3.9 GB
EGAF00005208006 fastq.gz 4.0 GB
EGAF00005208007 fastq.gz 4.5 GB
EGAF00005208008 fastq.gz 4.7 GB
EGAF00005208009 fastq.gz 4.2 GB
EGAF00005208010 fastq.gz 4.5 GB
EGAF00005208011 fastq.gz 3.6 GB
EGAF00005208012 fastq.gz 3.7 GB
EGAF00005208013 fastq.gz 3.3 GB
EGAF00005208014 fastq.gz 3.4 GB
EGAF00005208015 fastq.gz 3.7 GB
EGAF00005208016 fastq.gz 3.8 GB
EGAF00005208017 fastq.gz 3.6 GB
EGAF00005208018 fastq.gz 3.8 GB
EGAF00005208019 fastq.gz 5.0 GB
EGAF00005208020 fastq.gz 5.4 GB
EGAF00005208021 fastq.gz 3.4 GB
EGAF00005208022 fastq.gz 3.5 GB
EGAF00005208023 fastq.gz 3.7 GB
EGAF00005208024 fastq.gz 3.8 GB
EGAF00005208025 fastq.gz 3.7 GB
EGAF00005208026 fastq.gz 3.9 GB
EGAF00005208027 fastq.gz 4.6 GB
EGAF00005208028 fastq.gz 4.7 GB
244 Files (985.1 GB)