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    Association details:
    Biomarker:ALK rearrangement
    Cancer:Non Small Cell Lung Cancer
    Drug:Zykadia (ceritinib) (ALK inhibitor) +
    Kisqali (ribociclib) (CDK4 inhibitor, CDK6 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.

    Excerpt:
    ...The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test....
    Trial ID:
    NCT02292550
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lung Cancer
    Title:

    Phase Ib/II study of ceritinib in combination with ribociclib in patients with ALK-rearranged non-small cell lung cancer

    Published date:
    03/01/2022
    Excerpt:
    Among the 27 evaluable patients, the overall response rate (ORR) was 37.0% (95% CI, 19.4-57.6) and median progression-free survival (mPFS) was 21.5 months (95% CI, 5.5-25.0). At RP2D, the ORR was 50.0%, disease control rate was 75%, and mPFS was 24.8 months (95% CI, 5.5-25.1)....Combination of ceritinib and ribociclib showed clinical activity with a manageable safety profile in patients with advanced ALK-rearranged NSCLC.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lung Cancer
    Title:

    Phase Ib/II study of ceritinib in combination with ribociclib in patients with ALK-rearranged non–small cell lung cancer

    Published date:
    03/01/2022
    Excerpt:
    Twenty-seven adult patients with ALK–rearranged advanced NSCLC with an ECOG PS ≤2 were enrolled into five cohorts to receive various dose combinations of ceritinib (range, 300–450 mg/day) and ribociclib (range, 100–300 mg/day)...Among the 27 evaluable patients, the overall response rate (ORR) was 37.0% (95% CI, 19.4–57.6) and median progression-free survival (mPFS) was 21.5 months (95% CI, 5.5–25.0). At RP2D, the ORR was 50.0%, disease control rate was 75%, and mPFS was 24.8 months (95% CI, 5.5–25.1)....Combination of ceritinib and ribociclib showed clinical activity with a manageable safety profile in patients with advanced ALK-rearranged NSCLC.
    DOI:
    https://doi.org/10.1016/j.lungcan.2022.02.010