Therapy Detail

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Therapy Name Ceritinib + Ribociclib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ceritinib Zykadia LDK378 ALK Inhibitor 32 ROS1 Inhibitor 20 Zykadia (ceritinib) inhibits ALK, including ALK mutations and fusions, and has additional activity against ROS1 fusions, potentially resulting in decreased tumor cell growth (PMID: 25322323, PMID: 26372962). Zykadia (ceritinib) is FDA approved for ALK-positive (rearrangements and fusions) metastatic non-small cell lung cancer (FDA.gov).
Ribociclib Kisqali LEE011|LEE-011|LEE 011 CDK4/6 Inhibitor 13 Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK del exon2 ALK del exon3 ALK amp neuroblastoma sensitive Ceritinib + Ribociclib Preclinical - Cell culture Actionable In a preclinical study, the combination of Zykadia (ceritinib) and Kisqali (ribociclib) inhibited proliferation in a neuroblastoma cell line harboring a deletion of ALK exons 2 and 3 and ALK amplification in culture (PMID: 27986745). 27986745
ALK rearrange lung non-small cell carcinoma predicted - sensitive Ceritinib + Ribociclib Phase Ib/II Actionable In a Phase I/II trial, Zykadia (ceritinib) and Kisqali (ribociclib) combination therapy demonstrated a manageable safety profile and resulted in an overall response rate of 37.0% (10/27; 1 complete response and 9 partial responses) with a median progression-free survival of 21.5 months in patients with advanced ALK-rearranged non-small cell lung cancer (PMID: 35298959). 35298959
ALK R1275Q neuroblastoma sensitive Ceritinib + Ribociclib Preclinical - Cell culture Actionable In a preclinical study, the combination of Zykadia (ceritinib) and Kisqali (ribociclib) synergistically inhibited proliferation and Alk phosphorylation and induced cell cycle arrest in neuroblastoma cell lines harboring ALK R1275Q in culture (PMID: 27986745). 27986745
ALK F1174L neuroblastoma sensitive Ceritinib + Ribociclib Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Zykadia (ceritinib) and Kisqali (ribociclib) synergistically inhibited proliferation and Alk phosphorylation and induced cell cycle arrest in neuroblastoma cell line harboring ALK F1174L in culture, and induced complete tumor regression and increased event-free survival compared to either agent alone (P<0.0001) in a cell line xenograft model (PMID: 27986745). 27986745
ALK F1245C neuroblastoma sensitive Ceritinib + Ribociclib Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Zykadia (ceritinib) and Kisqali (ribociclib) inhibited proliferation in a neuroblastoma cell line harboring ALK F1245C in culture, and resulted in enhanced tumor growth inhibition compared to either Zykadia (ceritinib) or Kisqali (ribociclib) alone (P=0.04 and P<0.0001, respectively) and induced complete and sustained tumor regression in a patient-derived xenograft (PDX) model (PMID: 27986745). 27986745

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02292550 Phase Ib/II Ceritinib + Ribociclib Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. Completed USA | ITA | FRA | ESP 2
NCT02780128 Phase I Siremadlin Ceritinib + Ribociclib Trametinib Next Generation Personalized Neuroblastoma Therapy Terminated USA 0


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