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Therapy Name | Ceritinib + Ribociclib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Ceritinib | Zykadia | LDK378 | ALK Inhibitor 28 ROS1 Inhibitor 19 | 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 | CDK4/6 Inhibitor 11 | 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02780128 | Phase I | Siremadlin Ceritinib + Ribociclib Trametinib | Next Generation Personalized Neuroblastoma Therapy | Recruiting | USA | 0 |
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 |