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Therapy Name | Ibrutinib + Palbociclib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Ibrutinib | Imbruvica | PCI-32765 | BTK inhibitor 25 EGFR Inhibitor (Pan) 46 HER2 Inhibitor 26 | Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov). |
Palbociclib | Ibrance | PD0332991 | CDK4/6 Inhibitor 10 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
Unknown unknown | mantle cell lymphoma | not applicable | Ibrutinib + Palbociclib | Phase I | Actionable | In a Phase I trial, Imbruvica (ibrutinib) and Ibrance (palbociclib) combination treatment resulted in an overall response rate of 67%, a complete response rate of 37%, and a two year progression-free survival in 59.4% of patients with previously treated mantle cell lymphoma, with a median follow up of 25.6 months (PMID: 30692121; NCT02159755). | detail... 30692121 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03478514 | Phase II | Ibrutinib + Palbociclib | Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma | Recruiting | USA | 0 |
NCT02159755 | Phase I | Ibrutinib + Palbociclib | Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |