Therapy Detail
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| Therapy Name | Palbociclib + Taselisib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 13 | 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). |
| Taselisib | RG7606|GDC-0032|RG-7604|RO5537381 | PIK3CA inhibitor 23 PIK3CD inhibitor 27 PIK3CG inhibitor 10 | Taselisib (GDC-0032) is a beta isoform-sparing PI3K inhibitor, with greater activity against oncogenic mutants of PIK3CA (PMID: 23662903, PMID: 31439579). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA act mut | Advanced Solid Tumor | predicted - sensitive | Palbociclib + Taselisib | Phase I | Actionable | In a Phase Ib trial (PIPA), the combination of Ibrance (palbociclib) with Taselisib (GDC-0032) was well tolerated in patients with advanced solid tumors harboring PIK3CA activating mutations and resulted in an objective response rate of 0% (0/12), a clinical benefit rate of 16.7% (2/12), and a median progression-free survival of 3.8 months (PMID: 32958578; NCT02389842). | 32958578 |
| PIK3CA act mut | estrogen-receptor positive breast cancer | predicted - sensitive | Palbociclib + Taselisib | Phase I | Actionable | In a Phase Ib trial (PIPA), the combination of Ibrance (palbociclib) with Taselisib (GDC-0032) was well tolerated in estrogen-receptor negative breast cancer patients harboring PIK3CA activating mutations and resulted in an objective response rate of 10% (1/10), a clinical benefit rate of 30% (4/10), and a median progression-free survival of 3.6 months (PMID: 32958578; NCT02389842). | 32958578 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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