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Therapy Name | Abemaciclib + Temozolomide |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Abemaciclib | Verzenio | LY2835219 | CDK4/6 Inhibitor 14 | Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor as initial therapy for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov). |
Temozolomide | Temodar | Methazolastone|TMZ | Chemotherapy - Alkylating 18 | Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
CDKN2A del | glioblastoma | no benefit | Abemaciclib + Temozolomide | Phase II | Actionable | In a Phase II trial (INSIGhT), concurrent radiation and Temodar (temozolomide) followed by adjuvant Verzenio (abemaciclib) (n=73) improved progression-free survival (PFS; HR 0.72, p=0.046) but not overall survival (OS; HR 0.69, p=0.053) compared to standard chemoradiation (n=51) in newly-diagnosed MGMT-unmethylated glioblastoma patients, PFS (HR 0.69, p=0.053) and OS (HR 0.76, p=0.12) were not improved in the CDK biomarker-positive (CDK4/6 amp or CDKN2A deletion) subgroup (PMID: 37722087; NCT02977780). | 37722087 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02977780 | Phase II | CC-115 Abemaciclib + Temozolomide Temozolomide Neratinib + Temozolomide | INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) | Recruiting | USA | 0 |
NCT04238819 | Phase I | Abemaciclib + Temozolomide Abemaciclib + Irinotecan + Temozolomide | A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors | Active, not recruiting | USA | ITA | FRA | ESP | DEU | BEL | AUS | 1 |
NCT05413304 | Phase I | Abemaciclib + Temozolomide Abemaciclib | Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis | Recruiting | USA | 0 |
NCT06413706 | Phase II | Abemaciclib + Temozolomide Temozolomide | A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy | Not yet recruiting | USA | ROU | ITA | FRA | ESP | DNK | BEL | 1 |