Therapy Detail

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Therapy Name Abemaciclib + Temozolomide
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Abemaciclib Verzenio LY2835219 CDK4/6 Inhibitor 13 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).

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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

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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
NCT05413304 Phase I Abemaciclib + Temozolomide Abemaciclib Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis 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 Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS 0


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