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fulvestrant + abemaciclib + copanlisib
- Development stage
- Phase 1
- Lead developer
- Washington University School of Medicine
- Modality
- Small Molecules
- Administration
- Intramuscular, Oral, Intravenous
01
Overview
Fulvestrant + Abemaciclib + Copanlisib (FAC) is an investigational triplet combination therapy developed by Washington University School of Medicine for the treatment of hormone receptor-positive (HR+), HER2-negative metastatic breast cancer that has become resistant to endocrine therapy. The regimen consists of three small molecule targeted agents: fulvestrant, a selective estrogen receptor degrader (SERD) administered intramuscularly; abemaciclib, an oral CDK4/6 inhibitor; and copanlisib, an intravenous PI3K inhibitor with activity against α and δ isoforms. The rationale for this combination is that simultaneously blocking the estrogen receptor, CDK4/6, and PI3K pathways may overcome resistance mechanisms and provide greater efficacy than targeting these pathways individually. A Phase I clinical trial (NCT03939897) evaluated the safety and recommended Phase II dose, but the Phase II portion was removed in late 2023 following Bayer's voluntary withdrawal of the copanlisib NDA.
- Brand names
- Verzenio (abemaciclib)Aliqopa (copanlisib)Faslodex (fulvestrant)
- Other names
- Fulvestrant + Abemaciclib + Copanlisib
02
Targets
CDK4 (Cyclin-dependent kinase 4)CDK6 (Cyclin-dependent kinase 6)DYRK1A (Dual-specificity tyrosine-phosphorylation-regulated kinase 1A)ESR1 (ERα)HIPK3PIK3CA (Phosphoinositide 3-kinase alpha)PIK3CB (Phosphatidylinositol 3-kinase beta subunit)PIK3CD (Phosphatidylinositol 3-kinase delta)PIK3CG (Phosphatidylinositol 4,5-bisphosphate 3-kinase gamma)
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