Drug intelligence / Profile preview

alpelisib + nab-paclitaxel

Development stage
Phase 2
Lead developer
Novartis
Modality
Small Molecules, Nanoparticles → Drug Delivery Systems
Administration
Oral, Intravenous
01

Overview

Alpelisib + nab-paclitaxel is a combination therapy under investigation for the treatment of HER2-negative metastatic breast cancer, including triple-negative subtypes. Alpelisib is an oral, selective inhibitor of the phosphatidylinositol 3-kinase catalytic subunit alpha (PI3Kα), targeting tumors with PIK3CA mutations or PTEN loss. Nab-paclitaxel is a nanoparticle albumin-bound formulation of paclitaxel, a microtubule inhibitor that disrupts cell division. The combination aims to overcome resistance mechanisms in breast cancer by simultaneously inhibiting PI3K signaling and disrupting mitosis. Clinical studies have shown this regimen to be well-tolerated with encouraging efficacy, particularly in patients harboring PIK3CA mutations[1][2][5]. The combination is being evaluated in phase II and III clinical trials for advanced/metastatic HER2-negative breast cancer[4][5].

Other names
alpelisib and nab-paclitaxelBYL719 and ABI-007BYL-719 and ABI-007BYL 719 and ABI-007
02

Targets

TUBB (Tubulin (alpha and beta subunits))PIK3CA (Phosphoinositide 3-kinase alpha)

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