acalabrutinib + ACP-319

Acalabrutinib + ACP-319 is a combination of two small molecule kinase inhibitors that target distinct signaling nodes within malignant B cells. **Acalabrutinib** is a second-generation Bruton's tyrosine kinase (BTK) inhibitor, approved for use as an anti-cancer agent in diseases such as mantle cell lymphoma and chronic lymphocytic leukemia. **ACP-319** (also known as ACP319) is an investigational phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor developed for B-cell malignancies. Preclinical studies and early clinical trials have evaluated the combination for enhanced anti-tumor efficacy, demonstrating that simultaneous inhibition of BTK and PI3Kδ leads to superior tumor control and survival, particularly in chronic lymphocytic leukemia models, compared to either agent alone. The rationale is based on the partially redundant roles of BTK and PI3Kδ in B-cell receptor (BCR) signaling, microenvironment interactions, and survival pathways such as NF-κB signaling.

Brand names

Calquence