Imbruvica

Drug Overview
Imbruvica (ibrutinib; AbbVie/Johnson & Johnson) is an oral small molecule inhibitor of Bruton’s tyrosine kinase (BTK). BTK is part of the B-cell receptor signaling pathway, which promotes cell proliferation, adhesion, and survival in many B-cell malignancies. Imbruvica has been shown to inhibit these actions and induce apoptosis in malignant B-cells in preclinical models.

Analyst Outlook
Imbruvica (ibrutinib; AbbVie/Johnson & Johnson) is not expected to receive approval for the treatment of diffuse large B-cell lymphoma (DLBCL) after failing to meet the primary endpoint of improved progression-free survival (PFS) in the Phase III PHOENIX trial (ClinicalTrials.gov identifier: NCT01855750) for non-germinal center B-cell (GCB) DLBCL patients. However, AbbVie and Johnson & Johnson indicate that efficacy was seen in an unspecified subpopulation of patients, signaling that future development in this indication is possible. Potential approval, even in a small subgroup within the non-GCB subtype, would help to fill an unmet need as these patients typically have a worse prognosis and do not respond well to standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy. However, Imbruvica’s outlook will remain poor in DLBCL without clarity on the targeted patient subgroup or data to confirm efficacy.