United States-based AbbVie has failed to meet its goal in a phase three trial named DBL3001 for its Ibrutinib (IMBRUVICA) in untreated diffuse large B-cell lymphoma patients, it was reported yesterday.

The product is a first-in-class Bruton's tyrosine kinase inhibitor jointly developed and commercialised by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc (Janssen). It has been available in the United States since 2013 and is FDA-approved for use in five B-cell blood cancers and chronic graft-versus-host-disease for a total of eight FDA-approved indications.

The DBL3001 study assessed the addition of ibrutinib to a chemotherapy regimen that includes five different agents used in combination, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), versus R-CHOP plus placebo. The study was conducted in a subset of untreated DLBCL patients identified to have the non-germinal center B cell (GCB) or activated B-cell (ABC) subtypes of this disease. Patients identified with non-GCB or ABC subtypes typically have poorer treatment outcomes and have greater unmet medical need. At conclusion of the study, data collected found that ibrutinib plus the chemotherapy regimen, R-CHOP, was not superior to R-CHOP alone, and that the study did not meet its primary endpoint of improving event-free survival (EFS) in the targeted patient population.