Published 12 July 2018
AbbVie’s Ibrutinib (IMBRUVICA) failed to meet its objective in a phase 3 trial DBL3001 in untreated diffuse large B-cell lymphoma (DLBCL) patients.
IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. (Janssen).
IMBRUVICA has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as in chronic graft-versus-host-disease for a total of eight FDA-approved indications.
The DBL3001 study evaluated the addition of ibrutinib to a chemotherapy regimen consisting of five different agents used in combination – rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) – versus R-CHOP plus placebo.
R-CHOP is the current standard of care in newly diagnosed DLBCL patients and provided as a first-line therapy for most patients today.
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.
However, clinically meaningful improvements were observed in a patient sub-population that warrant further analysis. Full results from this study will be presented at an upcoming scientific conference and published in a peer-reviewed medical journal.
AbbVie Pharmacyclics clinical development head Thorsten Graef said: “Since its first U.S. FDA approval in 2013, IMBRUVICA has redefined standard of care in many different blood cancers – several of which had little to no treatment options available to patients before.
“These medical achievements reflect our objective of focusing research where there is great unmet patient need and understanding that the nature of research is such that some studies succeed and others do not. We continue to believe that ibrutinib has great untapped potential as a cancer treatment alone or in combination.
“Together with our global partner Janssen, we are advancing our robust ibrutinib scientific development program and anticipate results from several studies in the future.”
Source: Company Press Release