A phase 3 trial designed to evaluate the addition of ibrutinib to standard chemotherapy for the treatment of newly diagnosed nongerminal center B-cell diffuse large B-cell lymphoma failed to meet its primary endpoint, according to the agent’s manufacturer.
Ibrutinib (Imbruvica; Pharmacyclics, Janssen), a first-in-class Bruton’s tyrosine kinase inhibitor, already is approved for several indications. They include treatment of certain adults with mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia, marginal zone lymphoma and chronic graft-versus-host disease.
The double-blind, placebo-controlled PHOENIX trial assessed the efficacy and safety of ibrutinib in combination with R-CHOP — which consists of rituximab (Rituxan; Genentech, Biogen), cyclophosphamide, doxorubicin, vincristine and prednisone — for patients with newly diagnosed nongerminal center B-cell DLBCL, an aggressive form of non-Hodgkin lymphoma.
R-CHOP is the standard treatment for DLBCL.
Researchers randomly assigned patients 1:1 to R-CHOP plus 560 mg ibrutinib or R-CHOP plus placebo.
The trial failed to show a statistically significant benefit in EFS — the study’s primary endpoint — among ibrutinib-treated patients.
“[Although] we are disappointed that the overall study did not result in the outcome that we had hoped for in patients living with DLBCL, we are conducting additional analyses to further understand potential benefits we have observed in a subpopulation of patients,” Craig Tendler, MD, vice president for clinical development and global medical affairs at Janssen Research & Development LLC, said in a press release. “These analyses will be informative in preparation for upcoming consultations with health authorities. We look forward to these regulatory discussions and to submitting the PHOENIX data for presentation at a major medical conference later this year.”