Phase III PHOENIX trial of Imbruvica + R-CHOP fails to meet primary endpoint in non-Germinal Center B cell subtype of DLBCL.- Janssen.

Janssen Pharmaceutical announced topline results from the Phase III PHOENIX trial evaluating the investigational use of Imbruvica (ibrutinib) plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in the treatment of newly diagnosed non-Germinal Center B cell (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL). The study compared Imbruvica plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) versus R-CHOP, the current standard of care in DLBCL. The clinical trial did not meet the primary endpoint of event-free survival in patients with non-GCB subtype of DLBCL, including activated B cell-like (ABC) subtype of DLBCL. Janssen is conducting further analyses of the PHOENIX study results to assess the potential efficacy of Imbruvica as observed in a patient sub-population.

In the study, patients were randomized in a 1:1 ratio to receive either placebo plus R-CHOP or 560 mg ibrutinib plus R-CHOP stratified by Revised International Prognostic Index, geographic region, and number of pre-specified treatment cycles (6 vs. 8 cycles). The primary endpoint was event-free survival, defined as the time interval from randomization to the date of disease progression, relapse from complete response as assessed by the investigator, initiation of systemic anti-lymphoma therapy for either positron emission tomography-positive or biopsy-proven residual disease upon completion of at least 6 cycles of R-CHOP therapy, or death, whichever occurred first.