Data from Pharmawand - Curated by EPG Health - Date added 12 July 2018
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.