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.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Biosimilars in Oncology Knowledge Centre

Biosimilars in Oncology Knowledge Centre

What are biologics and how do they differ from small molecule medicines? Discover more about their development, as well as the manufacturing and regulatory processes in the Biosimilars in Oncology Knowledge Centre.

Breakthrough Cancer Pain Learning Zone

Breakthrough Cancer Pain Learning Zone

Watch video highlights from the BeCOn OWN 2017 event, including expert opinion, patient experience and panel discussions in the Breakthrough Cancer Pain Learning Zone.

Load more

Related Content