The Janssen Pharmaceutical Companies of Johnson & Johnson announced topline results from the Phase 3 PHOENIX trial evaluating the investigational use of IMBRUVICA (ibrutinib) 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. IMBRUVICA, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech, and Pharmacyclics.
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"While 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 sub-population of patients," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development. "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."
DLBCL is a fast-growing type of NHL that affects B-cell lymphocytes, a type of white blood cell. DLBCL is the most common form of NHL in adults, accounting for up to 40 percent of all cases worldwide. DLBCL can arise in lymph nodes or outside of the lymphatic system, in the gastrointestinal tract, testes, thyroid, skin, breast, bone, or brain. There are two main subtypes of DLBCL: GCB subtype and non-GCB subtype, which includes unspecific subtype and ABC subtype. The disease occurs more commonly in the elderly and is slightly more prevalent in men.