Janssen Pharmaceutical Companies of Johnson & Johnson has reported negative results from the PHOENIX trial after the study failed to meet its primary endpoint.
PHOENIX is a Phase lll, randomised, double-blind, placebo-controlled, multicentre trial designed to analyse the investigational use of Imbruvica (ibrutinib) for the treatment of newly diagnosed non-Germinal Center B cell (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL).
The trial also compared Imbruvica with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) against R-CHOP, the existing standard of care in DLBCL.
Its primary endpoint included event-free survival in patients with a non-GCB subtype of DLBCL, including an activated B-cell-like (ABC) subtype of DLBCL.
DLBCL is an aggressive form of non-Hodgkin lymphoma (NHL) that affects a type of white blood cell called B-cell lymphocytes.
Janssen Research and Development Clinical Development and Global Medical Affairs vice-president Craig Tendler said: “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.
“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.”
Janssen Biotech, along with Pharmacyclics, has developed Imbruvica, an inhibitor of Bruton's tyrosine kinase (BTK) protein, which transmits signals that cause B-cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.