AbbVie and Johnson & Johnson’s Imbruvica has failed to meet its key target in a late stage study assessing its use in patients with treatment-naïve diffuse large B-cell lymphoma.
The Phase III DBL3001 study did not show additional efficacy when adding Imbruvica (ibrutinib) to the existing standard of first-line care – a regimen of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
However, “clinically meaningful improvements” were observed in a patient sub-population “warranting further analysis,” the groups stressed.
Imbruvica is currently approved in the US across six disease areas and in eight treatment indications, winning its first clearance for adults with Mantle cell lymphoma who have received at least one prior therapy in November 2013.
"Since its first US FDA approval in 2013, Imbruvica has redefined standard of care in many different blood cancers – several of which had little to no treatment options available to patients before," said Thorsten Graef, head of clinical development at AbbVie group Pharmacyclics, an AbbVie company.
"We continue to believe that ibrutinib has great untapped potential as a cancer treatment alone or in combination. Together with our global partner Janssen, we are advancing our robust ibrutinib scientific development program and anticipate results from several studies in the future."
Full results from this study will be presented at an upcoming scientific conference and published in a peer-reviewed medical journal.
DLBCL is a fast-growing type of non-Hodgkin lymphoma (NHL) that affects B-cell lymphocytes. It can arise in lymph nodes or outside of the lymphatic system, in the gastrointestinal tract, testes, thyroid, skin, breast, bone, or brain.