AbbVie and Janssen have announced that Imbruvica (ibrutinib) failed to achieve the primary endpoint in a late-stage study assessing its use in patients with treatment-naïve diffuse large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma.
The Phase 3 DBL3001 study found that Imbruvica did not improve event-free survival in previously untreated diffuse large B-cell lymphoma patients. However, “clinically meaningful improvements” were observed in a patient sub group population.
As stated by Dr Thorsten Graef, Head of Clinical Development at AbbVie’s Pharmacyclics: “The nature of research is such that some studies succeed and others do not. We continue to believe that ibrutinib has great untapped potential as a cancer treatment alone or in combination.”
While Imbruvica has been approved by the FDA for a total of eight different indications, the study found that the drug in combination with the chemotherapy R-CHOP was not more effective than chemotherapy alone.
“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,” Dr Graef added. “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 programme and anticipate results from several studies in the future.”