AbbVie and Janssen announce failure of cancer drug Imbruvica in Phase 3 trial
pharmafile | July 12, 2018 | News story | Research and Development | AbbVie, Cancer, FDA, Janssen, approval
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.”
Louis Goss
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