Adding Imbruvica (ibrutinib) to a standard chemotherapy regimen does not improve outcomes for people newly diagnosed with diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL), a Phase 3 trial reports.
The trial — called DBL3001 (NCT01855750) — tested Imbruvica in patients with non-germinal center B cell (GCB) or activated B-cell (ABC) subtypes of the disease, which have limited responses to treatment.
While the combination was no better than R-CHOP chemotherapy at delaying disease progression, time to next therapy, or death — the study’s main measures — researchers did note improvements in a subpopulation of patients, warranting further analysis.
“Since its first U.S. 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,” Thorsten Graef, MD, PhD, head of clinical development at Pharmacyclics, an AbbVie company, said in a press release. “We continue to believe that ibrutinib has great untapped potential as a cancer treatment alone or in combination.”
The trial included 838 patients with previously untreated GCB or ABC subtypes of DLBCL. Participants were randomly assigned Imbruvica plus R-CHOP chemotherapy or chemotherapy alone.
R-CHOP is the current standard of care for DLBCL patients. It is comprised of five agents — Rituxan (rituximab), cyclophosphamide, doxorubicin, vincristine, and prednisone.
The trial’s main goal was to extend event-free survival, deemed as the time a patient lives without disease worsening or without initiating of a subsequent lymphoma therapy.
But researchers also examined the time until disease progression or death, complete response rate, time to symptom worsening, and other measures of Imbruvica’s distribution and behavior in the body.
While the combination led to even-free survival at rates similar to the chemotherapy regimen alone, researchers reported clinically meaningful improvements in a patient subgroup and intent to analyze this finding further. No further information was given.
“These medical achievements reflect our objective of focusing research where there is great unmet patient need and understanding that the nature of research is such that some studies succeed and others do not,” Graef said. “Together with our global partner Janssen, we are advancing our robust ibrutinib scientific development program and anticipate results from several studies in the future.”
AbbVie is planning to reveal the full results from the DBL3001 study at an upcoming scientific meeting.
Imbruvica is a Bruton’s tyrosine kinase inhibitor jointly developed and commercialized by Pharmacyclics and Janssen Biotech. It was first approved in the U.S. in 2013 and is currently used for the treatment of five B-cell blood cancers and chronic graft-versus-host-disease, for a total of eight indications.