Adding Arzerra (ofatumumab) to the chemotherapy agent bendamustine did not delay disease progression or death in indolent non-Hodgkin’s lymphoma patients whose disease failed to respond to Rituxan (rituximab) treatment, according to a clinical trial.
Based on the findings, the Phase 3 trial – called COMPLEMENT A+B (NCT01077518) – failed its primary objective.
“We are disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial. The completion of this Phase III study, which began in 2010, would not have been possible without the generous participation of the patients and their families, and we are most grateful for this,” Jan van de Winkel, PhD, the CEO of Genmab, said in a press release.
“The full data will be submitted for publication at a future medical conference and we hope that these will provide a better understanding of this result,” van de Winkel added.
The study, sponsored by Novartis, was designed to compare the safety and effectiveness of Arzerra and bendamustine vs. bendamustine alone in B-cell non-Hodgkin’s lymphoma patients who did not respond to Rituxan or a Rituxan-containing regimen.
This combination had shown promising signs of effectiveness and a good safety profile in a Phase 2 trial (NCT01108341) for these patients.
The Phase 3 trial included 346 participants recruited from 145 centers worldwide, who received eight cycles of bendamustine chemotherapy, with or without Arzerra, every three weeks while on bendamustine and monthly thereafter, for a total of 12 doses. Both therapies were delivered intravenously.
The study’s primary goal was the proportion of patients who were alive and without signs of disease worsening after 89 months (7.5 years). Secondary measures included clinical benefit, overall response rate, and the safety and tolerability of the combination.
The combination, however, failed to delay the progression of the disease. While the data was not disclosed, the company expects to present trial results at an upcoming medical conference.
Arzerra, which works by binding to the CD20 molecule present on the surface of B-cells, is already approved in the U.S. for the treatment of chronic lymphocytic leukemia patients who no longer respond to chemotherapy.
The molecule was developed and marketed by Genmab under a co-development and commercialization agreement with Novartis.
Arzerra is also under clinical investigation as a potential therapy for other diseases, including relapsing multiple sclerosis, Crohn’s disease, and Wegener’s granulomatosis.
