Researchers reported at the annual American Society of Clinical Oncology meeting in Chicago that chronic lymphoid leukemia (CLL) patients treated with Imbruvica™ (ibrutinib) showed improved survival when compared to those treated with Arzerra® (ofatumumab). Because the Imbruvica group showed a significant advantage in progression-free survival at an interim point, the trial was halted and Arzerra patients were crossed over to the Imbruvica treatment.
Imbruvica was designated by the FDA as a breakthrough therapy warranting accelerated approval for CLL. Arzerra is an FDA-approved treatment for patients with previously treated CLL.
The study, conducted by Dr. John Byrd at the Ohio State University Comprehensive Cancer Center, enrolled 391 patients with relapsed or refractory CLL or small-cell lymphoma. The enrollees had all progressed on or were considered refractory to one or more prior treatments.
One group was randomized to Imbruvica, the other to Arzerra. Progression-free survival (time of was the primary endpoint; secondary endpoints included overall survival and overall response rate.
At six months, the Imbruvica group had a progression-free survival of 88% versus 65% for the Arzerra group. In terms of overall survival at 12 months, the Imbruvica patients had a rate of 90%, whereas the Arzerra group was at 81%.
Researchers found that the proportion of patients with grade 3/4 adverse events was comparable in the two groups (51% with Imbruvica and 39% with Arzerra).
Reference: Byrd JC, et al. Randomized comparison of ibrutinib versus ofatumumab in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the phase III RESONATE trial. ASCO 2014; Abstract LBA7008.
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