ASH 2015. ABSTRACT 495. Results from the International, Randomized Phase 3 Study of Ibrutinib Versus Chlorambucil in Patients 65 Years and Older with Treatment-Naïve CLL/SLL (RESONATE-2TM)

Alessandra Tedeschi et al.

Results:

 

Conclusions: Treatment with single-agent ibr was superior to clb in terms of PFS, OS, ORR, EFS and hematologic improvement in treatment-naïve older CLL/SLL patients, with an 84% reduction in risk of death, and an acceptable safety profile.

CARE FACULTY PERSPECTIVE: This trial is ground breaking as it is the first to investigate a novel CLL agent in the front-line setting. Ibrutinib has shown to have good data and high efficacy in relapse setting. The results of this trial were positive, with significant improvements in survival and safety. We are now seeing a high response with ibrutinib across all high-risk subgroups, and there appears to be a significant improvement in hematologic function. In terms of safety, we are seeing consistency from previous trials and the majority of patients are able to continue on therapy despite some adverse events (eg. bleeding and atrial fibrillation). AEs need to be proactively managed. There are potential limitations that exist in terms of the application of this data to the Canadian landscape. Firstly, the comparator arm of chlorambucil is not currently considered a standard in Canadian practice. It is also important to note that the inclusion criteria was less strict than that for the CLL11 trial. Patients included in this study were not as likely to be frail. Moreover, it will be important to determine how to better identify patients that may benefit from this strategy because of the high cost. We need more information about funding and future access in Canada.
Overall, we are eventually looking forward to having oral agents such as ibrutinib enter the Canadian landscape as they offer significant benefits for CLL patients – both in the front-line and relapsed setting.