The abstract is the follow-up at up to 5.5 years of the RESONATE trial. The RESONATE-2 trial is a trial designed for elderly people comparing safety and efficacy of ibrutinib versus chlorambucil that at the time of the protocol design was the standard of care for the elderly. So it’s the first study comparing a chemotherapy based regimen with a chemo-free regimen in the elderly population. The follow-up was important and is important because, first of all, it’s important to verify if the benefit of ibrutinib is maintained and to see if there are safety signals emerging with continuous ibrutinib treatment.
Results were maintained in terms of progression free survival and overall survival and there were no new safety signals or adverse events worsening. At least there was a reduction of prevalence of adverse events following ibrutinib treatment.
What were the increases in PFS and OS?
The progression free survival now is 70% for patients treated with ibrutinib versus 12% for patients treated with chlorambucil and the overall survival also is better for patients treated with ibrutinib at this moment when compared to patients treated with chlorambucil, despite there was a possibility to cross over. So overall survival benefit is still ongoing although there was 57% of patients crossed over to receive ibrutinib as salvage treatment.
What are the implications of this research?
The implications are fundamental for elderly people. The elderly do not tolerate very well chemo-immunotherapy, even frail patients, patients with comorbidities. Elderly means a lot of things in clinical life, in everyday clinical practice. Ibrutinib is very well tolerated so we have a chemo-free treatment for the elderly population, very well tolerated even in patients with comorbidities as the patients that were enrolled in the study.