Here at EHA we presented the date from a phase III multicentre study, ASCEND is the name, where we compare the novel BTK inhibitor acalabrutinib to a physician’s choice between bendamustine plus rituximab or idelalisib plus rituximab in the relapsed/refractory setting of chronic lymphocytic leukaemia.
This is the first randomised study comparing monotherapy BTK inhibition against classic, traditional now, therapies for relapsed or refractory CLL, which is bendamustine plus rituximab but also idelalisib plus rituximab. The data show that indeed acalabrutinib is more effective, so the PFS is not yet reached after a median follow-up of more than sixteen months, while instead the other two drugs had a PFS that is around sixteen months. On the other side, the drug is also better tolerated in comparison to idelalisib and also in comparison to the chemotherapy with a profile that is typical of BTK inhibition but at a lower frequency. We see, for example, minor bleeding in only one patient out of four, in around 25% of the patients.
What were the main conclusions?
This study shows for the first time that in a randomised fashion that monotherapy acalabrutinib can be an improvement in the current treatment strategy for CLL in the relapsed/refractory setting, and therefore we might envision that in the future it will be included in the algorithm, the therapeutic algorithm, for this disease.
When might this monotherapy be approved?
We don’t know that. Of course, this is a study that together with another study, ELEVATE, for which has been released a press release indicating that indeed the study met the endpoint. These two studies will be the basis for the approval both in the US and in Europe, so we might think next year something will happen.
How might these results change clinical practice?
This will change clinical practice because it will give another additional option to the physician to treat patients with chronic lymphocytic leukaemia. The ELEVATE study will be in first line, the ASCEND study that I presented will be in the relapsed refractory setting, so the doctors will have another option of a very well-tolerated drug, especially very effective in both first-line and in the relapsed refractory setting.
I think that of course this is just underscoring the fact that CLL is an evolving field, and indeed we have the luck and the fortune to have new drugs coming to the studies for the patients, but also finally or fully to the market.