Do you find ELEVATE-RR data and study design compelling to start preferentially using acalabrutinib over ibrutinib?
Is the non-inferiority margin of 1.429 sufficient, how was this selected?
Is the open label (rather than blinded) study design of any concern?
Is the reduced cardiac event rate significant enough to impact your practice?
Answer from: Medical Oncologist at Academic Institution
The inferiority design of the ELEVATE-RR included a 1.429 margin, but the hazard ratio between treatments was 1.0 as related to DFS and 0.82 (favoring acalabrutinib) for OS. This improved OS likely is reflective of lower cardiac events and other adverse events. To me, this is sufficiently beneficial...
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Answer from: Medical Oncologist at Academic Institution
Yes, I think that the data clearly shows that the two drugs are equivalent in efficacy, which is also supported by other studies of both drugs with similar efficacy characteristics. If this is the case, then any improvement in safety for one drug over the other can justify the use of one agent, in m...
Answer from: Medical Oncologist at Academic Institution
Yes, the data of ELEVATE-RR is compelling for the safety of acalabrutinib over ibrutinib. This was somewhat already evident from prior phase 1-2 studies of acalabrutinib where the toxicity profile appeared to be better than ibrutinib in cross trial comparison. Now with this phas...
Answer from: Medical Oncologist at Academic Institution
Yes, I do find the data and study design compelling, as a culmination of earlier data that also clearly suggested that acalabrutinib is better tolerated than ibrutinib. I have already been using acalabrutinib preferentially over ibrutinib based on those data and personal experience. The non-inferior...