Sharman Discusses ELEVATE-TN Trial Findings in CLL

Jeff Sharman, MD, medical director of hematology research at US Oncology, discusses findings from the ELEVATE-TN trial (NCT02475681) of acalabrutinib (Calquence) with or without obinutuzumab (Gazyva) for the treatment of patients with treatment-naive chronic lymphocytic leukemia (CLL). 

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0:10 | The patients treated with a combination of acalabrutinib and obinutuzumab have a 78% progression-free survival at 6 years, so that is some of the best data we have ever seen in CLL. We are nowhere close to a median on that at all, so this is a highly effective regimen for these patients [and it is] very well-tolerated as well.

0:32 | Oftentimes we divide patients into certain risk categories. So, if they are IGHV unmutated, they tend to have less favorable outcomes with therapies. In this study that did not impact patients’ outcome on acalabrutinib. Similarly, those patients with 17p are some of the highest risk patients; those patients did not get additional benefit from obinutuzumab over acalabrutinib alone.

0:57 | With [Bruton’s tyrosine kinase (BTK)] inhibitors, there have been a lot of questions about either ventricular arrhythmias or atrial fibrillation and so forth. We have a separate presentation that aggregates 5 different prospective CLL studies, 3 randomized studies and 2 single-arm studies, and because 3 of them were randomized studies, were actually able to compare rates of atrial fibrillation to patients treated with agents other than BTK inhibitors. Really, we saw numerically fewer ventricular arrhythmias amongst patients who were treated with acalabrutinib relative to their various control arms.

1:35 | We also observed that rates of atrial fibrillation were quite low and appeared consistent with baseline risk in the population. At least from our understanding right now, we do not see much of a cardiac signal arising from acalabrutinib, which may differentiate it and apart from some of the other BTK inhibitors.