Sharman discusses results from the ELEVATE-TN study in CLL

Jeff Sharman, MD, medical director of hematology research at US Oncology, discusses results of the ELEVATE-TN study (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 | Patients treated with a combination of acalabrutinib and obinutuzumab have a progression-free survival of 78% at 6 years. These are some of the best data we've ever seen in CLL. We're far from a median here, so this is a highly effective regimen for these patients. [and it is] also very well tolerated.

0:32 | We often divide patients into certain risk categories. So if they IGHV unmutated, they tend to achieve less favorable treatment outcomes. In this study, this had no impact on the outcome of patients with acalabrutinib. Likewise, patients with 17p are among the patients at highest risk. In these patients, the benefit of obinutuzumab was not greater than that of acalabrutinib alone.

0:57 | With [Bruton’s tyrosine kinase (BTK)] inhibitors, there were a lot of questions about ventricular arrhythmias or atrial fibrillation and so on. We have a separate presentation that summarizes 5 different prospective CLL studies, 3 randomized trials, and 2 single-arm studies, and because 3 of those were randomized trials, we were actually able to compare the atrial fibrillation rates with patients treated with agents other than BTK inhibitors. In fact, we found numerically fewer ventricular arrhythmias in patients treated with acalabrutinib compared to their various control groups.

1:35 | We also observed that the incidence of atrial fibrillation was quite low and consistent with the baseline risk in the population. At least based on our current understanding, we do not see a large cardiac signal with acalabrutinib, which may distinguish it from some other BTK inhibitors.