Dr. Danilov on ELEVATE-TN Trial Results in CLL

Alexey V. Danilov, MD, PhD
Published: Thursday, Feb 20, 2020



Alexey V. Danilov, MD, PhD, associate professor of medicine, Program in Molecular and Cellular Biology, Cancer Biology Graduate Program, Oregon Health & Science University School of Medicine, discusses the findings of the phase III ELEVATE-TN trial in treatment-naïve patients with chronic lymphocytic leukemia (CLL).

The ELEVATE-TN trial randomized treatment-naïve patients with CLL to acalabrutinib (Calquence) in combination with obinutuzumab (Gazyva), single-agent acalabrutinib, or chlorambucil in combination with obinutuzumab, explains Danilov. Results showed a progression-free survival advantage in both acalabrutinib arms, marking the first study to demonstrate an advantage for the combination of acalabrutinib plus obinutuzumab versus acalabrutinib alone; however, the study was not powered to assess that difference, says Danilov.

Responses were up to 94% in patients who received acalabrutinib. Further, toxicities were low and less than 10% of patients discontinued acalabrutinib due to adverse events (AEs). Although atrial fibrillation is certainly a concern with BTK inhibitors, approximately around 3% of patients in this study experienced this AE on acalabrutinib, concludes Danilov.
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Alexey V. Danilov, MD, PhD, associate professor of medicine, Program in Molecular and Cellular Biology, Cancer Biology Graduate Program, Oregon Health & Science University School of Medicine, discusses the findings of the phase III ELEVATE-TN trial in treatment-naïve patients with chronic lymphocytic leukemia (CLL).

The ELEVATE-TN trial randomized treatment-naïve patients with CLL to acalabrutinib (Calquence) in combination with obinutuzumab (Gazyva), single-agent acalabrutinib, or chlorambucil in combination with obinutuzumab, explains Danilov. Results showed a progression-free survival advantage in both acalabrutinib arms, marking the first study to demonstrate an advantage for the combination of acalabrutinib plus obinutuzumab versus acalabrutinib alone; however, the study was not powered to assess that difference, says Danilov.

Responses were up to 94% in patients who received acalabrutinib. Further, toxicities were low and less than 10% of patients discontinued acalabrutinib due to adverse events (AEs). Although atrial fibrillation is certainly a concern with BTK inhibitors, approximately around 3% of patients in this study experienced this AE on acalabrutinib, concludes Danilov.

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