Acalabrutinib exhibits comparable efficacy, superior safety to ibrutinib for CLL
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Acalabrutinib conferred a similar PFS benefit as ibrutinib for adults with previously treated high-risk chronic lymphocytic leukemia, according to topline results of a randomized phase 3 trial.
However, patients assigned acalabrutinib (Calquence, AstraZeneca) exhibited significantly lower risk for atrial fibrillation than those assigned ibrutinib (Imbruvica; Janssen, Pharmacyclics).
The ELEVATE-RR trial is the first phase 3 trial to compare two Bruton tyrosine kinase (BTK) inhibitors for patients with CLL.
The trial met its primary endpoint, showing noninferior PFS among acalabrutinib-treated patients. The trial also met a key secondary endpoint for safety, with results showing a statistically significant reduction in incidence of atrial fibrillation in the acalabrutinib group.
Additional testing showed no difference in grade 3 or higher infections or Richter’s transformation between groups.
Acalabrutinib exhibited a safety profile consistent with that observed during prior studies of the agent.
“With over 40 months of follow-up, today’s results confirm that Calquence — a selective BTK inhibitor — displays superior safety in atrial fibrillation without compromising efficacy,” José Baselga, MD, PhD, executive vice president for oncology research and development with AstraZeneca, said in a company-issued press release. “The totality of the data confirm our confidence in the favorable benefit-risk profile of Calquence.”
Complete data from the trial will be submitted for presentation at a medical meeting.
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