ELEVATE-RR head-to-head trial data presented at ASH showed patients on ibrutinib experienced a 37% higher burden of adverse events of any grade while on treatment vs. patients on Calquence.
These data demonstrated Calquence reduced the risk of disease progression or death by 71% versus IdR/BR as assessed by investigators at three years (based on a hazard ratio [HR] of 0.29; 95% confidence interval [CI]: 0.21-0.41; p<0.0001). similar clinical benefits were observed in an exploratory analysis comparing each regimen with calquence. safety and tolerability of calquence were consistent with earlier findings, with no new safety signals identified.
Additional safety analyses from the ELEVATE-RR Phase III trial were also presented at ASH to further characterise adverse events (AEs) related to treatment with Bruton’s tyrosine kinase (BTK) inhibitors Calquence and ibrutinib. Overall, patients on ibrutinib experienced a 37% higher burden of AEs of any grade versus patients on Calquence. For any grade atrial fibrillation/flutter, a key secondary endpoint in the ELEVATE-RR trial, median time to onset was longer for Calquence versus ibrutinib (28.8 versus 16.0 months), and cumulative incidence was lower at all timepoints from six months through two years.
Additionally, the ELEVATE-RR Phase III trial showed incidence of all-grade atrial fibrillation/flutter was lower for Calquence across subgroups of age, prior line of therapy and among patients without prior history of heart complications. Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications. Results were presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition.
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