Calquence Demonstrates Fewer Incidences of Atrial Fibrillation vs Ibrutinib in Patients with Leukaemia

Final results from the head-to-head ELEVATE-RR Phase III trial of AstraZeneca’s Calquence (acalabrutinib) demonstrated non-inferior progression-free survival (PFS) and statistically significantly fewer events of atrial fibrillation versus ibrutinib in adults with previously treated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

Separately, updated results at four years of follow-up from the ELEVATE-TN Phase III trial continued to show a strong PFS benefit for Calquence as combination therapy or as monotherapy in previously untreated patients with CLL.

At a median follow-up of 40.9 months, the ELEVATE-RR trial met its primary endpoint of PFS non-inferiority versus ibrutinib with a median PFS of 38.4 months in both arms (based on a hazard ratio [HR] of 1.0, 95% confidence interval [CI] 0.79-1.27). Patients treated with Calquence had a statistically significantly lower incidence of all-grade atrial fibrillation compared with patients treated with ibrutinib (9.4% versus 16.0%), a key secondary endpoint. Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Tolerability is a critical factor in treating patients with chronic lymphocytic leukaemia who often remain on medicines for many years and experience multiple comorbidities. The totality of the Calquence data at ASCO confirm our confidence in the favourable benefit-risk profile of this medicine, with over 40 months of follow-up in each of these two trials. Together, the results provide strong evidence that Calquence is a preferred option for people living with this chronic and devastating disease.”