Calquence met primary efficacy endpoint in head-to-head trial against ibrutinib in chronic lymphocytic leukaemia.- AstraZeneca

Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib . The trial also met a key secondary endpoint for safety, showing patients treated with Calquence had statistically significantly lower incidence of atrial fibrillation compared to patients treated with ibrutinib. Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications. Further hierarchical testing revealed no difference for Grade 3 or higher infections or Richter’s transformation. There was a descriptive trend for numerically favourable overall survival. Overall, the safety and tolerability of Calquence were consistent with the profile seen in the broader Calquence clinical development programme. ELEVATE-RR is the first Phase III trial to compare two Bruton’s tyrosine kinase (BTK) inhibitors in patients with CLL, the most common type of leukaemia in adults. Patients diagnosed with high-risk CLL may experience rapid worsening of their disease, requiring treatment.The data will be presented at a forthcoming medical meeting and shared with health authorities. ELEVATE-RR : ELEVATE-RR (ACE-CL-006) is a randomised, multicentre, open-label Phase III non-inferiority trial of Calquence versus ibrutinib in patients with previously treated CLL with high-risk features (presence of 17p deletion and/or 11q deletion). In the trial, 533 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence (100mg orally twice daily) until disease progression or unacceptable toxicity. Patients in the second arm received ibrutinib (420mg orally once daily) until disease progression or unacceptable toxicity.7The primary endpoint for the trial was PFS assessed by an independent review committee (non-inferiority; tested after 250 events). Secondary endpoints included incidence of atrial fibrillation, incidence of treatment-emergent Grade 3 or higher infections, incidence of Richter’s transformation (a condition in which CLL changes into an aggressive form of lymphoma) and overall survival.