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Calquence head-to-head results versus ibrutinib
Calquence head-to-head results versus ibrutinib.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9542A\n AstraZeneca PLC\n 07 June 2021\n \n \n \n \n 7 June 2021 07:00 BST\n \n \n \n Calquence \n \n \n demonstrated fewer incidences of atrial fibrillation \n \n \n versus ibrutinib in previously treated patients with chronic lymphocytic leukaemia and sustained patient benefit at four years in the front-line setting\n \n \n \n \n \n \n ELEVATE-RR head-to-head trial in previously treated patients showed less cardiovascular toxicity and fewer discontinuations due to adverse events for Calquence versus ibrutinib\n \n \n \n \n \n \n Long-term follow up from ELEVATE-TN trial in front-line setting showed \n \n \n Calquence\n \n \n maintained progression-free survival and favourable tolerability at four years\n \n \n \n \n \n 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.1\n \n 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.\n \n 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.2 Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications.3\n \n John C. Byrd, MD, Distinguished University Professor, The Ohio State University, and lead investigator of the ELEVATE-RR trial, said: \"Cardiac adverse events are an important consideration for treating chronic lymphocytic leukaemia patients with Bruton's tyrosine kinase inhibitors because they can produce significant morbidity in some cases and also lead pa...