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AstraZeneca Announces Positive Results In Phase III Trial On Leukemia Drug Calquence

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

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. Patients treated with Calquence had a statistically significantly lower incidence of all-grade atrial fibrillation compared with patients treated with ibrutinib, 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.

Separately, AstraZeneca said that 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 chronic lymphocytic leukaemia.

The trial met its primary endpoint at the data cut-off for the interim analysis after a median follow up of 28.3 months.

After a median follow up of 46.9 months, the ELEVATE-TN Phase III trial showed Calquence plus obinutuzumab reduced the risk of disease progression or death by 90% and as a monotherapy by 81% compared with chlorambucil plus obinutuzumab.

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