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AstraZeneca Reports Positive Phase III Trial Results Of Calquence Against Ibrutinib In CLL

British drug major AstraZeneca Plc. (AZN.L,AZN) announced Monday positive high-level results from the ELEVATE-RR Phase III trial of Calquence against ibrutinib in chronic lymphocytic leukaemia or CLL.

In head-to-head trial, Calquence, a selective BTK inhibitor, met primary efficacy endpoint demonstrating non-inferior progression-free survival for adults with previously treated, high-risk 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 .

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 inhibitors in patients with CLL, the most common type of leukaemia in adults.

The data will be presented at a forthcoming medical meeting and shared with health authorities.

Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and approved for CLL in the EU and several other countries worldwide.

Calquence is under regulatory review in Japan for relapsed or refractory CLL. A Phase I trial is currently underway in Japan for the treatment of 1st-line CLL.

In the US and several other countries, Calquence is also approved for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials.

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