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AstraZeneca: Calquence Trial In Chronic Lymphocytic Leukaemia Met Primary Goal

British drug major AstraZeneca Plc (AZN.L,AZN) announced Tuesday that the Phase III ASCEND trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia or CLL met primary endpoint.

The positive results showed a statistically-significant and clinically-meaningful improvement in progression-free survival with Calquence monotherapy compared to a combination regimen of rituximab plus physician's choice of idelalisib or bendamustine.

The safety and tolerability of Calquence was consistent with the known profile, the company noted.

According to the company, Calquence is the first Bruton tyrosine kinase or BTK inhibitor to show benefit in a Phase III trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory CLL.

ASCEND is the first of two Phase III CLL trials expected to read out in 2019. The second is ELEVATE-TN in treatment-naïve, front-line CLL.

Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma or MCL in the US, Brazil, the UAE, and Qatar. It is being developed for the treatment of CLL and other blood cancers.

AstraZeneca and its haematology research and development arm Acerta Pharma are currently evaluating Calquence in 26 clinical trials.

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