Therapy Areas: Cardiovascular
AstraZeneca's Calquence phase III ASCEND trial meets primary endpoint
8 May 2019 -

AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Tuesday positive results from the phase III ASCEND trial of Calquence(acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL).

The company said results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Calquence monotherapy compared to a combination regimen of rituximab plus physician's choice of idelalisib or bendamustine. Importantly, the safety and tolerability of Calquence was consistent with the known profile.

According to the company, Calquence is the first BTK inhibitor to show benefit in a phase III trial as a monotherapy, as compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukaemia.

Within AstraZeneca's robust development programme for Calquence, ASCEND is the first of two phase III CLL trials expected to read out in 2019. The second is ELEVATE-TN (ACE-CL-007) in treatment-naïve, front-line CLL.

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

Also, Calquence (acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.

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