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Posted by on Apr 4, 2021 in Leukemia | 0 comments

In a nutshell

This review aims to analyze the trials that led to acalabrutinib (Calquence) gaining regulatory approval in the European Union for the treatment of chronic lymphocytic leukemia (CLL).  

Some background

Acalabrutrinib is a targeted therapy mainly used for the treatment of non-Hodgkin lymphoma. It inhibits Bruton tyrosine kinase (BTK), which allows the growth of cancer cells. 

In November 2020, acalabrutinib alone or in combination with obinutuzumab (Gazyva) in patients with newly diagnosed CLL was approved. Acalabrutinib alone was also approved for the treatment of relapsed/refractory (R/R) CLL.  

This review looks at the two trials that were carried out which led to European Union (EU) approval of acalabrutinib treatment in CLL. 

Methods & findings

This review involved data from two trials that were carried out to evaluate acalabrutinib treatment in patients with CLL.  

The first trial (ACE-CL-007), involved 535 patients with newly diagnosed CLL. Patients were treated with either acalabrutinib alone, acalabrutinib with obinutuzumab (AcalaObi), or chlorambucil (Leukeran) with obinutuzumab (ChlObi). The overall response rate (ORR) was significantly higher for patients treated with AcalaObi (93.9%) and acalabrutinib alone (85.5%) compared to ChlObi (78.5%). Patients treated with AcalaObi had an 86% longer time until the next therapy and those treated with acalabrutinib alone had a 76% longer time until the next therapy compared to those treated with ChlObi.

The second trial (ACE-CL-309) involved 310 patients with RR CLL. Patients were treated with acalabrutinib or with idelalisib (Zydelig)/rituximab (Rituxan) (IR) or bendamustine (Treanda)/rituximab (BR). Acalabrutinib treatment was associated with a 73% higher survival without cancer worsening compared to IR/BR treatment. 

The most common side effects for patients receiving acalabrutinib were headache, diarrhea, low level of white blood cells, nausea, and infections. 

The bottom line

This review recommended that acalabrutinib alone or in combination with obinutuzumab is a safe and effective treatment for newly diagnosed CLL and acalabrutinib alone is a beneficial treatment for patients with RR CLL.

Published By :

The Oncologist

Date :

Jan 23, 2021

Original Title :

The European Medicines Agency Review of Acalabrutinib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia.

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