AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) hit the primary endpoint in a Phase III study in chronic lymphocytic leukaemia (CLL).
In the ELEVATE-RR trial, Calquence demonstrated non-inferior progression-free survival (PFS) compared to Janssen’s BTK inhibitor Imbruvica (ibrutinib) in adult patients with previously-treated, high risk CLL – the primary endpoint of the study.
AZ’s drug also met a key secondary endpoint for safety, with Calquence-treated patients demonstrating a statistically significant lower incidence of atrial fibrillation compared to patients treated with Imbruvica.
In a statement, AZ added that there was also a ‘descriptive’ trend for numerically favourable overall survival for Calquence.
“With over forty months of follow-up, today’s results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said José Baselga, executive vice president, Oncology R&D at AZ/
“The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence,” he added.
AZ said that it will present data from the ELEVATE-RR trial at future medical meeting and will also share the results with health authorities.
CLL is the most common type of leukaemia in adults – in CLL, an excess amount of blood steam cells in the bone marrow become abnormal lymphocytes, with these abnormal cells having difficulty in fighting infections.