Early data demonstrate clinical activity of acalabrutinib in difficult to treat chronic lymphocytic leukaemia

Phase I/II trial findings add to growing body of data on acalabrutinib clinical profile

AstraZeneca and its haematology Centre of Excellence, Acerta Pharma, today announced preliminary results from the Phase I/II ACE-CL-001 clinical trial of acalabrutinib in subsets of patients with two difficult-to-treat forms of chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults. The trial includes data from individuals with intolerance to ibrutinib and those with Richter transformation, when CLL transforms into a more aggressive lymphoma. Findings were shared with the medical community during two oral presentations at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, USA.

Acerta Pharma Chief Executive Officer, Flavia Borellini, PhD, said: “The data at ASH further validate previous clinical trial findings and continue to demonstrate the potential of acalabrutinib in the treatment of B-cell malignancies.”

Investigator Jennifer R. Brown, MD, PhD and Director, Chronic Lymphocytic Leukemia Center, Dana-Farber Cancer Institute, said: “The acalabrutinib data in patients in difficult-tomanage settings support the continued exploration of acalabrutinib’s potential for the treatment of CLL.”

Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor shown to minimise off-target activity in pre-clinical studies. The Phase I/II findings presented at ASH are part of an extensive and ongoing clinical development programme for acalabrutinib in B-cell cancers including CLL, mantle cell lymphoma (MCL), Waldenström macroglobulinemia, follicular lymphoma and diffuse large B-cell lymphoma.

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