81% overall response rate and 40% complete response rate by investigator assessment with consistent results observed across pre-specified subgroups of patients1

CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the open-label, single-arm Phase II ACE-LY-004 clinical trial, which served as the basis for the recent US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib). The findings were presented for the first time during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA and demonstrate the safety profile and efficacy of acalabrutinib in the management of previously-treated mantle cell lymphoma (MCL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The results presented for the first time to the medical community highlight the potential of Calquence as a treatment for people with relapsed or refractory mantle cell lymphoma, a life-threatening form of blood cancer. These data reinforce the important progress of our clinical development programme as well as our commitment to advancing the treatment of patients with blood cancers.”

Michael L. Wang, MD, Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, and Principal Investigator of the ACE-LY-004 MCL clinical trial, said: “Most people living with mantle cell lymphoma will unfortunately relapse, and new treatment options are greatly needed. As shown by the consistent overall response rates observed in this trial across several pre-specified subgroups, acalabrutinib is a welcome new treatment option for certain patients with this aggressive blood cancer.”

Summary of key investigator-assessed efficacy results from ACE-LY-004 (15.2 months median follow-up):