AZ, Acerta report additional Phase II data for Calquence in MCL

AstraZeneca plc (LSE:AZN; NYSE:AZN) and Acerta Pharma B.V. (Oss, the Netherlands) reported additional data from the Phase II ACE-LY-004 trial in 124 patients with relapsed or refractory mantle cell lymphoma (MCL) showing that Calquence acalabrutinib led to 12-month progression-free survival (PFS) and overall survival (OS) rates of 67% and 87%, respectively. Data were presented at the American Society of Hematology meeting in Atlanta in December.

In October, FDA granted accelerated approval to Calquence to treat MCL in adults who had received at least one prior therapy. The approval was based on data from ACE-LY-004 in which Calquence led to an overall response rate (ORR) of 81%, including a 40% complete response rate and 41% partial response rate (see BioCentury, Nov. 2, 2017)...