AZ reports Phase III data for hairy cell leukemia candidate

AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data from the Phase III 1053 trial in 80 patients with relapsed or refractory hairy cell leukemia who have received at least two prior therapies showing that moxetumomab pasudotox (formerly CAT-8015) led to a durable complete response rate, the primary endpoint defined as achieving a complete response with hematologic remission for >180 days, of 30% at a median follow-up of 16.7 months. Moxetumomab pasudotox led to an overall response rate (ORR) of 75% and a complete response rate of 41%. Median duration of response and median progression-free survival (PFS) have not yet been reached in the open-label, international trial. The data were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago.

In April, FDA accepted and granted Priority Review to a BLA for moxetumomab pasudotox to treat hairy cell leukemia in adults who have received at least two prior therapies. The PDUFA date is in 3Q18 (see "FDA Reviewing AZ's Hairy Cell Leukemia Candidate")...