AstraZeneca and MedImmune, its global biologics research and development arm, presented results from the Phase III ‘1053’ clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukemia who had received at least two prior lines of therapy. Moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin, showed a 75% objective response rate, a 41% complete response rate, and a 30% durable CR rate. The majority of patients with a complete response had a durable response and achieved a negative minimal residual disease status. The primary endpoint of the trial was durable CR, which is defined as CR with HR for greater than180 days. The median time to HR was 1 month. The most frequent treatment-related adverse events were nausea, peripheral edema, headache, and pyrexia; 8% had infections and 3% had neutropenia deemed treatment-related. Three patient deaths occurred, none of which were determined to be treatment-related. Treatment-related AEs leading to discontinuation were hemolytic uremic syndrome, capillary leak syndrome, and increased blood creatinine. Seven patients had CLS and seven had HUS; this includes four patients who had both CLS and HUS. CLS and HUS were manageable and reversible. In April 2018, AstraZeneca announced that the Food and Drug Administration accepted the Biologics License Application for moxetumomab pasudotox for the treatment of adult patients with HCL who have received at least two prior lines of therapy. The BLA is based on results from the Phase III ‘1053’ clinical trial. The FDA has granted Priority Review status with a Prescription Drug User Fee Act action date set for the third quarter of 2018.
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