Efficacy

Lumoxiti (moxetumomab pasudotox) for Hairy Cell Leukemia

Lumoxiti (moxetumomab pasudotox) is a CD22-directed cytotoxin approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Its efficacy was established in a single-arm, open-label clinical trial which included 80 participants with relapsed or refractory HCL. The trial measured the rate of durable complete response (CR), defined as the maintenance of hematologic remission for more than 180 days after achieving CR.

The results demonstrated that 30% of patients achieved a durable CR, and 41% of patients achieved an objective response rate (ORR). The median duration of CR was not reached, indicating a potential for long-lasting responses. These results suggest that Lumoxiti provides a significant clinical benefit for patients with HCL who have limited treatment options due to the relapsed or refractory nature of their disease.

Bosulif (bosutinib) for Chronic Myelogenous Leukemia

Bosulif (bosutinib) is a tyrosine kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. The efficacy of Bosulif was evaluated in a single-arm trial for patients with chronic phase CML and in a single-arm trial for patients with accelerated or blast phase CML or Ph+ acute lymphoblastic leukemia.

In the chronic phase CML trial, the major cytogenetic response (MCyR) rate was 34% in previously treated patients. For those patients who were treated with Bosulif as first-line therapy, the rates of complete cytogenetic response (CCyR) and major molecular response (MMR) were 77.2% and 52.5%, respectively, by 12 months. These results indicate that Bosulif is an effective treatment option for patients with CML, including those who have not responded to or cannot tolerate other tyrosine kinase inhibitors.