Efficacy

Lumoxiti (moxetumomab pasudotox) Efficacy in Treating Hairy Cell Leukemia

Lumoxiti (moxetumomab pasudotox) is a CD22-directed cytotoxin indicated 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. The efficacy of Lumoxiti was primarily demonstrated in a pivotal single-arm, open-label clinical trial that included 80 patients with relapsed or refractory HCL. The trial's primary endpoint was the rate of durable complete response (CR), defined as the maintenance of hematologic remission for more than 180 days after achieving a CR.

In this trial, Lumoxiti achieved a 30% durable CR rate and a 41% overall response rate (ORR), which includes both complete responses and partial responses. These results indicate that Lumoxiti can induce a significant number of responses in this patient population, with some patients achieving a long-term remission of their disease. The median duration of response has not been reached, suggesting that the responses can be durable and long-lasting for some patients.

Brukinsa (zanubrutinib) Efficacy in Treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Brukinsa (zanubrutinib) is a Bruton's tyrosine kinase (BTK) inhibitor approved for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. While Brukinsa is not specifically approved for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), it has shown promising results in clinical trials involving these types of leukemia. In a phase 1/2 trial, zanubrutinib demonstrated high overall response rates in patients with relapsed/refractory CLL/SLL. The trial included patients who had received at least one prior therapy, and zanubrutinib achieved an ORR of 96.9% in the CLL/SLL cohort.

Furthermore, in a phase 3 trial comparing zanubrutinib to ibrutinib in patients with CLL or SLL, zanubrutinib met the primary endpoint of non-inferiority in overall response rate and also showed a trend toward improved efficacy in terms of progression-free survival, though the final data on long-term outcomes are still pending. These results suggest that Brukinsa could be an effective treatment option for patients with CLL/SLL, potentially offering an alternative to other BTK inhibitors with a favorable safety and efficacy profile.