Efficacy

Copiktra (Duvelisib) Efficacy in Treating Leukemia

Copiktra (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and is specifically a dual inhibitor of PI3K-delta and PI3K-gamma. It has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. The efficacy of Copiktra in CLL/SLL was primarily shown in a clinical trial that measured overall response rate and duration of response. Patients treated with Copiktra demonstrated a significant improvement in these endpoints compared to the control group.

In addition to CLL/SLL, Copiktra has also shown efficacy in treating follicular lymphoma (FL) after at least two prior systemic therapies. While FL is a type of non-Hodgkin lymphoma and not classified under the traditional leukemia categories, the drug's action on PI3K pathways is relevant for certain leukemic conditions that share similar signaling abnormalities. However, its efficacy for other types of leukemia beyond CLL/SLL has not been established in the context of FDA-approved indications.

Daurismo (Glasdegib) Efficacy in Treating Leukemia

Daurismo (glasdegib) is a hedgehog pathway inhibitor approved by the FDA for use in combination with low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Clinical trials have demonstrated that patients treated with the combination of glasdegib and LDAC had a significant improvement in overall survival compared to those treated with LDAC alone. This suggests that glasdegib adds a therapeutic advantage in this specific patient population.

The efficacy of Daurismo in the treatment of AML is attributed to its mechanism of action, which involves inhibiting the hedgehog signaling pathway, a pathway known to be involved in the proliferation and survival of cancer cells, including leukemic cells. The approval of Daurismo for AML was based on the results of a multicenter, randomized, open-label study, where the median overall survival was notably higher in the glasdegib plus LDAC group compared to the LDAC alone group. It is important to note that the use of Daurismo is not indicated for patients with other types of leukemia outside of newly-diagnosed AML in the specified patient population.