Efficacy

Besponsa (Inotuzumab Ozogamicin) Efficacy in Leukemia

Besponsa (inotuzumab ozogamicin) is an antibody-drug conjugate specifically indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The efficacy of Besponsa was established through a pivotal phase 3 clinical trial known as INO-VATE ALL. In this study, patients treated with Besponsa demonstrated a higher rate of complete remission (CR) compared to those who received standard chemotherapy. The CR rates with Besponsa were approximately 80.7%, with a median duration of remission of 4.6 months, which significantly improved the outcomes for patients with this aggressive type of leukemia.

Furthermore, Besponsa has shown to improve overall survival in patients with relapsed or refractory ALL. In the INO-VATE ALL trial, the median overall survival was 7.7 months for patients treated with Besponsa compared to 6.7 months for those treated with standard therapy. This improvement in survival is particularly notable given the poor prognosis of patients with relapsed or refractory B-cell precursor ALL.

Daurismo (Glasdegib) Efficacy in Leukemia

Daurismo (glasdegib) is approved 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. The efficacy of Daurismo, in combination with low-dose cytarabine (LDAC), was demonstrated in a randomized clinical trial which showed a significant improvement in median overall survival compared to LDAC alone. Patients receiving the combination of Daurismo and LDAC had a median overall survival of 8.3 months, as opposed to 4.3 months for those receiving LDAC alone.

The response rates for patients treated with Daurismo also underscore its efficacy in the treatment of AML. The combination of Daurismo with LDAC resulted in a complete remission (CR) rate of 17% and a CR with partial hematologic recovery (CRh) rate of 19.3%. These results indicate that Daurismo, when used in conjunction with LDAC, can be an effective treatment option for AML patients who are not candidates for intensive chemotherapy, offering a potential improvement in survival outcomes.