Efficacy

Besponsa (Inotuzumab Ozogamicin) Efficacy in Leukemia

Besponsa, also known by its generic name inotuzumab ozogamicin, is an antibody-drug conjugate specifically approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The efficacy of Besponsa was demonstrated in a key phase 3 clinical trial, known as INO-VATE ALL. In this study, patients treated with Besponsa had a higher rate of complete remission (CR) compared to those who received standard chemotherapy. The CR rates with Besponsa were approximately 80.7%, with 29.4% of patients achieving complete remission with partial hematologic recovery. This is a significant improvement over the standard therapy CR rates, which were about 29.4%.

Furthermore, patients treated with Besponsa showed a longer median progression-free survival (PFS) compared to those on standard therapy. The median PFS for patients receiving Besponsa was 5.0 months versus 1.8 months for those receiving standard chemotherapy. Additionally, Besponsa has shown potential in improving overall survival, although the results were not statistically significant in all studies.

Xospata (Gilteritinib) Efficacy in Leukemia

Xospata, or gilteritinib, is an oral medication approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved test. The efficacy of Xospata was evaluated in a clinical trial of patients with relapsed or refractory AML with an FLT3 mutation. In this trial, gilteritinib demonstrated a combined complete remission (CR) and complete remission with partial hematologic recovery (CRh) rate of 21%. This result indicates that a significant portion of patients responded to the treatment.

Moreover, for patients treated with Xospata, the median duration of CR/CRh was 4.6 months, and the median time to first response was 3.6 months. These outcomes suggest that Xospata can induce remissions that are of a clinically meaningful duration. Additionally, in a subsequent analysis, gilteritinib showed an overall survival benefit when compared to salvage chemotherapy, offering a potential new standard of care for patients with FLT3 mutated AML who have relapsed or are refractory to prior treatments.