Efficacy

Besponsa (Inotuzumab Ozogamicin) Efficacy in Leukemia

Besponsa, generically known as inotuzumab ozogamicin, is a monoclonal antibody drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The efficacy of Besponsa was primarily demonstrated in a key phase 3 clinical trial (INO-VATE ALL), which showed a higher complete remission (CR) rate in patients treated with Besponsa compared to standard chemotherapy. Patients receiving Besponsa had a CR rate of 80.7%, significantly higher than the 29.4% observed in the control arm. Furthermore, Besponsa demonstrated a higher rate of minimal residual disease (MRD) negativity among responders, indicating a deeper remission.

The median progression-free survival (PFS) was also notably improved with Besponsa treatment, with patients experiencing a median PFS of 5.0 months compared to 1.8 months in the standard therapy group. Additionally, the median overall survival (OS) was extended for patients treated with Besponsa, although the improvement in OS did not reach statistical significance in all analyses. The results from the INO-VATE ALL study provided strong evidence for the efficacy of Besponsa in the targeted patient population with relapsed or refractory B-cell precursor ALL.

Inqovi (Decitabine and Cedazuridine) Efficacy in Leukemia

Inqovi, a combination of decitabine and cedazuridine, is approved for the treatment of adults with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with various French-American-British (FAB) classifications, and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups. MDS can be a precursor to acute myeloid leukemia (AML), and thus Inqovi is also indicated for the treatment of chronic myelomonocytic leukemia (CMML). The efficacy of Inqovi was established in two open-label, randomized, crossover trials, which demonstrated that the oral combination of decitabine and cedazuridine is bioequivalent to the intravenous formulation of decitabine alone.

Clinical trial results showed that Inqovi provided hematologic improvement and transfusion independence in a significant proportion of patients with MDS and CMML. For instance, in these trials, around 18% to 21% of patients achieved complete remission (CR), and approximately 30% to 37% of patients achieved hematologic improvement. Moreover, the median duration of CR was reported to be 7.5 to 8.7 months. These outcomes suggest that Inqovi is an effective oral treatment option for patients with MDS and CMML, potentially offering a more convenient administration route compared to traditional intravenous therapies.