Inotuzumab ozogamicin

(Besponsa®)

Besponsa®

Drug updated on 9/4/2024

Dosage Forminjectable (intravenous; 0.9 mg/vial)
Drug ClassCD22-directed antibody drug conjugates
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.

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Summary
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  • Besponsa (inotuzumab ozogamicin) is indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
  • This summary is based on the review of two systematic reviews/meta-analyses. [1-2]
  • The complete remission (CR) rate for relapsed/refractory acute lymphoblastic leukemia (ALL) patients treated with inotuzumab ozogamicin (INO) was 67% (95% CI, 61%-73%), with a minimal residual disease (MRD) response rate of 45% (95% CI, 37%-53%).
  • In patients with non-Hodgkin lymphoma (NHL) treated with INO, the pooled CR rate was 28% (95% CI, 15%-47%).
  • Compared to conventional chemotherapy, CD-targeted immunotherapy for ALL showed higher overall survival (OS) and relapse-free survival (RFS) rates, with pooled odds ratios of 2.11 (95% CI, 1.76-2.53) and 2.25 (95% CI, 1.62-3.14), respectively, alongside improved CR and MRD negativity rates.
  • The incidence of hepatic venous obstructive disease/sinus obstructive syndrome in patients receiving inotuzumab ozogamicin (INO) was 8% (95% CI, 5%-14%).
  • The incidence of grade ≥3 hematologic adverse events in patients treated with INO included 29% (95% CI, 20%-39%) for thrombocytopenia and 48% (95% CI, 38%-57%) for neutropenia.
  • CD-targeted immunotherapy was associated with a lower risk of febrile neutropenia compared to conventional chemotherapy (pooled OR, 0.22; 95% CI, 0.08-0.58).
  • There is no population type or subgroup information available in the reviewed studies.