Drug updated on 9/4/2024
Dosage Form | injectable (intravenous; 0.9 mg/vial) |
Drug Class | CD22-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.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Besponsa (inotuzumab ozogamicin) Prescribing Information. | 2024 | Pfizer Inc., Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of inotuzumab ozogamicin (CMC-544) for the treatment of relapsed/ refractory acute lymphoblastic leukemia and non-Hodgkin lymphoma: a systematic review and meta-analysis. | 2021 | Clinical Lymphoma, Myeloma & Leukemia |
Efficacy of targeted immunotherapy as induction or salvage therapy in acute lymphoblastic leukemia: a systematic review and meta-analysis. | 2021 | Technology in Cancer Research & Treatment |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
BC cancer protocol summary for treatment of relapsed or refractory pre-B cell acute lymphoblastic leukemia with inotuzumab ozogamicin. | 2022 | BC Cancer |
The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia. | 2020 | Journal for ImmunoTherapy of Cancer |
Pediatric acute lymphoblastic leukemia, version 2.2020. | 2020 | Journal of the National Comprehensive Cancer Network |
Princess Margraret Cancer Centre clinical practice guidelines. | 2019 | Princess Margaret Cancer Centre |