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Inotuzumab ozogamicin (INO)
Inotuzumab ozogamicin is an anti-CD22 monoclonal antibody conjugated to a cytotoxic calicheamicin payload that binds to CD22 on B-cell lymphomas and delivers cell-killing toxin directly to tumor cells.
Inotuzumab ozogamicin is an anti-CD22 monoclonal antibody conjugated to a cytotoxic calicheamicin payload that binds to CD22 on B-cell lymphomas and delivers cell-killing toxin directly to tumor cells. Used for Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), Relapsed or refractory B-cell non-Hodgkin lymphoma.
At a glance
| Generic name | Inotuzumab ozogamicin (INO) |
|---|---|
| Also known as | InO vs. R3 randomisation in SR |
| Sponsor | Charite University, Berlin, Germany |
| Drug class | Antibody-drug conjugate (ADC) |
| Target | CD22 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
The drug targets CD22, a surface antigen expressed on B-lineage hematologic malignancies. Upon binding, the antibody-drug conjugate is internalized and releases calicheamicin, which causes DNA double-strand breaks and apoptosis. This targeted delivery mechanism concentrates cytotoxicity on malignant B cells while sparing normal tissues.
Approved indications
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
- Relapsed or refractory B-cell non-Hodgkin lymphoma
Common side effects
- Thrombocytopenia
- Neutropenia
- Anemia
- Infection
- Nausea
- Vomiting
- Hepatotoxicity
- Sinusoidal obstruction syndrome (SOS)
Key clinical trials
- A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (PHASE3)
- Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL (PHASE2)
- Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy (PHASE2)
- A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL (PHASE2)
- International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) (PHASE3)
- Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL (PHASE2)
- Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia (PHASE2)
- Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Inotuzumab ozogamicin (INO) CI brief — competitive landscape report
- Inotuzumab ozogamicin (INO) updates RSS · CI watch RSS
- Charite University, Berlin, Germany portfolio CI