Inotuzumab Ozogamicin
drug drugOn this page
Also known as BesponsaCMC-544Inotuzumab ozogamicinaInotuzumab ozogamicinePF-05208773WAY-207294WAY-207294 CMC-544
Summary
Inotuzumab Ozogamicin (CHEMBL2108611) is an approved antibody drug conjugate (ATC L01FB01) targeting CD22; indicated across 16 conditions including acute lymphoblastic leukemia and neoplasm.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody drug conjugate
- ATC class: L01FB01
- Targets: 1 (CD22)
- Indications: 16 conditions
- Clinical trials: 52
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2108611 |
| Name | Inotuzumab Ozogamicin |
| Type | Antibody drug conjugate |
| Max phase | 4 |
| ATC | L01FB01 |
Also known as: Besponsa, CMC-544, Inotuzumab ozogamicin, Inotuzumab ozogamicina, Inotuzumab ozogamicine, PF-05208773, WAY-207294, WAY-207294 CMC-544, INOTUZUMAB OZOGAMICIN
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| CD22 | CD22 | Binding | 9.7 | 0.2% | P20273 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): CD22.
Top Reactome pathways
6 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Adaptive Immune System | 1 | CD22 |
| Immune System | 1 | CD22 |
| Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell | 1 | CD22 |
| CD22 mediated BCR regulation | 1 | CD22 |
| Antigen activates B Cell Receptor (BCR) leading to generation of second messengers | 1 | CD22 |
| Signaling by the B Cell Receptor (BCR) | 1 | CD22 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| negative regulation of immunoglobulin production | 1 |
| cell adhesion | 1 |
| regulation of endocytosis | 1 |
| regulation of B cell proliferation | 1 |
| B cell activation | 1 |
| regulation of immune response | 1 |
| negative regulation of calcium-mediated signaling | 1 |
| negative regulation of B cell receptor signaling pathway | 1 |
| negative regulation of immune system process | 1 |
| negative regulation of signal transduction | 1 |
Indications & clinical
Indications
7 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).
| Indication | Phase | MONDO | EFO |
|---|---|---|---|
| acute lymphoblastic leukemia | 4 | MONDO:0004967 | EFO:0000220 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| B-cell acute lymphoblastic leukemia | 4 | MONDO:0004947 | EFO:0000094 |
| lymphoid leukemia | 4 | MONDO:0005402 | EFO:0004289 |
| neoplasm of mature B-cells | 3 | MONDO:0004949 | EFO:0000096 |
| non-Hodgkin lymphoma | 3 | MONDO:0018908 | EFO:0005952 |
| follicular lymphoma | 3 | MONDO:0018906 | MONDO:0018906 |
8 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| hematopoietic and lymphoid system neoplasm | 2 | MONDO:0002334 | MONDO:0044881 |
| leukemia | 2 | MONDO:0005059 | EFO:0000565 |
| lymphoid neoplasm | 2 | MONDO:0005157 | EFO:0001642 |
| blast phase chronic myelogenous leukemia, BCR-ABL1 positive | 1 | MONDO:0006115 | EFO:1000131 |
| Burkitt lymphoma | 1 | MONDO:0007243 | EFO:0000309 |
| chronic myeloid leukemia | 1 | MONDO:0011996 | EFO:0000339 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 52.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 23 |
| PHASE1 | 9 |
| PHASE1/PHASE2 | 8 |
| PHASE3 | 6 |
| Not specified | 5 |
| PHASE4 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05687032 | PHASE4 | COMPLETED | A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia |
| NCT03150693 | PHASE3 | RECRUITING | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT03959085 | PHASE3 | RECRUITING | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT04307576 | PHASE3 | RECRUITING | A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia |
| NCT00562965 | PHASE3 | TERMINATED | Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator’s Choice In Follicular Non-Hodgkin’s Lymphoma (NHL) |
| NCT01232556 | PHASE3 | TERMINATED | A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy |
| NCT01564784 | PHASE3 | COMPLETED | A Study Of Inotuzumab Ozogamicin Versus Investigator’s Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia |
| NCT01371630 | PHASE1/PHASE2 | RECRUITING | Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT02877303 | PHASE2 | RECRUITING | Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT02981628 | PHASE2 | RECRUITING | Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia |
| NCT03104491 | PHASE1/PHASE2 | RECRUITING | Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia |
| NCT03441061 | PHASE2 | ACTIVE_NOT_RECRUITING | Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease |
| NCT03739814 | PHASE2 | RECRUITING | Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia |
| NCT05303792 | PHASE2 | ACTIVE_NOT_RECRUITING | Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma |
| NCT05456698 | PHASE2 | ACTIVE_NOT_RECRUITING | Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy |
| NCT05645718 | PHASE2 | RECRUITING | Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia |
| NCT05748171 | PHASE2 | RECRUITING | A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL |
| NCT05940961 | PHASE2 | RECRUITING | Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL |
| NCT06287229 | PHASE1/PHASE2 | RECRUITING | Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab |
| NCT06387121 | PHASE2 | RECRUITING | Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL |
| NCT06427330 | PHASE2 | RECRUITING | Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia |
| NCT06554626 | PHASE2 | RECRUITING | Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL |
| NCT06985485 | PHASE2 | RECRUITING | Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy |
| NCT00299494 | PHASE1/PHASE2 | COMPLETED | Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin’s Lymphoma (NHL) |
| NCT00867087 | PHASE2 | COMPLETED | Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin’s Lymphoma |
| NCT00868608 | PHASE2 | COMPLETED | Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma |
| NCT01363297 | PHASE2 | COMPLETED | Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia |
| NCT01664910 | PHASE1/PHASE2 | COMPLETED | CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies |
| NCT01679119 | PHASE2 | COMPLETED | Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy |
| NCT02311998 | PHASE1/PHASE2 | COMPLETED | Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML |
| NCT03094611 | PHASE2 | TERMINATED | Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia |
| NCT03460522 | PHASE2 | UNKNOWN | Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL |
| NCT03488225 | PHASE2 | TERMINATED | Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT03851081 | PHASE1/PHASE2 | WITHDRAWN | Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia |
| NCT03856216 | PHASE2 | TERMINATED | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation |
| NCT03913559 | PHASE2 | TERMINATED | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT04747912 | PHASE2 | SUSPENDED | Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) |
| NCT06087419 | PHASE1/PHASE2 | UNKNOWN | A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Venetoclax in RR Ph-ALL and B-cell Lymphoma Patients |
| NCT03962465 | PHASE1 | ACTIVE_NOT_RECRUITING | Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL |
| NCT05016947 | PHASE1 | ACTIVE_NOT_RECRUITING | Venetoclax Plus Inotuzumab for B-ALL |
| NCT00073749 | PHASE1 | COMPLETED | Study Evaluating CMC-544 In B-Cell Non-Hodgkin’s Lymphoma |
| NCT00717925 | PHASE1 | COMPLETED | Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin’s Lymphoma (NHL) |
| NCT00724971 | PHASE1 | COMPLETED | Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab |
| NCT01055496 | PHASE1 | COMPLETED | Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin’s Lymphoma |
| NCT01535989 | PHASE1 | COMPLETED | Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma |
| NCT01925131 | PHASE1 | COMPLETED | S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia |
| NCT03991884 | PHASE1 | COMPLETED | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia |
| NCT07238907 | Not specified | ACTIVE_NOT_RECRUITING | A Multi-center Retrospective Study of INO Treating B-ALL |
| NCT03127605 | Not specified | APPROVED_FOR_MARKETING | Inotuzumab Ozogamicin - PF-05208773 |
| NCT04307134 | Not specified | COMPLETED | Besponsa Post Marketing Surveillance Study |
| NCT04456959 | Not specified | COMPLETED | InO - A Retrospective Study of UK Patients With Leukaemia |
| NCT05597085 | Not specified | COMPLETED | A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Genes: CD22
- Indicated for: acute lymphoblastic leukemia, neoplasm, B-cell acute lymphoblastic leukemia, lymphoid leukemia, neoplasm of mature B-cells, non-Hodgkin lymphoma, follicular lymphoma
- In clinical trials for: lymphoma, diffuse large B-cell lymphoma, hematopoietic and lymphoid system neoplasm, leukemia, lymphoid neoplasm