^
Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Title:

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

Published date:
03/06/2024
Excerpt:
...the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Evidence Level:
Sensitive: A1 - Approval
Title:

BESPONSA APPROVED BY HEALTH CANADA FOR THE TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA

Published date:
04/06/2018
Excerpt:
Pfizer Canada announced today that Health Canada has approved BESPONSA (inotuzumab ozogamicin for injection) as a monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Evidence Level:
Sensitive: A1 - Approval
Published date:
06/28/2017
Excerpt:
Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

Excerpt:
...- Patients must have a confirmed diagnosis of CD22-positive, Philadelphia chromosome (Ph)-positive or Ph-negative B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

Excerpt:
...Relapsed or refractory precursor CD22 positive B cell ALL with M2 or M3 marrow (≥5% blasts) and who are eligible for HSCT; 2....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

Excerpt:
...Diagnosed with CD-22 positive* B-cell Acute Lymphoblastic Leukemia or B-cell Lymphoblastic Lymphoma (Philadelphia chromosome negative) * For the purposes of this study, CD-22 positive will be defined based on the analysis completed for diagnostic purposes....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

Excerpt:
...- Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

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

Excerpt:
...- Must be CD22 positive by local assessment (>= 20% by immunohistochemistry or flow cytometry)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Excerpt:
...- Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase I trial of dose-adjusted EPOCH plus inotuzumab ozogamicin (InO) in adults with relapsed/refractory (R/R) B lymphoblastic leukemia/lymphoma (B-ALL).

Published date:
05/25/2023
Excerpt:
Eligible patients (pts) were adults with R/R CD22+ B-ALL...In the pts with ≥5% blood/BM blasts (n=20), the CR/CRi rate was 85%....With median follow-up of 12 months (m), the median overall and relapse-free survival were 19 m and 12 m….The addition of InO to DA-EPOCH in adults with heavily-pretreated R/R B-ALL is safe, with ITT response rates among the highest reported to date.
Secondary therapy:
EPOCH
DOI:
10.1200/JCO.2023.41.16_suppl.7007
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Phase II Trial of Inotuzumab Ozogamicin in Children and Adolescents With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: Children's Oncology Group Protocol AALL1621

Published date:
01/10/2022
Excerpt:
This single-arm phase II trial enrolled patients age 1-21 years with R/R CD22-positive B-ALL…Forty-eight patients were evaluable for response and toxicity; 19 had complete response (CR)…InO is effective and well tolerated in heavily pretreated children and adolescents with R/R CD22-positive B-ALL.
DOI:
10.1200/JCO.21.01693
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Fractionated Inotuzumab Ozogamicin Combined with Low-Intensity Chemotherapy Provides Very Good Outcome in Older Patients with Newly Diagnosed CD22+ Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia: First Results from the EWALL-INO Study

Published date:
11/04/2021
Excerpt:
Here, we aimed to assess the activity and safety of fractionated INO at a reduced dosage in combination with low-intensity chemotherapy as frontline therapy for older pts with CD22+ Philadelphia chromosome-negative (Ph-neg) BCP-ALL. One-year OS was estimated to be 78.5% (95%CI 68-85.9) and median OS was not reached. One-year relapse free survival was 74.5% (95CI 63.5-82.6). Fractionated inotuzumab ozogamicin at reduced doses (0.8/0.5/0.5/0.5 mg/m²) combined with low-intensity chemotherapy is a very active and well tolerated frontline therapy for older patients with CD22+ Ph-neg BCP-ALL.
DOI:
10.1182/blood-2021-148625
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Outcome after Inotuzumab Ozogamicin for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia and Extramedullary Disease

Published date:
11/04/2021
Excerpt:
We studied 31 r/r pts (median age, 31 years; range, 19-81 years), who were treated with InO between 2015 and 2021…. All pts were CD22 positive at relapse/progressive disease….Complete remission assessed by PET-CT (CR; including EM and hematological/bone marrow CR) after the first InO cycle was achieved in 10 of 24 assessed pts (42%), 9 pts (37.5%) had a partial remission (PR), 2 (8%) had stable disease (SD) and 3 (12.5%) showed resistant/progressive disease (RD/PD). After 2 InO cycles, CR was achieved in 17 of 31 pts (55%), PR in 9 (29%).
DOI:
10.1182/blood-2021-147446
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

OUTCOME OF RELAPSED OR REFRACTORY ACUTE B-LYMPHOBLASTIC LEUKEMIA PATIENTS WITH EXTRAMEDULLARY DISEASE RECEIVING INOTUZUMAB OZOGAMICIN

Published date:
05/12/2021
Excerpt:
...relapsed/refractory (r/r) adult EM-ALL patients (pts) and evaluate outcome after InO treatment....All 17 pts were CD22 positive at relapse/progressive disease….One-year and two-years OS rates were 50% (95%>CI, 25-71%) and 23% (95%>CI, 6-46%), respectively....This outcome analysis demonstrates that treatment with InO is an effective and promising approach...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy and Safety by Baseline CD22

Published date:
02/18/2021
Excerpt:
Adults with relapsed/refractory B-cell precursor CD22-positive (by local or central laboratory) acute lymphoblastic leukemia were randomized to InO...The response rate was significantly higher with InO versus SC. Minimal residual disease negativity, duration of remission (DoR), progression-free survival, and overall survival (OS) were significantly better with InO versus SC in patients with CD22 positivity {greater than or equal to}90%.
DOI:
10.1158/1078-0432.CCR-20-2399
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study

Excerpt:
Median progression-free survival was 3.9 (95% confidence interval, 2.9-5.4) months; median overall survival was 7.4 (5.7-9.2) months for all treated patients...InO was well tolerated and demonstrated high single-agent activity…
DOI:
10.1182/bloodadvances.2016001925
Trial ID:
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Combining Inotuzumab Ozogamicin (IO) with PARP Inhibitors, Olaparib and Talazoparib, Exerts Synergistic Cytotoxicity By Inhibiting the Repair of IO-Induced DNA Strand Breaks in IO-Resistant ALL Cells

Published date:
11/02/2023
Excerpt:
Ph-negative, CD22-positive B-ALL Reh cell line was used to determine the cytotoxicity of IO and PARP inhibitors….The combination of IO with PARP inhibitors synergized the antileukemic effect of IO by inhibiting DNA strand break repair in CD22-positive ALL cell lines and IO-resistant ALL cells...
Secondary therapy:
PARP inhibitor
DOI:
https://doi.org/10.1182/blood-2023-173907