...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).

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).

Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).

...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....

...Relapsed or refractory precursor CD22 positive B cell ALL with M2 or M3 marrow (≥5% blasts) and who are eligible for HSCT; 2....

...- Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible....

...- Must be CD22 positive by local assessment (>= 20% by immunohistochemistry or flow cytometry)....

...- Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive...

...- Patients must have a confirmed diagnosis of CD22-positive, Philadelphia chromosome (Ph)-positive or Ph-negative B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma....

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.

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.

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.

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%).

...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...

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%.

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…

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...