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Initial experience with CMC-544 (inotuzumab ozogamicin) in pediatric patients with relapsed B-cell acute
Michael Rytting1, Lisa Triche, Deborah Thomas
1Department of Pediatrics, The University of Texas MD Anderson Cancer Center, Texas; Department of Leukemia, The University of Texas MD Anderson Cancer Center, Texas.
Insights
Inotuzumab ozogamicin (CMC-544) shows promising activity in pediatric patients with relapsed or refractory acute B-cell lymphoblastic leukemia (ALL). The drug was generally well tolerated in this challenging patient population.
Area of Science:
- Pediatric Oncology
- Hematology
- Immunotherapy
Background:
- Pediatric patients with relapsed or refractory acute B-cell lymphoblastic leukemia (ALL) have limited therapeutic options and poor survival rates.
- Inotuzumab ozogamicin (CMC-544) has demonstrated efficacy in adult patients with relapsed and refractory ALL.
Purpose of the Study:
- To evaluate the safety and activity of CMC-544 in pediatric patients with multiply relapsed ALL.
- To assess different dosing schedules of CMC-544 in this patient group.
Main Methods:
- A phase II, non-randomized trial enrolled five pediatric patients (4-15 years) with relapsed, CD22-positive B-cell ALL.
- Patients received CMC-544 at escalating doses (1.3 mg/m², then 1.8 mg/m² every 3 weeks) or a split weekly schedule.
- All patients had refractory relapsed B-cell ALL with high CD22 expression.
Main Results:
- One patient achieved complete remission, and two achieved bone marrow morphologic remission.
- Two patients did not respond to CMC-544 treatment.
- Observed toxicities included fever, sepsis, and elevated liver enzymes, considered manageable in this high-risk population.
Conclusions:
- Single-agent CMC-544 demonstrated promising activity in pediatric patients with relapsed and refractory ALL.
- The drug was generally well tolerated across the tested dosing schedules.
- CMC-544 represents a potential therapeutic option for pediatric B-cell ALL that has relapsed or is refractory to treatment.
Abstract:
Survival is poor in pediatric patients with relapsed or refractory acute B-cell lymphoblastic leukemia (ALL) and therapeutic options are limited. CMC-544 (inotuzumab ozogamicin) has shown significant activity in adult patients with relapsed and refractory ALL. We evaluated CMC-544 in pediatric patients with multiply relapsed ALL. Five children 4-15 years old with relapsed, CD 22 positive B-cell ALL were enrolled on a phase II non-randomized trial of CMC-544. CMC-544 was initially administered at 1.3 mg/m(2) every 3 weeks. The dose then increased to 1.8 mg/m(2) every 3 weeks. Subsequently, a weekly schedule of CMC-544 given as 0.8 mg/m(2) on day 1 followed by 0.5 mg/m(2) on days 8 and 15 was administered. All five patients had refractory relapsed B-cell ALL. Lymphoblasts for all patients highly expressed CD22. Four patients had two or more relapses before starting the study drug. One patient achieved a complete remission in the bone marrow and normal peripheral counts, and two patients achieved bone marrow morphologic remission with absolute neutrophils >1,000/µl but platelets <100,000/µl. Two patients had no response to the drug. Toxicities consisted of fever, sepsis, and liver enzyme elevation. Single agent CMC-544 given at the single dose of 1.8 mg/m(2) every 3 weeks or given as a split, weekly dose was generally well tolerated considering the inherent risks in this population of patients and showed promising activity in pediatric patients with relapsed and refractory ALL.
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