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Non-Chemotherapy Sequential Therapy Achieves High Remission Rate Among Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia

June 5, 2023

Mid-July 2023

Anna Azvolinsky, PhD

Anna Azvolinsky, PhD, is a freelance medical and science journalist based in New York City. 

Induction therapy with inotuzumab ozogamicin followed by consolidation with blinatumomab was highly effective and safe in older patients with newly diagnosed, CD22+, Ph-negative B-cell acute lymphoblastic leukemia (B-ALL). Matthew Wieduwilt, MD, PhD, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, presented the results at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2.

The multicenter, single-arm, phase II Alliance A041703 study met its primary endpoint of one-year event-free survival (EFS), demonstrating that the two-drug, non-chemotherapy combination was superior compared to conventional chemotherapy for older patients with newly diagnosed CD22+, Ph-negative B-ALL.

Inotuzumab ozogamicin, an anti-CD22 antibody-drug conjugate, and blinatumomab, an anti-CD3/CD19 bifunctional T-cell engager, were each previously shown to have superior efficacy compared to conventional chemotherapy in phase III clinical trials of patients with relapsed or refractory B-ALL. Both are approved by the U.S. Food and Drug Administration for relapsed B-ALL, yet this is the first clinical trial combining these therapies without the use of any conventional systemic chemotherapy for Ph-negative B-cell patients.

The study included 33 patients age 60 and older with newly diagnosed, CD22+, Ph-negative B-ALL. The median age was 71 (range = 60-84), and 85% of patients identified as white. Fifty-eight percent of patients were male.

Patients received an initial induction with inotuzumab ozogamicin on days one, 8 and 15, followed by a second induction course for those patients who failed to achieve a cytoreduction. Subsequently, patients received a consolidation course of blinatumomab for two cycles of 42 days each and the option for a second two-cycle consolidation course.

Thirty-two of 33 patients (97%) achieved a complete remission (CR), with 20 patients achieving a CR, 11 patients achieving a CR with partial hematologic recovery, and one patient achieving a CR with incomplete count recovery.

At one year, the EFS rate was 75% (90% CI 63-93). The median EFS was not reached at the time of the data lock on January 26, 2023.

The one-year overall survival (OS) was 84% (95% CI 72-98). The median OS was not reached.

Nine patients experienced a relapse event, including two patients who had progression to central nervous system disease and three patients who showed evidence of CD19-negative disease. One patient relapsed with CD22-negative disease. One patient died of refractory ALL, one patient died on study therapy, and a third patient died while in remission and undergoing an allogeneic hematopoietic cell transplant.

Grade 3 or higher toxicity with a frequency of higher than 10% included neutrophil count decrease (87.9%), platelet count decrease (72.7%), anemia (42.4%), white blood cell count decrease (27.3%), febrile neutropenia (21.2%), and encephalopathy (12.1%).

“The results from this study warrant additional trials and the results could help improve outcomes for older patients with B-ALL [and also] outcomes of younger patient to whom this approach could be applied in sequence with conventional chemotherapy,” Dr. Wieduwilt said.

Any conflicts of interest declared by the authors can be found in the publication. Some of the data reported here were updated at the time of presentation and differ from that reported in the abstract.

Reference

Wieduwilt MJ, Yin J, Kour O, et al. Chemotherapy-free treatment with inotuzumab ozogamicin and blinatumomab for older adults with newly diagnosed, Ph-negative, CD22-positive, B-cell acute lymphoblastic leukemia: Alliance A041703. Abstract 7006. Presented at the 2023 American Society of Clinical Oncology, June 2, 2023; Chicago, Illinois.

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