A clinical trial assessing the use of inotuzumab ozogamicin in patients with acute lymphoblastic leukemia (ALL) has found that it may be a more effective treatment option than current standard practice.
Inotuzumab ozogamicin works by linking an antibody to CD22, a protein found on the surface of more than 90% of ALL cells. Once the drug links with this protein, the ALL cell draws it inside and dies.
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In a clinical trial led by Hagop Kantarjian, MD, University of Texas MD Anderson Cancer Center (Houston, TX), investigators randomly assigned patients with relapsed or refractory ALL to receive either inotuzumab ozogamicin or standard intensive chemotherapy. The primary endpoints of the study were complete remission and overall survival.
Of the 326 patients who underwent randomization, the first 218 were included in the primary intention-to-treat analysis of complete remission. In these patients, the rate of complete remission was found to be significantly higher in the inotuzumab ozogamicin group than in the standard-therapy group (80.7% vs 29.4%, respectively). In addition, 78.4% of patients who had complete remission in the inotuzumab ozogamicin group had results that were below the threshold for minimal residual disease, compared with 28.1% in the standard therapy group. Duration of response was also more than a month longer in those who were treated with inotuzumab ozogamicin than patients who received standard therapy (median 4.6 months vs 3.1 months, respectively).
In the survival analysis, which included all 326 patients, patients receiving inotuzumab ozogamicin again fared significantly better than those in the standard-therapy group, where median progression-free survival was 5 months and 1.8 months, respectively, and median overall survival was 7.7 months and 6.7 months, respectively.
Investigators concluded that treatment with inotuzumab ozogamicin for ALL produced significantly higher rates of complete remission and improved survival when compared with standard therapy.
“Relapsed or refractory ALL is an aggressive leukemia in urgent need of new treatment options as about half of adult patients will not respond to chemotherapy or will see their disease return,” said Dr Kantarjian. “The efficacy results seen in patients treated with inotuzumab ozogamicin in this study are impressive, particularly median progression-free survival, high rates of hematological remission and absence of minimal residual disease.”
He added that, if approved, inotuzumab ozogamicin could be a valuable new option for patients with ALL that acts as a bridge to stem cell transplantation, which offers the best chance for a cure at this stage of the disease.
