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Inotuzumab Ozogamicin Increases Time to Subsequent Salvage Therapy in ALL: INO-VATE Trial
Findings from the phase 3 INO-VATE trial reveal patients with relapsed/refractory acute lymphoblastic leukemia (ALL) who received inotuzumab ozogamicin were less likely to receive subsequent salvage therapy and experienced a longer time to first subsequent salvage therapy than those who received standard chemotherapy.
The phase 3 trial enrolled 326 adults with CD22-positive relapsed/refractory ALL. Patients were randomized in a 1:1 ratio to receive either inotuzumab ozogamicin (n = 164) or standard chemotherapy (n = 162). The aim of the trial was to compare the time from randomization to first subsequent salvage therapy in each of the treatment arms. Researchers also compared time to salvage therapy in subgroups based on transplantation status and baseline characteristics.
In the inotuzumab ozogamicin arm, 56 (34.1%) patients received subsequent salvage therapy vs 92 (56.8%) in the standard chemotherapy arm. Median time to subsequent salvage therapy was 19 months vs 4 months, respectively (hazard ratio, 0.34; P <.0001).
In addition, inotuzumab ozogamicin was associated with similar benefits vs standard chemotherapy regardless of transplantation status, age, salvage phase, first remission duration, Philadelphia chromosome status, or CD22 expression.
“Patients in the [inotuzumab ozogamicin] versus [standard of care] arm were less likely to receive subsequent salvage therapy, and showed a clinically meaningful extension of [time to subsequent salvage therapy] irrespective of subgroup,” concluded study authors.
“This suggests InO treatment leads to improved outcomes by increasing the likelihood that subsequent salvage therapies and their associated adverse impacts can be delayed or avoided,” they added.
Source:
Stelljes M, Advani AS, DeAngelo DJ, et al. Time to first subsequent salvage therapy in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE Trial. Clin Lymphoma Myeloma Leuk. Published online April 27, 2022. doi:10.1016/j.clml.2022.04.022
