Efficacy and safety of inotuzumab ozogamicin (InO) in older patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) enrolled in the phase 3 INO-VATE trial.

Abstract

7029Background: InO, an anti-CD22 antibody-calicheamicin conjugate, has demonstrated superior response vs standard care for R/R ALL in the phase 3 INO-VATE trial (complete remission [CR]/CR with incomplete hematologic recovery [CRi], 81% [95% CI; 72–88]; minimal residual disease [MRD] negativity in responders, 78% [68–87]; median remission duration [DoR], 4.6 [3.9–5.4] mo). Herein, the efficacy and safety of InO in patients (pts) aged ≥55 vs <55 y are assessed. Methods: Per protocol, the intent-to-treat analyses of CR/CRi included the first 218 of 326 pts randomized (ITT218). The safety population included 139 pts who received ≥1 InO dose (max 1.8 mg/m2/cycle [0.8 mg/m2 on d1; 0.5 mg/m2on d8 and 15 of a 21–28 d cycle for ≤6 cycles]). MRD negativity was assessed by central flow cytometry (<0.01%). Data as of October 2, 2014 are presented (trial ongoing). Results: 109 pts in the ITT218 received InO (median age, 47 [range, 18–78] y; pts ≥55 y, 43 [39%]). Remission rates and DoR were similar whereas MRD-negat...