PracticeUpdate: Haematology & Oncology

EHA 2016 21

Inotuzumab ozogamicin proves highly effective in older patients with relapsed/ refractory acute lymphoblastic leukaemia Inotuzumab ozogamicin has

E lias J Jabbour, MD, of the University of Texas MDAnderson Cancer Center, Houston, explained that inotuzumab ozogamicin, an anti-CD22 antibody- calicheamicin conjugate, has demonstrated superior response versus standard care for relapsed/refractory acute lymphoblastic leukaemia in the ongoing phase 3 INO-VATE trial (complete remission/complete remission with incomplete haematologic recovery, 81% [95% CI 72–88%]; minimal residual disease negativity in responders, 78% [68–87%]; median remission duration, 4.6 [3.9–5.4] months). Dr Jabbour and colleagues set out to assess the efficacy and safety of inotuzumab ozogamicin in patients with relapsed/refractory acute lymphoblastic leukaemia age younger than 55 versus 55 years of age and older. Per protocol, the intent-to-treat analyses of complete response/complete response with incomplete haematologic recovery included the first 218 of 326 patients randomised (ITT 218).

Responses and safety profiles were similar to those of younger patients and the overall study population.

been proven highly effective in older patients with relapsed/ refractory acute lymphoblastic leukaemia for whom treatment options are limited, reports the global, phase 3, randomised, controlled INO-VATE trial.

The safety population included 139 patients who received at least one inotuzumab ozogamicin dose (maximum 1.8 mg/m 2 per cycle [0.8 mg/m 2 on day 1; 0.5 mg/m 2 on days 8 and 15 of a 21–28 day cycle for six cycles or less]). Minimal residual disease negativity was assessed by central flow cytometry (<0.01%). Data as of 2014 were presented, as the trial is ongoing. One hundred and nine patients in the ITT 218 received inotuzumab ozogamicin (median age 47 [range, 18–78] years; patients ≥ 55 years of age, 43 [39%]). Remission rates and duration of response were similar, whereas minimal residual disease-negativity rates in responders were numerically higher in older patients. In the safety population, grade ≥ 3 adverse events were most frequently cytopenias (neutropenia, 46%; thrombocytopenia, 37%; febrile neutropenia, 24%). These grade ≥ 3 adverse events were more common in patients ≥ 55 (n=53) versus <55 years (n=86) of age: thrombocytopenia (49% vs 29%), neutropenia (53% vs 42%), febrile neutropenia (28% vs 21%). Patients ≥ 55 versus <55 years of age discontinued due to adverse events at similar rates (both 17%). For patients ≥ 55 versus <55 years of age, any-grade hepatobiliary adverse event rates were similar (both 26%) and included, hyperbilirubinemia (both 15%), and veno- occlusive liver disease including post stem cell transplant veno-occlusive disease (both 11%; two fatal in patients <55 years of age [one after second stem cell transplant]). Dr Jabbour concluded that inotuzumab ozogamicin was proven to be highly effective in older patients with relapsed/refractory acute lymphoblastic leukaemia for whom treatment options are limited. Responses and safety profiles were similar to those of younger patients and the overall study population.

DECEMBER 2016