Efficacy

OS

In AML-19, single-agent MYLOTARG demonstrated statistically superior OS in older patients with newly diagnosed AML ineligible for intensive chemotherapy1,2
31% reduction in the risk of death with single-agent MYLOTARG vs best supportive care (BSC)
  • Among patients achieving CR/CRi, median OS from best response was 8.2 months (95% CI, 5.4-12.8)
AML=acute myeloid leukemia; BSC=best supportive care; CI=confidence interval; OS=overall survival; HR=hazard ratio.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.
2. Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: results of the randomized phase III EORTC-GIMEMA AML-19 trial. J Clin Oncol. 2016;34(9):972-979.

CR/CRi

27% of patients achieved best overall CR/CRi with single-agent MYLOTARG1,2
Response rates among 111 patients in the MYLOTARG arm
Overall Response Rate AML-19
  • The median time to CR/CRi was 36.5 days (range, 14-139 days)
  • Median disease-free survival (DFS), a secondary endpoint, was 5.3 months (95% CI, 3.1-8.0) with MYLOTARG
CI=confidence interval; CR=complete remission; CRi=CR with incomplete recovery of peripheral blood counts; PR=partial response; SD=stable disease.
*Lasting >30 days.
Deaths attributed to induction-associated adverse events.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.
2. Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: results of the randomized phase III EORTC-GIMEMA AML-19 trial. J Clin Oncol. 2016;34(9):972-979.