Antileukemic efficacy of F16IL2 and BI 836858 combination therapy. (A) Swimmer plot of individual treatment courses and outcome in all 15 patients. Cohort assignment is color coded and AEs, SAEs, or DLTs leading to treatment termination are indicated. Antileukemic activity was mainly observed in the 2 highest DLs. (B) Kaplan-Meier estimates of OS of all 15 patients treated in the study. Median OS was 4.8 (interquartile range, 1.5-12.9) months, with a 6- and 12-month OS of 40% and 27%, respectively. (C) Simon-Makuch estimates of OS by response with a 28-day landmark (end of C1), using response as a time-dependent covariable. Among those 7 patients in whom AML was at least temporarily controlled with study treatment, median OS was 12.0 months (vs 1.2 months in nonresponders), with a 12-month OS of 56% vs 0% (hazard ratio, 0.17; 95% confidence interval, 0.03-0.84; Mantel-Byar test, P = .016). DC, disease control (SD or better).