O’Connor OA, et al. - Researchers tested alisertib, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) in this open-label, first-in-setting, randomized phase III trial. Oral alisertib 50 mg two times per day (days 1 to 7; 21-day cycle) or investigator-selected single-agent comparator, including intravenous pralatrexate 30 mg/m² (once per week for 6 weeks; 7-week cycle), or intravenous gemcitabine 1,000 mg/m² or intravenous romidepsin 14 mg/m² (days 1, 8, and 15; 28-day cycle) was randomly administered 1:1 to 271 adult patients with relapsed/refractory PTCL—one or more prior therapy; alisertib, n = 138; comparator, n = 133. Median progression-free survival (PFS) was 115 days for alisertib and 104 days for the comparator arm. For alisertib and for the comparator arm, median PFS was 115 days and 104 days and centrally assessed overall response rate was 33% and 45%, respectively. Anemia (53% of alisertib-treated patients v 34% of comparator-treated patients) and neutropenia (47% v 31%, respectively) were reported as the most commonly detected adverse events. Overall, alisertib showed no statistically significant superiority to the comparator arm in patients with relapsed/refractory PTCL.