PILLAR-2: A randomized, double-blind, placebo-controlled, phase III study of adjuvant everolimus (EVE) in patients (pts) with poor-risk diffuse large B-cell lymphoma (DLBCL).

7506Background: The goal of PILLAR-2 (NCT00790036) was to reduce DLBCL relapse by providing 1 year of adjuvant EVE to poor-risk (International Prognostic Index [IPI] ≥3) pts who had achieved a CR with R-chemo. Methods: PILLAR-2 was a multicenter double-blind, placebo (PBO)-controlled, phase 3 study. Pts with histologically confirmed stage III/IV poor-risk (IPI ≥3) DLBLC who had a PET/CT-confirmed CR to first-line R-chemo were randomized 1:1 to EVE 10 mg/day or PBO for 1 year or until disease relapse, unacceptable toxicity, or death. The primary endpoint was disease-free survival (DFS) by local assessment using revised IWRC; secondary endpoints were overall survival (OS), lymphoma-specific survival (LSS), and safety. Results: Median study follow-up was 50.4 months (range, 24.0–76.9 months). Of the 742 pts randomized, 177 (48%) pts in the EVE and 249 (67%) in the PBO arms completed the study treatment as per protocol. Overall, 47% pts were ≥65 years, 50% were male and 42% had an IPI of 4+5. Adjuvant EVE did...