1696P - A randomized, open-label, non-inferiority study comparing the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B-cell non-Hodgkin lymphomas (B-NHL): AVOID neutropenia

Abstract

Background: Lipegfilgrastim (LONQUEX®) has proven to be non-inferior to pegfilgrastim (NEULASTA®) in the reduction of the duration of severe neutropenia (DSN) in breast cancer patients. The efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with B-NHL at high risk for R-CHOP-21-induced neutropenia was investigated. The primary efficacy endpoint was the DSN in cycle 1. Methods: One hundred and one patients with NHL, median age of 74 years, were randomized to receive either 6 mg of lipegfilgrastim or pegfilgrastim per cycle during 6 cycles of R-CHOP-21. Results: Lipegfilgrastim was non-inferior to pegfilgrastim in the DSN in cycle 1: the mean DSN (days) in cycle 1 was 0.8±.96 and 0.9±1.08 in the per-protocol population, respectively with an adjusted mean difference (95% confidence interval) between groups of -0.3 (-0.70, 0.19). The upper boundary was below the predefined non-inferiority margin of 1. Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of febrile neutropenia (FN) in cycle 1 was 2% (1/41) in the lipegfilgrastim and 0% (0/44) in the pegfilgrastim group. The incidence of severe neutropenia in cycle 1 was similar in the lipegfilgrastim (21/41; 51%) and pegfilgrastim (23/44; 52%) groups. The mean time to absolute neutrophil count recovery to a threshold of ≥ 2.0 × 109/L was similar in lipegfilgrastim (8.3 days) and pegfilgrastim (8.7 days) groups. Adverse events (AEs) occurred in 98% of patients; in 45/46 of lipegfilgrastim and 49/50 of the pegfilgrastim group. Serious AEs occurred in 46% of patients; 21/46 in the lipegfilgrastim and 23/50 in pegfilgrastim group; none were assessed as treatment-related by the investigator. Fatal AEs occurred in 4% (2/46) of lipegfilgrastim and 10% (5/50) of the pegfilgrastim group. Study withdrawal due to AEs occurred in 2% (1/46) of the lipegfilgrastim and 18% (9/50) of the pegfilgrastim group. Conclusions: Lipegfilgrastim was non-inferior to pegfilgrastim in the reduction of the DSN in elderly patients with B-NHL. The safety of lipegfilgrastim was comparable to pegfilgrastim. Clinical trial identification: EudraCT: 2013-001284-23. Legal entity responsible for the study: Merckle GmbH (part of Teva Pharmaceuticals group). Funding: Merckle GmbH (part of Teva Pharmaceuticals group). Disclosure: H. Link: Advisory boards, investigator in sponsored trial: Teva. G. Illerhaus, U.M. Martens, A. Salar, R. Depenbusch, A. Kohler, M.M. Engelhardt, S. Mahlmann, M. Zaiss: Investigator in Teva sponsored trial. A. Lammerich, P. Bias, A. Buchner: Employee and stock options: Teva.