Abstract P134

THE BELIEVE STUDY: EFFECTIVENESS AND SAFETY FOR RE-TREATMENT WITH BRENTUXIMAB-VEDOTIN IN RELAPSED/REFRACTORY (R/R) HODGKIN LYMPHOMA: A RETROSPECTIVE MEDICAL CHART REVIEW IN SPAIN. NCT:04998331

INTRODUCTION: Brentuximab vedotin (BV) is a CD30-directed antibody-drug conjugate. The efficacy and clinical benefit of BV in patients with CD30+ R/R malignancies has been shown in pivotal studies. The aim of this study was to describe effectiveness/safety of BV retreatment in R/R CD30+ patients in Spain.

METHODS: A noninterventional, retrospective chart review was conducted in 30 Spanish sites (collection: 2014-2022). Adult patients with CD30+ malignancies who were treated with BV (evidence of objective response, OR), and having received ≥2 doses of BV as retreatment were included. Patients were followed up to ≥6 months, treatment discontinuation due to death, or toxicity. The primary objectives: to assess the safety and effectiveness of BV retreatment. In this communication we will present the data related to cHL patients.

RESULTS : Of 43 patients included, 16 were cHL. At BV retreatment more than 50% of patients had advanced disease (2 Stage III, and 5 Stage IV). The median age was 36 (18-62) years, 56.2% males, and 90% had ECOG PS, grade 0–1. Most patients, 13 (81.2%), received treatments between the first course of BV and BV retreatment with a median number of lines: 1 (1–5). After the first treatment with BV: 4 patients underwent an autologous transplant, 1 underwent 2 autologous in tandem and 2 patients had an allogenic. After retreatment 4 patients underwent 1 allogenic. ORR was 75%; 68.8% CR, 1 (6.2%) achieved PR and progression was observed in 2 patients (12.5%). Median time to achieve CR: 3 months. The median PFS: 9.6 months (0.5-77.5) and median OS was 33.1 (0.5-50) months. 9 (56%) patients died mainly due to progression (Fig. 1). The median number of cycles during the first treatment with Bv: 4 (2-16) and during retreatment: 4.5 (2-18). Seven (53.8%) experienced adverse events (AEs) related to BV retreatment, mainly peripheral sensory neuropathy. Severe AEs were reported in 2 patients (12.5%), peripheral motor and sensory neuropathy. No Grade 5 events were reported during retreatment.

CONCLUSIONS: The BELIEVE study is the first real word evidence study in Spain that assesses the role of BV as retreatment. Safety results were manageable with dose modification or interruption. BV retreatment seems to be a promising and tolerable treatment alternative for cHL patients.

Authors

Anna Sureda-Balari, Ramón García-Sanz, Eva Domingo-Domènech, Francisco J. Capote, Antonio Gutierrez, Antonia Rodríguez Izquierdo, Marta Grande, Lourdes Baeza-Montañez