BRENTUXIMAB VEDOTIN AS CONSOLIDATION TREATMENT IN PATIENTS WITH STAGE I/II CLASSICAL HODGKIN'S LYMPHOMA AND A POSITIVE FDG‐PET AFTER 2 CYCLES OF ABVD: A LYSA PHASE 2 STUDY

Brentuximab vedotin (BV) as consolidation treatment in patients with stage I/II classical Hodgkin's lymphoma and a positive FDG-PET after 2 cycles (PET-2) of ABVD: LYSA phase study. Introduction: Early-stage Hodgkin (cHL) is highly curable chemotherapy radiotherapy (RT). However, interim PET-2 have poorer prognosis require intensification. Indeed, the H10 trial (André et al., 2017) showed that escalated BEACOPP (BEACOPPesc) plus RT improves 5-year PFS treated ABVD. The main objective present study (NCT02298283) was to investigate benefit newly diagnosed early HL insufficient response according TEP cycles. Patients methods: BRAPP2 multicentric, open-label, single arm II trial. All aged from 18 65 years, an Ann Arbor clinical I or cHL, Deauville score 4 & 5 courses ABVD without progressive disease were eligible for After inclusion, received BEACOPPesc (so-called induction) followed unless progression, by 30 Gy IFRT then BV consolidation. (1.8 mg/kg) started at least weeks up 6 given every 3 8 designed detect improvement years 70% (null hypothesis) 85% (alternative assuming 80% power 2-sided alpha (type error) 5%. Results: From 04/2015 04/2018, 48 included whom 41 (efficacy safety set), 35 full (Figure 1). A total 56 adverse events (AEs) reported during 26 (63.4%). Most frequent AEs neurological 12 (29.3%) having experienced grade ≥2 peripheral neuropathy, all related leading discontinuation cases. Febrile neutropenia occurred 12.2% patients, induction period. No fatal reported. According Cheson 2007 criteria, 34 (87.2%, 95%CI [72.6%; 95.7%]) achieved CR, evaluated complete patients. With median follow-up duration 3.1 (95%CI = [2.6; 3.3]), out (9.8%) progressed. 2-year 90.0% [75.5%; 96.1%]). One patient died, due progression (aggressive B-cell lymphoma). OS 97.5% [83.5%; 99.6%]). statistical design, null hypothesis rejected. Keywords: lymphoma, Therapeutics Clinical Trials Lymphoma - Other Conflicts interests pertinent abstract T. Gastinne Consultant advisory role: Gilead, Janssen, Takeda Educational grants: Roche