Abstract Introduction: Brentuximab vedotin (BV), a CD30-specific antibody-drug conjugate (ADC), is approved for the treatment of previously untreated advanced-stage and relapse/refractory(R/R) classical Hodgkin lymphoma (cHL). While clinical trials, including ECHELON-1 and SGN35-003, have demonstrated significantly improved outcomes with BV in both frontline and salvage treatment settings, data in Asian populations or real-world (RW) settings are limited. This study evaluated the safety profile and effectiveness of BV in Chinese adults with cHL, providing valuable insights into its real-world application. Methods: This is a subgroup analysis from a multicentre, prospective, observational RW study (BRAVE study; NCT04837222), which enrolled patients across 32 centers from June 7, 2021, to June 19, 2024. Eligible participants included patients (pts) aged ≥18 years, confirmed with CD30-positive cHL, who received BV-containing treatment regimens. The primary endpoint was serious adverse events (SAEs), and the secondary endpoints included adverse events (AEs), disease characteristics, BV dose intensity, objective response rate (ORR), complete response (CR), progressive-free survival (PFS), and overall survival (OS), etc. Results: A total of 512 patients with cHL were included, comprising 340 (66.4 %) newly diagnosed (ND) pts, and 172 (33.6%) R/R pts, with a median age of 35 years (range, 27–55), and with 19.4% classified as elderly pts (aged ≥60 years) ,and 24.9% in ND pts. The majority were males (N=287, 56.1%), and 5.1% had an ECOG performance status (PS) 2. Among ND patients, 122 (35.9%) and 205 (60.3%) were classified as Ann Arbor stage I-II and III-IV, with 118 (35.0%) pts exhibiting extranodal involvement and 37 (11.0%) having bone marrow infiltration. In the R/R group, 122 patients (70.9%) had stage III-IV disease, and 52.4% had experienced two or more relapses. AEs were observed in 344 patients (67.2 %), including 44 SAEs (8.6%), both lower than those reported in the ECHELON-1 trial (AEs, 99%; SAEs, 39%). Grade ≥3 AEs were observed in 123 patients (24.0%). Hematological SAEs were reported in 15 patients (2.4%). The most common non-hematological SAEs were infections (4.1%) and respiratory disorders (1.0%). Among elderly pts, the incidence of AEs was 70.4%, SAEs were 16.3%, and grade ≥3 AEs were 30.6%. Among ND patients, the median dose intensity was 1.19 (range, 1.03–1.28) mg/kg with a median number of 7.0 (range, 4.0–11.0) doses. More than 85% of pts received BV+AVD, while the remaining patients were treated with BV+PD-1 or BV monotherapy. The ORR and CRR were 86.9% and 59.9%, respectively. For elder pts, the ORR was 79.5% and CR was 45.5% ,while in patients aged 60 years, the ORR and CR were 88.5% and 63%, respectively. Patients with Ann Arbor stage I-II disease had an ORR of 86.7% and CR of 68.9%, while those with stage III-IV disease had an ORR of 87.7% and CR of 54.8%. T The 1-year OS rate was 100 in pts with Ann Arbor stage I-II disease and 97.9% in pts with stage III-IV disease. In the R/R group, the median dose intensity was 1.54 (range, 1.25–1.77) mg/kg with a median number of 5.0 (range, 2.0–7.0) doses. The most commonly used treatment regimen was BV + chemo, followed by BV + PD1 inhibitors. The ORR and CRR were 78.0% and 44.1%, respectively. No significant differences in ORR or CR were observed between BV+chemo (ORR:82%; CR,44%) and BV+PD1 (ORR, 80%; CR, 43.3%). The 1-year OS rate was 94.1 with a median follow-up of 10.7 (9.5–11.9) months. The 1-year OS rate was 82.8% in elderly patients, while the same was 96.6% for those aged 60 years. Conclusion: This is the largest real-world study of brentuximab vedotin in Asian patients with classical Hodgkin lymphoma. No new safety signals were identified relative to clinical trials. Outcomes with BV were similar across Arbor stages in newly diagnosed disease, yet efficacy remains suboptimal in elderly and RR populations, underscoring the need for optimizing BV-based therapeutic protocols.
Liu et al. (Mon,) studied this question.
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