Brentuximab Vedotin-AVD Yields Encouraging Efficacy and Tolerable Safety Among Patients With Classical Hodgkin Lymphoma and HIV

Results from a Multicenter Phase 1/2 Study

Brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (AVD) yielded encouraging efficacy and tolerability among patients with classical Hodgkin lymphoma (cHL) and human immunodeficiency virus (HIV), according to findings from a multicenter phase 1/2 study published in The Lancet Hematology. 

Paul G Rubinstein, MD, University of Illinois, Chicago, Illinois, and coauthors explained that while many studies have brentuximab vedotin-AVD approved to treat advantaged stage cHL, “people living with HIV have been excluded from these studies.” The study authors aimed to investigate the efficacy and safety of brentuximab vedotin-AVD among patients with cHL and HIV, focusing particularly on HIV disease parameters and antiretroviral therapy (ART) interactions. The primary end point was 2-year progression-free survival. 

A total of 41 patients with untreated stage 2 to 4 HIV-associated cHL, a Karnofsky performance status over 30%, a CD4+ T-cell count of 50 cells per μL or more, who were required to take ART, and were not on strong CYP3A4 or P-glycoprotein inhibitors, were enrolled in this study. Patients received 1·2 mg/kg of brentuximab vedotin, which was the recommended phase 2 dose, along with standard doses of AVD, for 6 cycles on days 1 and 15 of a 28-day cycle. 

At a median follow-up of 29 months, 83% of patients (n = 34) presented with stage 3 to 4 unfavorable HIV-cHL, and 17% (n = 7) with stage 2 unfavorable HIV-cHL. A total of 90% of patients (n = 37) reached the end of therapy and achieved complete response. The progression-free survival at 2 years was 87% and the overall survival was 92%. In terms of safety, the most commonly observed grade 3 or higher adverse events were peripheral sensory neuropathy (n = 4), neutropenia (n = 18), and febrile neutropenia (n = 5). Due to infection, 1 case of mortality occurred. 

Dr Rubinstein and coauthors concluded, “Brentuximab vedotin–AVD was highly active and had a tolerable adverse event rate in HIV-cHL and is an important therapeutic option for people with HIV-cHL.”

“The complete response rate is encouraging and is possibly related to a unique aspect of HIV-cHL biology,” they added. 

Source:

Rubinstein PG, Moore PC, Bimali M, et al. Brentuximab vedotin with AVD for stage II–IV HIV-related Hodgkin lymphoma (AMC 085): phase 2 results from an open-label, single arm, multicentre phase 1/2 trial. Lancet Haematol. Published online: August, 2023. doi: 10.1016/S2352-3026(23)00157-6