The combination of nivolumab plus brentuximab vedotin (BV) with risk-adapted intensification of BV plus bendamustine resulted in high complete metabolic response (CMR) rates among children and adolescents and young adults (CAYAs) with relapsed/refractory Hodgkin lymphoma (HL). In addition, the majority of patients did not require bendamustine intensification.
The phase 2 CheckMate 744 trial (ClinicalTrials.gov identifier: NCT02927769) comprised standard- and low-risk cohorts. Results of the standard-risk cohort of 44 patients was published in Blood.
All patients were treated with nivolumab plus BV induction for 4 cycles. Consolidation included nivolumab plus BV and, for patients who did not achieve CMR after induction, BV plus bendamustine. The primary endpoint was CMR any time before consolidation.
The median age of the cohort was 16 years and 66% of patients were male. There were 55% of patients who had primary refractory HL and 32% whose disease relapsed between 3 to 12 months and 14% with relapse 12 months or longer after completing first-line treatment. None of the patients had previously received BV or undergone an autologous hematopoietic cell transplant. Bone marrow involvement was present among 11% of patients and stage IV disease was present at relapse among 36%.
Induction with nivolumab plus BV resulted in a CMR rate of 59%, which increased to 82% after 2 cycles of intensification with BV plus bendamustine, and 94% at any time before consolidation. The overall response rate was 100%. The CMR rates were also high among patients with primary refractory HL, with a rate of 87% any time before consolidation.
A 25% or greater reduction in tumor volume was achieved by 97% of patients, with 94% achieving a 50% or greater reduction. The median duration of response was not yet reached. The 1-year progression-free survival was 91% and the median was not yet reached.
Treatment-related adverse events (TRAEs) of grade 3-4 severity occurred among 18% of patients during induction and 27.3% during intensification. During induction, the most common any grade TRAE were hypersensitivity, nausea, and diarrhea. During intensification, the most common any grade TRAEs were vomiting, nausea, infusion-related reaction, and headache.
“The notable CMR rates after induction with nivolumab plus BV suggest that intensification with BV plus bendamustine could be safety reserved for a subset of patients with an inadequate response to induction therapy, thereby eliminating additional exposure to alkylators for most patients,” the authors concluded in their report.
Disclosures: This study was supported by Bristol Myers Squibb in collaboration with Seagen. Please see the original reference for a full list of disclosures.
Harker-Murray P, Mauz-Körholz C, Leblanc T, et al. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023;141:2075-2084. doi: 10.1182/blood.2022017118
This article originally appeared on Hematology Advisor