A 3-year update of nivolumab plus doxorubicin, vinblastine, and dacarbazine (N-AVD) confirmed the high complete response rate, progression-free survival (PFS), and safety among patients with early-stage, unfavorable Hodgkin lymphoma (HL), according to the results of the final analysis of the phase 2 NIVAHL trial published in the Journal of Clinical Oncology.
Immune checkpoint inhibitors are effective treatment for relapsed/refractory HL and are now being studied as first-line treatment. However, most trials to date have been small and short-term. The aim of this investigator-initiated trial was to evaluate the safety and efficacy of N-AVD with long-term follow-up.
The open-label, phase 2 NIVAHL trial randomly assigned 109 patients with newly-diagnosed, early-stage, unfavorable HL to receive concomitant N-AVD for 4 cycles or sequential treatment with 4 cycles of nivolumab followed by 2 cycles of N-AVD then 2 cycles of AVD. Both groups were consolidated with 30 Gy of involved-site radiotherapy. This report is of the final, 3-year analysis.
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There were no PFS or overall survival (OS) events, resulting in an estimated 3-year PFS of 99% and OS of 100% for all patients. There was 1 patient who developed disease progression during nivolumab monotherapy in the sequential group, who then achieved complete response (CR) after switching to standard therapy.
The rate of adverse events (AEs) was similar between the treatment groups and were primarily grade 1 or 2 in severity. Late AEs associated with nivolumab only included hypothyroidism and hepatobiliary disorders.
The authors concluded that these results “provides important confirmation of the outstanding efficacy and relatively favorable side effect profile of anti-PD-1-based HL first-line treatment.”
Disclosures: This study was supported in part by Bristol Myers Squibb. Please see the original reference for a full list of disclosures.
Reference
Bröckelmann PJ, Bühnen I, Meissner J, et al. Nivolumab and doxorubicin, vinblastine, and dacarbazine in early-stage unfavorable Hodgkin lymphoma: final analysis of the randomized German Hodgkin Study Group Phase II NIVAHL Trial. J Clin Oncol. 2023;41:1193-1199. doi: 10.1200/JCO.22.02355
