German researchers report that concurrent or sequential treatment with immunotherapy or chemotherapy improves clinical outcomes in patients with early unfavourable-risk Hodgkin’s lymphomas (HL). These findings were recently published in the Journal of Clinical Oncology.
Immunotherapy is being investigated alone or in combination with other drugs in many cancers, including HL. In the NIVAHL phase-II study, the researchers used anti-PD-1 antibodies, i.e. nivolumab (N) plus chemotherapy, i.e. doxorubicin, vinblastine, and dacarbazine (AVD) and observed a very high complete remission (CR) of 92%. Phase III of the NIVAHL study has analysed the combinatorial treatment’s long-term survival and safety data.
The investigator-sponsored open-label multicentre NIVAHL study recruited 109 patients with histologically confirmed unfavourable HL. The participants were randomly administered either four cycles of N-AVD (n= 55) concomitantly or four cycles of nivolumab, two cycles of N-AVD, and two cycles of AVD (n= 54) sequentially. This was followed with 30Gy involved-site radiotherapy in both groups. The study’s pre-planned analysis was conducted three years after the registration of the first patient.
All the participants in the concomitant-treatment group had 100% estimated 3-year progression-free survival (PFS) and overall survival (OS). In the sequential-treatment group, the estimated 3-year rates were 98% (PFS) and 100% (OS).
Disease progression was observed in one patient receiving sequential treatment. Grade 1/2 treatment-related adverse events (AEs) were observed in 3/4th of the participants, and grade 3 AEs were reported in 9% of patients. Further, hypothyroidism requiring long-term medication was reported in 15% of patients.
The findings of the NIVAHL study demonstrate the superior efficacy and safety of N-AVD as a first-line treatment for early-stage unfavourable HL.
Bröckelmann PJ, 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. 2022 Dec 12:JCO2202355. doi: 10.1200/JCO.22.02355.