Two strategies including nivolumab as first-line treatment resulted in significant complete remission and progression-free survival rates for patients with early-stage unfavorable classic Hodgkin lymphoma (cHL), according to a study published in JAMA Oncology.
A team of investigators in Germany conducted NIVAHL, an open-label, phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT03004833), to determine how effectively 2 experimental nivolumab-based therapies would treat patients with early-stage unfavorable cHL. The multicenter trial was conducted in 35 centers and included 109 eligible patients aged 18 to 60 years.
The primary outcome measured complete remission following the completion of study treatment.
Participants (59.6% women; median age, 27 years) were randomly assigned to receive either concomitant treatment with 4 cycles of nivolumab and doxorubicin, vinblastine, and dacarbazine (N-AVD) or sequential treatment with 4 doses of nivolumab, 2 cycles of N-AVD, and 2 cycles of standard doses of AVD, followed by 30-Gy involved-site radiotherapy.
All participants receiving 2 cycles of N-AVD (54 patients) and 96% of those receiving 4 doses of nivolumab monotherapy (51 patients) achieved an objective response at interim staging, with 87% and 52% of patients, respectively, achieving complete remission.
Following interim staging, 101 patients were eligible for primary end point analysis, at which point 51 patients were treated with concomitant therapy and 50 patients were treated with sequential therapy. Of these eligible participants, 90% and 94% receiving concomitant therapy and sequential therapy, respectively, achieved complete remission following study treatment. The median follow-up was 13 months; 100% of patients in the concomitant cohort and 98% of patients in the sequential therapy cohort reported 12-month progression-free survival. While complete remission was highly successful, the investigators noted that limited follow-up so far was a limitation of the study.
“While we conclude excellent short-term disease control, the long-term efficacy and curative potential as well as potential late effects of both treatment strategies are to be determined with the designated longer follow-up of 3 years within the NIVAHL trial,” the researchers wrote.
Bröckelmann PJ, Dipl-Math HG, Keller U, et al. Efficacy of nivolumab and AVD in early-stage unfavorable classic Hodgkin lymphoma: the randomized phase 2 German Hodgkin Study Group NIVAHL Trial [published online April 30, 2020]. JAMA Oncol. doi: 10.1001/jamaoncol.2020.0750