Combining nivolumab with front-line chemotherapy and radiotherapy appears to be effective in early-stage, unfavorable Hodgkin lymphoma, according to research published in the Journal of Clinical Oncology.
Previous research has indicated that therapies targeting programmed death protein 1 (PD-1) are effective in the HL setting. There are also trials are investigating PD-1-targeting therapies in the first line.
The randomized German Hodgkin Study Group (GHSG) phase 2 NIVAHL trial is among these, and evaluated the safety and efficacy of nivolumab, a PD-1 inhibitor, with doxorubicin, vinblastine, and dacarbazine (N-AVD) followed by radiotherapy in the setting of early-stage, unfavorable HL. For the present paper, the researchers presented 3-year follow-up data from the NIVAHL trial.
There were 2 study groups: concomitant N-AVD and sequential N-AVD, to which 55 and 55 patients were randomly assigned, respectively. Among the 109 patients in the overall study, the median age was 27 years, 59.63% of patients were female sex, 76.15% of patients had a performance status of 0, and 75.23% of patients had Ann Arbor stage IIA disease.
The median follow-up was 41 months. At this point, overall survival was 100% in both groups; progression-free survival was 98% in the sequential N-AVD cohort and 100% in the concomitant N-AVD cohort. Furthermore, the overall mean forced expiratory pressure per 1 second was 95.5%, while the mean diffusion capacity for carbon monoxide-adjusted for hemoglobin was 82.8%.
Hyperthyroidism necessitating long-term treatment was noted in 15% of patients, most of whom (87%) were female sex. No patients developed a secondary malignancy.
Further quality of life analysis suggested that there were improvements over the treatment period.
“In conclusion, this preplanned final analysis of the phase II NIVAHL trial provides important confirmation of the outstanding efficacy and relatively favorable side effect profile of anti–PD-1-based HL first-line treatment with [progression-free survival] and [overall survival] of 99% and 100% at a median [follow-up] of 41 months, respectively,” the authors wrote in their report.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures.
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. Published online December 12, 2022. doi:10.1200/JCO.22.02355