Nivolumab plus chemotherapy appears more effective than brentuximab vedotin plus chemotherapy in patients with advanced stage classic Hodgkin lymphoma, according to research presented at the ASCO Annual Meeting 2023.
Nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD) demonstrated superior progression-free survival (PFS) and event-free survival (EFS), when compared with brentuximab vedotin plus AVD in the S1826 trial, the largest phase 3 trial of its kind.
“Based on these results, nivolumab-ABD is poised to be a new standard therapy for the treatment of advanced-stage Hodgkin lymphoma,” said study presenter Alex Francisco Herrera, MD, of the City of Hope Medical Center in Duarte, California.
The S1826 trial (ClinicalTrials.gov Identifier: NCT03907488) enrolled patients age 12 and older with newly-diagnosed, advanced-stage classic Hodgkin lymphoma. All patients received the same chemotherapy backbone of AVD at conventional doses, and they were randomly assigned to receive either nivolumab or brentuximab vedotin.
Patients in both arms received 6 cycles of the assigned chemoimmunotherapy. A majority of patients received G-CSF as well — 95% in the brentuximab vedotin arm and 54% of those in the nivolumab arm. Radiotherapy was given to few patients — 0.8% and 0.4%, respectively.
The efficacy population included 489 patients who received nivolumab plus AVD and 487 patients who received brentuximab vedotin plus AVD. Baseline characteristics were well balanced between the arms.
At a median follow-up of 12.1 months, PFS was superior in the nivolumab arm (hazard ratio, 0.48; 99% CI, 0.27-0.87; P =.0005). The 1-year PFS rate was 94% in the nivolumab arm and 86% in the brentuximab vedotin arm.
EFS was also superior in the nivolumab arm (hazard ratio, 0.56; 99% CI, 0.33-0.95; P =.0019). The 1-year EFS rate was 91% in the nivolumab arm and 84% in the brentuximab vedotin arm.
Overall survival (OS) data were not yet mature, but the 1-year OS rate was 99% in the nivolumab arm and 98% in the brentuximab vedotin arm.
The safety analysis included 483 patients in the nivolumab arm and 473 in the brentuximab vedotin arm. Dr Herrera noted that fatigue, gastrointestinal toxicities, and hematologic toxicities were the most common adverse events.
The rate of neutropenia was higher in the nivolumab arm than in the brentuximab vedotin arm (55% and 32%, respectively). Patients in the brentuximab vedotin arm were more likely to report bone pain (20% and 8%, respectively).
Infectious toxicity was similar between the treatment arms, but neuropathy was more common in the brentuximab vedotin arm. Infections and infestations were reported in 5% of patients in the nivolumab arm and 8% of those in the brentuximab vedotin arm. Peripheral sensory neuropathy occurred in 29% of patients in the nivolumab arm and 55% of those in the brentuximab vedotin arm. Peripheral motor neuropathy occurred in 4% and 7%, respectively.
“S1826 was the largest Hodgkin lymphoma clinical trial conducted in the history of the North American Cooperative Groups and the first prospective collaboration between the adult and pediatric NCTN Cooperative Groups,” Dr Herrera said.
He added that the results of this trial represent a key step toward harmonizing the treatment of classic Hodgkin lymphoma in adult and pediatric patients. Follow-up is ongoing to confirm the durability of the PFS benefit as well as to assess long-term safety, OS, and patient-reported outcomes.
Disclosures: This research was partly supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Herrerra A, LeBlanc ML, Castellino SM, et al. SWOG S1826, a randomized study of nivolumab(N)-AVD versus brentuximab vedotin(BV)-AVD in advanced stage (AS) classic Hodgkin lymphoma (HL). ASCO 2023. June 2-6, 2023. Abstract LBA4.
This article originally appeared on Hematology Advisor