The sBLA acceptance is based on data from the phase 3 SWOG S1826 study (NCT03907488). At a median follow-up of 12.1 months (range, 0-38.6), findings from the primary of analysis published in The New England Journal of Medicine demonstrated that patients who received nivolumab plus AVD (n = 487) achieved a significant progression-free survival (PFS) benefit compared with those treated with brentuximab vedotin (Adcetris) plus AVD (n = 483; HR, 0.48; 99%CI, 0.27-0.87, 2-sided P < .001). The 1-year PFS rates were 94% (95% CI, 91%-96%) vs 86% (95% CI, 82%-90%), respectively.
“The FDA’s acceptance of our sBLA for priority review marks a pivotal milestone as we aim to bring a new and much-needed first-line option to adolescents and adults newly diagnosed with advanced-stage classical Hodgkin lymphoma,” Monica Shaw, senior vice president of oncology commercialization at Bristol Myers Squibb, stated in a news release.1 “[Nivolumab] in combination with AVD represents a potential new standard of care in the frontline treatment of advanced classical Hodgkin lymphoma for adolescents and adults.”
How was SWOG S1826 designed?
SWOG S1826 was an international, open-label trial that enrolled patients at least 12 years of age with previously untreated stage III or IV classical Hodgkin lymphoma.2 Patients needed to have a Zubrod performance status of 0 to 2 and adequate hematologic and organ function. Those with controlled HIV infection were eligible.
Patients were randomly assigned 1:1 to receive nivolumab at 240mg in adults and 3 mg/kg in pediatric patients (capped at 240 mg), or brentuximab vedotin at 1.2mg/kg (capped at 100kg), both in combination with doxorubicin 25mg/m2, vinblastine 6mg/m2, dacarbazine 375mg/m2. Treatment in both arms was administered intravenously on days 1 and 15 of each 28-day cycles for 6 cycles.
The primary end point was PFS. Key secondary end points included safety, overall survival (OS), and event-free survival.
What were the additional efficacy data and safety results?
At a median follow-up of 2.1 years (range, 0-4.2), the 2-year PFS rates in the investigational and control arms were 92% (95% CI, 89%-94%) and 83% (95%CI, 79%-86%), respectively. The respective 2-year OS rates were 99% (95% CI, 97%-100%) and 98% (95% CI, 96%-99%). The HR for OS was 0.39 (95% CI, 0.15-1.03).
In the safety population, the most common any-grade adverse effects (AEs) in the nivolumab arm (n = 482) were nausea (65%), decreased neutrophil count (56%), and fatigue (47%). The most common any-grade AEs in the control arm (n = 476) were nausea (70%), peripheral sensory neuropathy (56%), and fatigue (51%).
“Hodgkin lymphoma remains a challenging disease, with an ongoing need for therapies that may deliver meaningful and durable outcomes early in a patient’s treatment journey,” Shaw added in the news release.1 “We look forward to collaborating with the FDA throughout the review process to bring this important option to patients as quickly as possible.”
References
- U.S. Food and Drug Administration (FDA) grants priority review to Bristol Myers Squibb's application for Opdivo (nivolumab) plus chemotherapy combination for classical Hodgkin lymphoma. News release. Bristol Myers Squibb. December 11, 2025. December 11, 2025. https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-FDA-Grants-Priority-Review-to-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-Plus-Chemotherapy-Combination-for-Classical-Hodgkin-Lymphoma/default.aspx
- Herrera AF, LeBlanc M, Castellino SM, et al. Nivolumab+AVD in advanced-stage classic Hodgkin's lymphoma. N Engl J Med. 2024;391(15):1379-1389. doi:10.1056/NEJMoa2405888
