The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental biologics license application for nivolumab (Opdivo) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), according to a press release from Bristol Myers Squibb. The Prescription Drug User Fee Act (PDUFA) target date is April 8, 2026.
The application was supported by data from the phase 3 SWOG S1826 (CA2098UT) trial (NCT03907488). Updated 3-year progression-free survival (PFS) results were presented at the 2025 American Society of Hematology (ASH) Annual Meeting.
“FDA’s acceptance of our supplemental application for priority review represents an important milestone as we seek to offer a new first-line treatment option for adolescents and adults with advanced-stage cHL,” said Monica Shaw, senior vice president of Oncology Commercialization at Bristol Myers Squibb. “Nivolumab combined with AVD has the potential to set a new standard of care in frontline therapy, addressing the unmet need for durable and meaningful outcomes early in the treatment journey. We look forward to working closely with the FDA to bring this option to patients as soon as possible.”
In the trial, 994 patients were randomly assigned 1:1 to receive either nivolumab at 240 mg plus AVD on days 1 and 15 for 6 cycles (n = 470) or brentuximab vedotin (Adcetris) at 1.2 mg/kg plus AVD on days 1 and 15 for 6 cycles (n = 470).
After 3 years, the PFS rate was 91% (95% CI, 88%-93%) in the nivolumab plus AVD arm compared with 82% (95% CI, 78%-85%) in the brentuximab vedotin plus AVD arm (P < .0001). Among adolescents, the 3-year PFS was 93% (95% CI, 87%-96%) for nivolumab versus 82% (95% CI, 73%-88%) for brentuximab vedotin (stratified log-rank P = .004).
Subgroup analyses showed that patients with an international prognostic score (IPS) of 0–3 had a 3-year PFS of 92% (95% CI, 88%-95%) with nivolumab versus 84% (95% CI, 80%-88%) with brentuximab vedotin (HR, 0.45; 95% CI, 0.28–0.72). For those with IPS 4–7, 3-year PFS was 87% (95% CI, 81%-92%) versus 77% (95% CI, 69%-83%) (HR, 0.57; 95% CI, 0.33–0.97).
Event-free survival (EFS) at 3 years was also improved with nivolumab plus AVD at 87% (95% CI, 84%-90%) versus 80% (95% CI, 76%-83%) with brentuximab vedotin plus AVD (HR, 0.56; 95% CI, 0.41–0.78). Major EFS events included disease progression/relapse (8.2% vs 14.9%) and death without progression (1.2% vs 2.7%).
Three-year overall survival (OS) was 98% (95% CI, 97%-99%) with nivolumab plus AVD versus 97% (95% CI, 95%-98%) with brentuximab vedotin plus AVD (HR, 0.48; 95% CI, 0.20–1.15). Secondary malignancies occurred in 1.2% of patients in the nivolumab arm versus 2.3% in the brentuximab vedotin arm.
“These findings reinforce nivolumab plus AVD as a frontline standard-of-care option for advanced-stage cHL,” said Alex F. Herrera, MD, chief of the Division of Lymphoma at City of Hope. “This regimen is now supported as a category 1 recommendation in NCCN guidelines.”
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