20 Jun 2023: Adcetris (Brentuximab vedotin) / Classical Hodgkin Lymphoma (cHL) / Seagen: Phase 3 GHSG’s HD21 trial met its co-primary endpoints
Seagen reported positive data from the Phase 3 GHSG’s HD21 study of Brentuximab vedotin + Chemo (BrECADD) vs BEACOPP regimen in advanced classical Hodgkin lymphoma (cHL)
Results: median follow-up: 40 months
Efficacy: n = 1,482
3-year PFS: 94.9% (BrECADD) vs. 92.3% (eBEACOPP)
1-year PFS: 97.5% for BrECADD
3-year OS was 98.5% in both treatment arms
Safety: n = 1,395
Rate of grade ≥2 peripheral neuropathy was lower with BrECADD (1.9%) vs eBEACOPP (2.7%)
Most patients had no or low (grade 1) peripheral neuropathy: 98.1% (BrECADD) vs 97.3% (eBEACOPP)
Preservation of fertility potential was numerically favorable for the BrECADD arm vs eBEACOPP
Mean FSH levels were 29.4 and 31.8 after 4 and 6 cycles, respectively for eBEACOPP, and 18.3 and 20.5 after 4 and 6 cycles, respectively, for BrECADD
Persistently elevated FSH is associated with impaired gonadal function
Additional analysis is required to understand the significance of these findings
“The mature results of this study demonstrate 3-year efficacy never previously observed in a phase 3 trial in advanced cHL and suggest that the BrECADD regimen may be the most effective therapy regimen currently available in advanced cHL.” said Professor Dr. med. Peter Borchmann, Assistant Medical Director, Department of Hematology and Oncology at the University Hospital of Cologne, Germany, and Head of the Lymphoma Program