In patients with advanced-stage classical Hodgkin lymphoma (cHL), use of the BrECADD regimen appeared noninferior to eBEACOPP in an interim analysis of the phase 3 HD21 trial. Results were presented as a late-breaking abstract at the International Conference on Malignant Lymphoma 2023by Dr Peter Borchmann of University of Cologne, Germany, and colleagues.
This international, open-label study (ClinicalTrials.gov Identifier: NCT02661503) enrolled adults 60 years of age or younger with advanced-stage cHL who were beginning first-line therapy. Patients were randomly assigned 1:1 to receive eBEACOPP or BrECADD for 4 to 6 cycles, with the number of cycles guided by results from positron emission tomography performed after 2 cycles of chemotherapy (PET2).
The eBEACOPP regimen includes bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone. BrECADD is a modification of eBEACOPP containing brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone.
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The coprimary endpoint of this analysis was the noninferiority of BrECADD, compared with eBEACOPP, in this population, with demonstration of superiority for treatment-related morbidity. Progression-free survival (PFS) was the primary efficacy endpoint. The interim analysis occurred at an estimated 36 months of follow-up and involved the intention-to-treat population.
There were 1482 patients included in the PFS analysis, with 740 in the eBEACOPP arm and 742 in the BrECADD arm. In each treatment arm, patients had a median age of 34 years (range, 18-61). The International Prognostic Index score was 3 or higher in 46% of patients of the eBEACOPP arm and 47% of those in the BrECADD arm.
At a median follow-up of 40 months, the 3-year PFS rate for the eBEACOPP arm was 92.3%, compared with 94.9% for the BrECADD arm (hazard ratio [HR], 0.63 [99% CI, 0.37-1.07). The HR met criteria for regarding BrECADD as noninferior to eBEACOPP in this study.
There were PFS events recorded in 8.4% of patients in the eBEACOPP arm and in 5.3% of patients in the BrECADD arm. The 3-year rate of overall survival was 98.5% in each treatment arm.
The study investigators concluded that the interim analysis of this trial showed noninferiority for BrECADD in comparison with eBEACOPP in this population. “These mature survival results demonstrate that individualized treatment with PET2-guided BrECADD is the most effective therapy currently available for advanced-stage, classical Hodgkin lymphoma and thus sets a new benchmark for the primary cure rate in advanced-stage, classical Hodgkin lymphoma in adult patients,” Dr Borchmann said in his presentation.
Disclosures: This research was supported by Takeda. Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Reference
Borchmann P, Moccia AA, Greil R, et al. BrECADD is non-inferior to eBEACOPP in patients with advanced stage classical Hodgkin lymphoma: efficacy results of the GHSG phase III HD21 Trial. ICML 2023. June 13-17, 2023. Abstract LBA5.
