Both study arms used PET scans to guide treatment decisions. The data results of the HD21 study were presented in a late-breaking session at the 17th
An interim analysis at 40 months showed an unprecedented 94.9% 3-year progression-free survival (PFS) (99% CI: 92.8, 97.1) for patients treated with the ADCETRIS combination of BrECADD versus 92.3% for eBEACOPP (99% CI: 89.7, 94.9). 12-month post-treatment safety data were consistent with previously presented HD21 data results at the
ADCETRIS + AVD chemotherapy (Adriamycin, vinblastine, dacarbazine) is a
'Our mission in Hodgkin lymphoma is to cure patients with a first-line treatment that reduces the risk of cancer returning as much as possible so patients can go on with their lives,' said Professor Dr. med.
'We are enthusiastic about these strong and durable efficacy outcomes and tolerability findings of an ADCETRIS based chemotherapy regimen compared to an international standard chemotherapy. We are evaluating these results to determine next steps,' said
Results from the GHSG's HD21 Trial
Among 1,482 patients at median follow up of 40 months, an intent-to-treat analysis showed: 3-year PFS was 94.9% for BrECADD vs. 92.3% for eBEACOPP (HR=0.63 [99% CI: 0.37, 1.07])
1-year PFS was 97.5% for BrECADD (99% CI: 96, 99)
3-year overall survival was 98.5% in both treatment arms
12-month post-treatment safety information was available for 95 percent of patients (n=1,395), which showed the rate of grade 2 peripheral neuropathy was lower with BrECADD (1.9%) vs. eBEACOPP (2.7%) with most patients having no or low (grade 1) peripheral neuropathy (98.1% for BrECADD vs. 97.3% for eBEACOPP).
Preservation of fertility potential was indicated by measurement of follicle-stimulating hormone (FSH) and was available for 597 patients. 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.
About the HD21 Study
The GHSG's phase 3 HD21 trial in advanced cHL enrolled 1,500 patients from 9 countries between
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